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  • FDA’s Fast Track designation for oral orismilast underscores the urgent need for new treatment option with potential to fulfil the unmet medical needs for people affected by atopic dermatitis (AD)
  • AD is the most common chronic inflammatory skin disease in the developed world
  • Orismilast is a next generation PDE4 inhibitor with broad anti-inflammatory properties also in development for the treatment of psoriasis and hidradenitis suppurativa (HS)

Hellerup, Denmark, 4 November 2021 – UNION therapeutics A/S, a privately-held, multi-asset, clinical stage, pharmaceutical company focused on immunology and infectious diseases, today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to oral orismilast for the treatment of moderate to severe AD. The FDA's Fast Track designation is intended to facilitate the development and review of drug candidates that treat serious conditions and address an unmet medical need. A drug candidate that receives Fast Track designation is eligible for more frequent interaction with the FDA to discuss the drug candidate's development plan as well as eligibility for rolling review and priority review.

Kim Kjøller, Chief Executive Offer of UNION therapeutics said:
“We are very pleased to receive this Fast Track designation for oral orismilast and look forward to working closely with the FDA. We believe that oral orismilast holds great promise and has the potential to become an efficacious treatment option for patients who need systemic therapy for atopic dermatitis without the safety issues associated with oral corticosteroids.”

Jonathan Silverberg, MD, PhD, MPH and well recognized KOL adds:
Atopic dermatitis is one of the most common chronic skin diseases worldwide. Despite the recent advancements in the treatment of atopic dermatitis, there is still a high unmet need in terms of safe and efficacious oral treatments that can be used before biologics. It is encouraging to see that FDA recognizes the potential of orismilast in atopic dermatitis and grants it fast track designation, which would bring orismilast one step closer to patients.

About orismilast
Orismilast is a potent and selective next generation PDE4 inhibitor. PDE4 inhibition works high in the inflammation cascade and as such has the potential to inhibit many autoimmune pathways involved in dermatologic diseases. The safety and tolerability of PDE4 inhibitors is well understood, with two oral treatments and one topical approved and marketed.

Two challenges exist for the currently commercialized oral PDE4 inhibitors: their overall efficacy within existing indications tends to be moderate and they are limited by gastrointestinal side effects which worsens with dose increase. This represents challenges for an effective PDE4 therapy1). Orismilast was selected to improve anti-inflammatory potency whilst minimizing gastrointestinal side effects. Additionally, orismilast has demonstrated clinical proof-of-concept in both psoriasis and AD patients.

UNION therapeutics has two product candidates with orismilast in its clinical stage pipeline: UNI50001, an oral PDE4 inhibitor currently investigated for the treatment of psoriasis, AD and HS; and UNI50002, a non-steroidal topical PDE4 inhibitor currently investigated for the treatment of AD.

About atopic dermatitis
Atopic dermatitis is a chronic inflammatory skin disease affecting approximately 3% of the adult population worldwide and is the most common skin disease among children, with the disease commonly occurring by five years of age2). There was approximately 26 million diagnosed cases of AD in 2021 in the Seven Major Markets (US, France, Germany, Italy, Spain, UK, and Japan). Disease symptoms are characterized by recurrent eczematous skin lesions and intense itch. AD has a substantial psychosocial impact on patients and relatives3). During disease flares, approximately 80% of patients may experience disturbed sleep, which may also disrupt the sleep of family members4). The disease impacts the mood and affected individuals may experience depression5).

