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  • Niclosamide is a potent inhibitor of SARS-CoV-2 with potency >40x higher than remdesivir as demonstrated by Institut Pasteur Korea
  • The sinonasal cavity is considered a major site of early infection by SARS-CoV-2 and a major factor in transmission. 
  • Intranasal administration of niclosamide has been demonstrated to prevent fatal outcomes in a murine challenge model
  • UNI91103 is a nasal spray pump delivering a concentrated niclosamide salt solution to the nasal cavity
  • UNI91103 has been tested in 44 healthy volunteers with positive results
  • UNI91103 is being prepared for clinical trials in subjects at high risk of contracting COVID-19


Hellerup, Denmark, October 21, 2020 – UNION therapeutics A/S (UNION) announces expansion of the clinical pipeline with the addition of UNI91103 (intranasal niclosamide) to prevent COVID-19 and reduce the severity of the diseases among those already infected.

An alternative to vaccination in high-risk groups

Several high-risk patient groups do not respond well to vaccination suggesting a persistent need for alternative prophylactic measures. In response, UNION has expanded its clinical program for COVID-19 with a niclosamide based nasal spray (UNI91103) to prevent and alleviate infection among people at risk. UNI91103 will first be investigated in high risk patients to test its ability to prevent infection with COVID-19 and to reduce the severity of the disease for those already infected.

In addition, the nasal spray will be used in the treatment trials in combination with UNION’s inhalation product (UNI91104), which continues development for treatment of COVID-19. The nasal spray product, UNI91103, has been successfully tested in 44 healthy volunteers without significant safety concerns and is ready for tests in COVID-19 patients as well as subjects at risk of contracting COVID-19.

Maximizing the likelihood of prevention and treatment options

“The split of our COVID-19 program into two independent products for treatment and prevention of COVID-19 substantially increases the likelihood of bringing aid to patients and reducing societal impact” says Rasmus Toft-Kehler, CEO and co-founder of UNION.

Niclosamide was recently identified by Institut Pasteur Korea as a potent inhibitor of SARS-CoV-2, the virus causing COVID-191. Furthermore, niclosamide has been demonstrated to prevent fatal outcomes in a murine model of COVID-19 when administered intranasally2.

Studies have documented that SARS-CoV-2 replicates most rapidly in the nasal epithelial cells and suggest that initial replication of the virus in the nasal cavity then leads to infection of the lungs. Sinonasal pathophysiology is increasingly important for our understanding of COVID-19, and the sinonasal tract is thought to be an important site for both infection as well as transmission3.

“The sinonasal cavity is an important site for the establishment and replication of SARS-CoV-2 in the early stages of COVID-19, accordingly we consider delivery of niclosamide directly to this site of early infection a key strategy for limiting the infection of people otherwise at risk for contracting COVID-19,” says UNION co-founder Professor Morten Sommer.

UNION therapeutics expects to commence patient trials using UNI91103 in Q4 2020.

Sources
1. Jeon et al. AAC 2020, DOI: 10.1128/AAC.00819-20
2. Brunaugh et al. BiorXiv 2020, DOI: 10.1101/2020.09.24.310490
3. Gengler et al. Laryngoscope Investig Otolaryngol  2020, DOI: 10.1002/lio2.384

Contact
Morten Boesen
Chief Financial Officer
Phone: +45 2381 5487
Email: info@uniontherapeutics.com
Website: www.uniontherapeutics.com

 

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  • UNION has successfully completed inhalation dosing of 44 healthy volunteers, confirming the safety and tolerability of UNI911
  • UNION has utilized many years of experience with niclosamide to develop UNI911, a proprietary salt form and formulation of niclosamide, for inhalation as a treatment candidate for COVID-19
  • Delivery directly to the lung via inhalation allows UNION to address common challenges related to low bioavailability of oral niclosamide
  • Niclosamide has been identified as a potent inhibitor of SARS-Cov-2 by Institut Pasteur Korea, with potency >40x higher than remdesivir1
  • UNION is preparing to advance UNI911 into COVID-19 patient trials


Hellerup, Denmark, August 25 2020 - UNION therapeutics A/S (“UNION”), a privately held, clinical stage pharmaceutical company, today announces the successful completion of dosing of 44 healthy volunteers with UNI911, an optimized salt form of niclosamide, as an inhalation treatment candidate for COVID-19.