Sources

  1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4517531/pdf/ptj4008495.pdf and https://onlinelibrary.wiley.com/doi/10.1111/bjd.14164
  2. https://pubmed.ncbi.nlm.nih.gov/25925336/
  3. https://pubmed.ncbi.nlm.nih.gov/33006135/
  4. https://pubmed.ncbi.nlm.nih.gov/24290431/
  5. https://pubmed.ncbi.nlm.nih.gov/27616422/

Contacts

UNION therapeutics A/S
Morten Boesen, Chief Financial Officer
+45 2381 5487
[email protected]

Media enquiries

UNION therapeutics A/S
Sarah Toft-Jørgensen, Director of Communications and IR
+45 5385 3044
[email protected]


About UNION therapeutics
UNION therapeutics is a privately-held, multi-asset, clinical stage, pharmaceutical company focused on immunology and infectious diseases. The company is currently working with two complementary chemistry classes, spanning immunology and microbiology with seven programs in clinical development. UNION is headquartered in Hellerup, Denmark, and led by an international team combining biotech entrepreneurs and senior pharma executives, with a track record of developing and launching more than fifteen marketed drugs. Read more at www.uniontherapeutics.com

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  • PREVENT1) is an exploratory Phase 2 study of niclosamide nasal spray (UNI91103) in asymptomatic or mildly symptomatic COVID-19 infected patients
  • UNI91103 is a potent inhibitor of SARS-CoV-2 with in-vitro potency >40x higher than remdesivir2)

Hellerup, Denmark, 22 October 2021 – UNION therapeutics A/S, a privately-held, multi-asset, clinical stage, pharmaceutical company focused on immunology and infectious diseases, today announced the enrollment of the first patient in PREVENT, a Phase 2 randomized, placebo-controlled double-blind study in COVID-19. The primary objective of this study is to investigate if intranasal niclosamide can prevent development and halt progression of symptoms in participants who are infected with COVID-19 but have either no or only mild symptoms upon enrollment.

PREVENT is the first study of intranasally administered niclosamide in COVID-19 infected patients. UNI91103 is currently also being tested as experimental prophylactic agents in immunocompromised individuals who may require additional protection from COVID-19 in addition to vaccination (PROTECT-V). Studies in COVID-19 patients follow promising safety and pharmacokinetic results for intranasal and inhaled (UNI91104) niclosamide in a Phase 1 trial published in the Lancet.3)

Per Cantor, Chief Medical Officer of UNION therapeutics said:
“This is the first time we study our UNI91103 nasal spray for early virus intervention in patients. Niclosamide has the potential to become a truly differentiated therapeutic for prevention and treatment of COVID-19 infection and potentially other respiratory infections. Building on the positive safety findings in the Phase 1 trial with intranasal and inhaled niclosamide, and studies by Institut Pasteur Korea identifying niclosamide as one of the most potent inhibitors of SARS-CoV-2, we look forward to further advancing niclosamide in clinical trials.”

About the PREVENT study
UNION has designed a program to test niclosamide in different stages of the disease, ranging from prophylaxis to treatment based on preclinical efficacy data of niclosamide and supportive findings from the Phase 1 study. The PREVENT study is designed to test whether intranasal niclosamide (UNI91103) administered twice daily over a 10-day period can serve as an early intervention and halt progression of symptoms in participants who are infected with COVID-19 but have either no or only mild symptoms upon enrollment. The trial also aims to determine if UNI91103 reduces the rate of hospitalization due to COVID-19, dissemination of COVID-19 to household contacts and the COVID-19 viral load. The study will initially be conducted at multiple sites in Germany.

COVID-19 platform trials with niclosamide
UNION’s aerosolized niclosamide products have been selected for leading international platform trials in COVID-19 and is being tested in multiple COVID-19 disease stages. In the PROTECT-V platform study, niclosamide nasal spray is currently being investigated as prophylaxis in patients at risk of COVID-19 infection, such as patients on dialysis, with kidney transplant or with vasculitis/glomerulonephritis. The study is led by the Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge.

About niclosamide in COVID-19
In March 2020, studies undertaken by Institut Pasteur Korea identified niclosamide as one of the most potent inhibitors of SARS-CoV-2; the virus causing COVID-19 based on in-vitro studies4). UNION has more than six years of preclinical and clinical experience with niclosamide and has utilized these insights to advance several niclosamide-based treatments for COVID-19. UNI91103 (nasal spray) and UNI91104 (nasal spray and nebulizer) are two proprietary products developed by UNION based on niclosamide for local administration to the respiratory tract. By delivering niclosamide directly to the lungs and the nasal cavity, UNI91103 and UNI91104 circumvents low bioavailability of niclosamide administered orally. UNI91103 has been selected as a “Priority 1” candidate for COVID-19 by Airfinity and ranks among 1 of 13 antiviral candidates in development.5)

Contacts

UNION therapeutics A/S
Morten Boesen, Chief Financial Officer
+45 2381 5487
[email protected]

Media enquiries

UNION therapeutics A/S
Sarah Toft-Jørgensen, Director of Communications and IR
+45 5385 3044
[email protected]

Sources:

  1. ClinicalTrials.gov identifier (NCT number): NCT04932915
  2. https://journals.asm.org/doi/full/10.1128/AAC.00819-20
  3. https://www.sciencedirect.com/science/article/pii/S2666776221000715
  4. https://www.biorxiv.org/content/10.1101/2020.03.20.999730v2.full.pdf
  5. Airfinity; Priority 1 is defined by Airfinity as: “Candidates that have/are expected to report positive late phase randomized trial results that have received regulatory approval”

 

About UNION therapeutics
UNION therapeutics is a privately-held, multi-asset, clinical stage, pharmaceutical company focused on immunology and infectious diseases. The company is currently working with two complementary chemistry classes, spanning immunology and microbiology with seven programs in clinical development. UNION is headquartered in Hellerup, Denmark, and led by an international team combining biotech entrepreneurs and senior pharma executives, with a track record of developing and launching more than fifteen marketed drugs. Read more at www.uniontherapeutics.com

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  • OSIRIS is an investigator-led, proof-of-concept Phase 2 study of orismilast for the treatment of mild to severe hidradenitis suppurativa (HS)
  • HS is a scarring inflammatory skin disease with significant unmet treatment need
  • Orismilast is a next generation PDE4 inhibitor with broad anti-inflammatory properties also in development for the treatment of psoriasis and atopic dermatitis

Hellerup, Denmark, 14 October 2021 – UNION therapeutics A/S, a privately-held, multi-asset, clinical stage, pharmaceutical company focused on immunology and infectious diseases, today announced the enrollment of the first patient in OSIRIS, a Phase 2, open-label, proof of concept study of an oral tablet formulation of orismilast in adult patients with mild, moderate and severe HS. The primary objective of OSIRIS is to explore evidence of efficacy of oral orismilast in the treatment of patients with HS for up to 16 weeks. Orismilast is currently in Phase 2 of clinical development for various inflammatory skin diseases, including psoriasis and atopic dermatitis.

The investigator-initiated, single-site OSIRIS study is led by Professor Gregor B. Jemec, Founding Chairman of the Department of Dermatology, Zealand University Hospital Roskilde, Denmark. Dr. Jemec is at the global forefront of HS research, contributing significantly to the definition and management of the disease with more than 200 publications so far.

Professor Gregor B. Jemec said:
“Hidradenitis suppurativa is an autoimmune systemic skin disease. It causes wide-spread inflammation and scarring causing serious detrimental effects on the quality of life of patients. Yet it has only limited treatment options, that often provide only temporary symptomatic relief. There is a significant and urgent unmet need for an effective therapy. We are therefore very pleased to be able to enroll the first of 24 patients in the study and hope that orismilast as an innovative oral approach will demonstrate benefit in the management of this devastating illness.”

Kim Kjøller, Chief Executive Officer of UNION therapeutics said:
“While HS may be a niche indication, it has serious consequences for the patient. Due to chronic pain, drainage, and malodor associated with lesions, the condition imposes a significant burden on patients’ quality of life. With limited treatment options today, we are eager to support Gregor B. Jemec and his team at Zealand University Hospital investigating the potential of orismilast for becoming a safe and efficient, first in class, oral treatment for HS.”

About the OSIRIS Phase 2 study
OSIRIS is a phase 2, open-label, single-centre, prospective, single arm, investigator-initiated proof of concept study investigating the efficacy and safety of an oral tablet formulation of orismilast applied twice daily for up to 16 weeks in adult patients with mild, moderate, and severe HS. The clinically relevant primary endpoint is percent change from baseline in abscesses and nodules count at week 16 of treatment. The study will enroll 24 adult patients (men and women); 8 with mild, 8 with moderate, and 8 with severe HS.