The study was a double-blind, placebo-controlled, randomized study, where ascending single and multiple dosing regimens were given to 44 healthy volunteers by inhalation across five cohorts. The purpose of the study was to confirm the safety of UNI911 in preparation for a study to assess the safety and efficacy in patients with COVID-19.

UNI911 utilizes an optimized salt form of niclosamide, an existing compound identified as a potent inhibitor of SARS-Cov-2 by Institut Pasteur Korea, with potency >40x higher than remdesivir1. Niclosamide has a well-established safety profile as an oral compound following decades of use as an anthelmintic drug. By delivering niclosamide salt form directly to the lungs through inhalation, high local exposures can be achieved and thereby resolve the common challenge of low oral bioavailability linked to niclosamide.

The Safety Monitoring Committee assessed the safety of UNI911 in each cohort before dose escalation in the next cohort was initiated. Successful completion of the five study cohorts provides basis for investigating UNI911 in COVID-19 patients.

“Finding treatment options for COVID-19 is of critical importance for the world, and UNI911 is a very interesting and differentiated candidate. The study confirmed that the drug is safe when administered by inhalation, which is a crucially important step in the development of any medicine. Delivering therapies via inhalation is widely used in respiratory medicine, particularly for the treatment of asthma and Chronic Obstructive Pulmonary Disease (COPD), and delivering niclosamide by this means is looking very promising”, said Dr. Vibeke Backer, Clinical Professor at Rigshospitalet, Chairman of the Safety Monitoring Committee and National Coordinating Investigator on the study.

“Confirming the safety of UNI911 in healthy volunteers is a major milestone achieved in record speed, which has only been possible due to the extraordinary support and dedication of all involved parties. It provides further evidence that UNI911 is a uniquely differentiated candidate for prophylaxis and treatment of COVID-19. The team is now entirely dedicated to moving UNI911 into COVID-19 patients as rapidly as possible”, added Rasmus Toft-Kehler, CEO and co-founder of UNION.

The study in healthy volunteers was conducted in Denmark at the Zelo Phase I Unit at Bispebjerg and Frederiksberg Hospitals as well as Center for Physical Activity Research (CFAS) at Rigshospitalet, in collaboration with Trial Nation Denmark and the Technical University of Denmark, and with financial support from the Innovation Fund Denmark.

Contact
Morten Boesen
Chief Financial Officer
Tel: +45 2381 5487
Email: morten.boesen@uniontherapeutics.com           

JW Communications
Julia Wilson
Tel: +44 781 8430877
Email: communications@uniontherapeutics.com

1 Source: https://www.biorxiv.org/content/10.1101/2020.03.20.999730v2.full.pdf

About UNION:
UNION therapeutics A/S is a privately held, clinical stage, pharmaceutical company dedicated to the development of novel treatments for inflammatory and infectious diseases. The Company is working on two complementary chemistry classes spanning immunology and microbiology and has three candidates in clinical development. UNION is headquartered in Hellerup (Denmark) and managed by an experienced team across Europe and USA. For more information please visit www.uniontherapeutics.com.

About UNI911 (inhaled niclosamide) in COVID-19
Recent studies undertaken by the Institut Pasteur Korea, an infectious disease-focused research institute, have identified niclosamide as one of the most potent inhibitors of SARS-Cov-2; the virus causing COVID-19 based on in vitro studies. Niclosamide has the potential to become a truly differentiated treatment of COVID-19, effectively blocking replication of SARS-CoV-2 by targeting host cells to disrupt the viral life cycle. UNION has more than six years of preclinical and clinical experience with niclosamide and has utilized these insights to advance a battery of potential niclosamide-based treatments for COVID-19. UNI911 is UNION’s lead program based on a proprietary salt form and formulation of niclosamide to be administered by inhalation. By delivering UNI911 directly to the lungs via inhalation addresses the challenges related to low bioavailability of niclosamide administered orally.