About orismilast
Orismilast is a potent and selective PDE4 inhibitor. PDE4 inhibition works high in the inflammation cascade and as such have the potential to inhibit many autoimmune pathways involved in dermatologic diseases such as HS. The safety and tolerability of PDE4 inhibitors is well understood, with two oral treatments and one topical approved and marketed. The selectivity of orismilast for PDE4 subtypes B and D has preclinically resulted in improved anti-inflammatory potency. Orismilast has generated positive proof of concept data orally in psoriasis and topically in atopic dermatitis.

UNION therapeutics has two product candidates with orismilast in its clinical stage pipeline: UNI50001, an oral PDE4 inhibitor currently investigated for the treatment of psoriasis, atopic dermatitis and HS; and UNI50002, a non-steroidal topical PDE4 inhibitor currently investigated for the treatment of atopic dermatitis.

About HS
HS is a chronic, inflammatory skin disease which results in painful inflammation of the hair follicles, most notably in the armpit and genitalia regions. The clinical hallmarks of the disease include very painful inflammatory nodules, boils or abscesses that typically open and release odorous inflammatory fluids. HS patients suffer primarily from pain and significant discomfort resulting from the constant formation of pus, often requiring the use of bandages and diapers, resulting in social isolation. Patients are often stigmatized by these symptoms. Not surprisingly, HS severely and adversely affects patients' quality of life and is associated with an increased overall mortality rate due to cardiovascular disease and completed suicides.

HS is an immune-mediated disorder with an unknown etiology, with many immune pathways activated - expectedly requiring a broad anti-inflammatory approach to achieve good efficacy. Treatment for HS patients typically includes topical, oral or intravenous antibiotic treatment, which often provide only temporary symptomatic relief. In some cases, patients also undergo different types of surgery.

Contacts

UNION therapeutics A/S
Morten Boesen, Chief Financial Officer
+45 2381 5487
[email protected]

Media enquiries
UNION therapeutics A/S

Sarah Toft-Jørgensen, Director of Communications and IR
+45 5385 3044
[email protected]

About UNION therapeutics
UNION therapeutics is a privately-held, multi-asset, clinical stage, pharmaceutical company focused on immunology and infectious diseases. The company is currently working with two complementary chemistry classes, spanning immunology and microbiology with seven programs in clinical development. UNION is headquartered in Hellerup, Denmark, and led by an international team combining biotech entrepreneurs and senior pharma executives, with a track record of developing and launching more than fifteen marketed drugs. Read more at www.uniontherapeutics.com

 

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  • Orismilast is a potential best-in-class PDE4 inhibitor in Phase 2 clinical development for the treatment of atopic dermatitis, psoriasis, and hidradenitis suppurativa
  • Innovent will be granted exclusive rights to research, develop and commercialize orismilast in China (including Mainland China, Hong Kong, Macau and Taiwan)
  • UNION will receive USD 20 million upfront and be entitled to receive additional milestone payments of up to USD 247 million as well as tiered royalties on sales of orismilast in China


Hellerup, Denmark, San Francisco, U.S. and Suzhou, China, 28 September 2021 – UNION therapeutics A/S (‘UNION’), a privately-held, multi-asset, clinical stage, pharmaceutical company focused on immunology and infectious diseases, and Innovent Biologics (HK) Limited, a subsidiary of Innovent Biologics, Inc. (HKEX: 01801, ‘Innovent’), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today announced that they have entered into a strategic collaboration and license agreement for the development and commercialization of orismilast in China.

Under the terms of the agreement, UNION grants Innovent an exclusive license to research, develop and commercialize orismilast in China, including participating in and recruiting Chinese patients for potential future global studies of orismilast. UNION will receive an upfront payment of USD 20 million and is further entitled to receive up to USD 247 million in milestone payments as well as tiered royalties on sales of orismilast in China. UNION will retain global rights for orismilast outside of China.