 

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  • Niclosamide identified as a potent inhibitor of SARS-Cov-2 by Institut Pasteur Korea, with potency >40x higher than remdesivir
  • UNION has advanced niclosamide-based program for COVID-19 (UNI911) to clinical development, currently in Phase 1 study
  • TFF formulation technology can broaden the possible range of niclosamide formulations and treatments
  • Collaboration between UNION and TFF holds potential to make niclosamide treatments available to a broader range of patients globally


Hellerup, Denmark, August 13 2020 – UNION therapeutics A/S (“UNION”) today announced the completion of an agreement with TFF Pharmaceuticals, Inc. (“TFF”) to acquire an option to obtain a worldwide exclusive license for the use of their Thin Film Freezing technology in combination with niclosamide to focus on treatments for COVID-19.

Niclosamide was recently identified by Institut Pasteur Korea as a potent inhibitor of SARS-CoV-2, the virus causing COVID-191.

For a number of years, UNION has worked with niclosamide as a potential treatment for a range of inflammatory and infectious diseases. The Company is currently conducting a Phase 1 clinical trial of an optimized salt form of the compound developed as a potential inhalation treatment of COVID-19.

Based on research from the University of Texas and its patented formulation technology and expertise, TFF has developed alternative oral and inhalation versions of niclosamide, which are currently being prepared for human studies. Under the agreement, UNION will acquire an option to obtain a worldwide exclusive license to the technology and rights relating to the formulations of niclosamide for the treatment of COVID-19. UNION is already progressing the niclosamide-based product UNI911 through clinic development, and the agreement with TFF has the potential to substantially broaden UNION’s niclosamide product offering.

“Like UNION, TFF has been working with niclosamide for an extended period of time and has taken an interesting approach to the formulation of niclosamide for COVID-19. We are excited to formalize our collaboration with the TFF team and consolidate our joint efforts under the wings of UNION. This will allow us to maximize the likelihood of getting the best possible product to as many COVID-19 patient segments in the shortest possible timeframe,” said Rasmus Toft-Kehler, CEO and co-founder of UNION.

Prof. Morten Sommer, co-founder and CSO of UNION further commented; “We have interacted closely with TFF and have been impressed with their team as well as their formulation technologies, which complement our current niclosamide-programs.”

Under the agreement, UNION will pay TFF up to 210 million USD related to option exercise, development and commercial milestones, as well as tiered single-digit royalties on product sales.


About UNION therapeutics A/S
UNION therapeutics A/S is a privately held, clinical stage, pharmaceutical company dedicated to the development of novel treatments for inflammatory and infectious diseases. The Company is working on two complementary chemistry classes spanning immunology and microbiology and has three candidates in clinical development. UNION is headquartered in Hellerup (Denmark) and managed by an experienced team across Europe and USA. For more information please visit www.uniontherapeutics.com.

About TFF Pharmaceuticals’ Thin Film Freezing technology platform
TFF Pharmaceuticals’ Thin Film Freezing (TFF) platform was designed to improve the solubility and absorption of poorly water-soluble drugs and is particularly suited to generate dry powder particles with properties targeted for inhalation delivery, especially to the deep lung, an area of extreme interest in respiratory medicine. The TFF process results in a “Brittle Matrix Particle,” which possesses low bulk density, high surface area, and typically an amorphous morphology. allowing the particles to supersaturate when contacting the target site, such as lung tissue. Based upon laboratory experiments the aerodynamic properties of the particles are such that the portion of a drug deposited to the deep lung has the potential to reach as high as 75 percent.

About TFF Pharmaceuticals
TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing, or TFF, technology platform. Early testing confirms that the TFF platform can significantly improve the solubility and absorption of poorly water-soluble drugs, a class of drugs that comprises approximately one-third of the major pharmaceuticals worldwide, thereby improving their pharmacokinetics. TFF Pharmaceuticals has two lead drug candidates: Voriconazole Inhalation Powder and Tac-Lac Inhalation Powder. The Company plans to add to this pipeline by collaborating with large pharmaceutical partners. The TFF Platform is protected by 41 patents issued or pending in the US and internationally. To learn more about TFF Pharmaceuticals and its product candidates, visit the Company’s website at https://tffpharma.com.