In China there are approximately fifty million patients suffering from atopic dermatitis and six million patients suffering from psoriasis, and their prevalence is rising with changing lifestyles. Current standard of care treatments are topical steroids, oral immunosuppressants and injectable biologics, all of which have certain limitations in efficacy, safety or route of administration, presenting significant unmet clinical needs. In Phase 2a clinical studies, orismilast has demonstrated potential best-in-class profiles in these conditions with a combination of improved efficacy and tolerability, and could be well positioned to address the unmet needs of these patient populations.

Dr. Yongjun Liu, President of Innovent, said:
We are very pleased to enter a collaboration with UNION. We have been impressed with our partner’s capability to advance the global development of orismilast and we are excited to help bring orismilast to patients in China. This collaboration further strengthens our position in autoimmune by adding a mid-stage potential best-in-class therapy into our portfolio. Innovent is proud to be an ideal partner for worldwide biotech and pharmaceutical companies in terms of accelerating the development and commercialization progress of novel assets to benefit a broader patient population.”

Kim Kjøller, Chief Executive Officer of UNION therapeutics, said:
“We are excited to enter into this strategic collaboration with Innovent, whose deep insights and presence in China make them an ideal partner to bring orismilast to Chinese patients. We are impressed by Innovent’s track record of international partnering, advancing assets through clinical development and commercial execution. This agreement provides independent validation of our belief in the best-in-class potential of orismilast and expands our global footprint in an underserved market with significant potential. Partnering with pharmaceutical companies is core to our strategy of maximizing the value of our product candidates, and we are therefore excited to enter this collaboration with an internationally recognized partner.”

About orismilast
Orismilast is a potent and selective, next-generation PDE4 inhibitor with broad anti-inflammatory properties, which was originally developed by LEO Pharma and acquired by UNION in 2020. Orismilast has generated positive proof of concept data orally in psoriasis and topically in atopic dermatitis and is being developed as a potential best- or first-in-class treatment option in both diseases. The selectivity of orismilast for PDE4 subtypes B and D and the novel modified release delivery is expected to result in an attractive therapeutic window, i.e., the combination of improved efficacy and tolerability, compared to other PDE4 inhibitors.  UNION has two product candidates with orismilast in Phase 2 clinical development: UNI50001, an oral PDE4 inhibitor investigated for the treatment of psoriasis, atopic dermatitis and hidradenitis suppurativa; and UNI50002, the topical formulation of orismilast investigated for the treatment of atopic dermatitis. The safety and tolerability of PDE4 inhibitors is well understood, with two oral treatments and one topical currently approved and marketed.

About Innovent 
Inspired by the spirit of "Start with Integrity, Succeed through Action,” Innovent’s mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune, metabolic and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 26 valuable assets in the fields of cancer, metabolic, autoimmune disease and other major therapeutic areas, with 5 products – TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection) and Pemazyre® (pemigatinib oral inhibitor) – officially approved for marketing in China, 1 asset’s NDA under NMPA review, sintilimab’s Biologics License Application (BLA) acceptance in the U.S., 5 assets in Phase 3 or pivotal clinical trials, and an additional 15 molecules in clinical studies.

Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other international partners. Innovent strives to work with many collaborators to help advance China’s biopharmaceutical industry, improve drug availability and enhance the quality of the patients’ lives. For more information, please visit: www.innoventbio.com and www.linkedin.com/company/innovent-biologics.

About UNION therapeutics
UNION therapeutics is a privately-held, multi-asset, clinical stage, pharmaceutical company focused on immunology and infectious diseases. The company is currently working with two complementary chemistry classes, spanning immunology and microbiology with seven programs in clinical development. UNION is headquartered in Hellerup, Denmark, and is led by an international team combining biotech entrepreneurs and senior pharma executives, with a collective track record of completing more than fifteen product approvals. Read more at www.uniontherapeutics.com

Contacts

UNION therapeutics A/S
Morten Boesen, Chief Financial Officer
[email protected]
+45 2381 5487

Media enquiries in Denmark
Point Communications
Jørgen Fischer Ravn
[email protected]
+45 2030 3903

International media enquiries
Consilium Strategic Communications
Matthew Cole
[email protected]
+44 (0)7593 572 720

 

 

Innovent Biologics, Inc.
Media:
[email protected]
+86 512-6956 6088

Investors:
[email protected]
+86 512-6956 6088

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Hellerup, Denmark, 12 July 2021 – UNION therapeutics A/S, a privately-held, multi-asset, clinical stage pharmaceutical company focused on immunology and infectious diseases, today announced that Gitte Aabo, CEO of GN Hearing A/S, and Arthur Higgins, Senior Advisor to Blackstone Private Equity Group, have been elected to the Board of Directors of UNION. Arthur Higgins has been appointed Deputy Chairman of the Board.

Stig Løkke Pedersen, Chairman of the Board of Directors of UNION, says:
“With their impressive track records, Gitte Aabo and Arthur Higgins are very experienced life science professionals with long executive careers at the highest level in the healthcare industry, spanning from innovation and startup to chief executive positions of large, global companies, directorships, deal-making and financing. Thanks to their comprehensive leadership experience from large and complex organizations, they will provide significant value to the board’s work regarding strategy, governance, and company processes. They complete the board’s competences, and I very much look forward to working with Gitte and Arthur on UNION’s exciting journey.”

Rasmus Toft-Kehler, Co-Founder of UNION and Chief Operating Officer, says:
“I am proud of UNION’s ability to attract very strong board members with proven track records, international network and strategic vision, who can support our ambition to build a sustainable and innovative pharmaceutical company. Gitte Aabo brings deep insights in dermatology from LEO Pharma and relevant experience as the current CEO of a large listed global healthcare leader. Arthur Higgins knows the mechanics of leading a pharmaceutical company inside out, and he has extensive deal making experience. On top of that, they are amazing people, who I am sure will deliver substantial value to UNION.”

Gitte Aabo is the Chief Executive Officer at GN Hearing (NASDAQ: GN), one of the global leaders in hearing aid innovation. Prior to this, she was President & Chief Executive Officer of LEO Pharma. Gitte Aabo is also a member of the Committee of Directors of Danmarks Nationalbank (the Danish National Bank), and a board member of ALK-Abelló A/S and HIMPP A/S. Gitte Aabo has extensive global leadership experience from the life science industry and a deep understanding of dermatology, marketing and capital markets. Gitte Aabo holds an M.Sc. in Business administration from Copenhagen Business School.

Arthur Higgins is a Senior Advisor to Blackstone Private Equity Group and Board member at Ecolab (NYSE: ECL) and Zimmer Biomet (NYSE: ZBH). Previously, Arthur Higgins was Chief Executive Officer of Bayer HealthCare AG as well as Chairman of the Bayer HealthCare Executive Committee and Enzon Pharmaceuticals. He also served as President and Chief Executive Officer and a member of the board of directors of Assertio Therapeutics, Inc. Through extensive leadership experience at large healthcare companies in both the United States and Europe, Arthur Higgins will provide UNION with deep knowledge of the global pharmaceutical markets and strategies for developing, marketing and transacting pharmaceutical products. Arthur Higgins holds a B.Sc. in Biochemistry from Strathclyde University and is based in the U.S.

Contacts
UNION therapeutics A/S

Morten Boesen, Chief Financial Officer
+45 2381 5487 – [email protected]

Media enquiries
Point Communications

Jørgen Fischer Ravn
+45 2030 3903 – j[email protected]

About UNION therapeutics
UNION therapeutics is a privately held, multi-asset, clinical stage pharmaceutical company focused on immunology and infectious diseases. The company currently has seven programs in clinical development. UNION is headquartered in Hellerup, Denmark, and is led by an international team combining biotech entrepreneurs and senior pharmaceutical executives, with a track record of developing, launching and commercializing more than fifteen marketed drugs. Read more at www.uniontherapeutics.com

 

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