About niclosamide in COVID-19
Recent studies undertaken by the Institut Pasteur Korea, an infectious disease-focused research institute, have identified niclosamide as one of the most potent inhibitors of SARS-Cov-2; the virus causing COVID-19 based on in vitro studies. Niclosamide has the potential to become a truly differentiated treatment of COVID-19, effectively blocking replication of SARS-CoV-2 by targeting host cells to disrupt the viral life cycle.

Contacts
Morten Boesen
Chief Financial Officer
Tel: +45 2381 5487
Email: info@uniontherapeutics.com                        

JW Communications
Julia Wilson
Tel: +44 781 8430877
Email: communications@uniontherapeutics.com

1 Source: https://www.biorxiv.org/content/10.1101/2020.03.20.999730v2.full.pdf

 

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Hellerup, Denmark: UNION therapeutics A/S today announced the publication of a systematic review and meta-analysis of COVID-19 patient's presence and duration of SARS-CoV-2 virus published in EBioMedicine under The Lancet.

The main findings showed consistent viral detection in the upper respiratory tract (URT), the lower respiratory tract (LRT), and faeces, irrespective of the clinical severity of COVID-19 and that SARS-CoV-2 persists for a longer duration in the LRT compared to the URT in moderate-severe and mild adult patients (p < 0.05). No difference between viral duration between mild and moderate-severe patients LRT. 

These findings may contribute to a better understanding of the pathology of COVID-19 and shed new light on further research and incentives against the Pandemic. 

This study was supported by the Innovation Fund Denmark (No 0208-0081)

For full article, please see: LINK 

 

 

 

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  • Candidates in the LEO PDE4 inhibitor compound series have demonstrated potential to become ‘best-in-class’ based on Phase 2 studies in psoriasis (oral) and atopic dermatitis (topical)
  • PDE4 compound series strengthens UNION’s pipeline and offers potential synergies at organizational, financial and commercial levels

Hellerup, Denmark, July 21, 2020 – UNION therapeutics A/S (“UNION”) today announced the completion of a transaction with LEO Pharma A/S (LEO Pharma) to acquire the global rights for the LEO PDE4 inhibitor compound series to be re-named UNI500.

UNI500 is a series of phosphodiesterase type 4 (PDE4) inhibitors that were discovered by LEO Pharma. LEO Pharma has been developing candidates from this series from discovery into Phase 2 in psoriasis (orismilast, oral) and atopic dermatitis (orismilast, topical) and in both indications demonstrated superior effect over placebo in randomized, double-blinded, placebo-controlled clinical studies.

“The acquisition of the PDE4 inhibitor compound series is perfectly aligned with UNION’s vision to build a sustainable pharmaceutical company and it complements our current clinical activities in immuno-dermatology. The acquisition substantially accelerates our growth trajectory and enables synergies at organizational, financial, and commercial levels. Above and beyond that, UNION considers compounds from the PDE4 inhibitor compound series to have best-in-class potential for the treatment of psoriasis and other immune-dermatological disorders, with an overarching aim to address unmet medical needs”, said Rasmus Toft-Kehler, Chief Executive Officer of UNION.

Morten Sommer, Chief Scientific Officer, of UNION explains “Orismilast has demonstrated promising effects in clinical studies suggesting that it could become an attractive oral treatment option for patients with psoriasis and other immune-dermatological disorders. Our ambition, based on demonstrated potency levels, is to develop orismilast as a best-in-class PDE4 inhibitor across multiple immune-related diseases. As a next step, UNION will finalize formulation efforts with orismilast and simultaneously evaluate priority indications for clinical advancement”.

Thorsten Thormann, Vice President, Global Research at LEO Pharma added “LEO Pharma has been working very closely with the UNION team and have been impressed with their approach and professionalism in dermatological drug development. Accordingly, when the strategic decision was taken to divest the LEO PDE4 inhibitor compound series and orismilast, UNION was an obvious partner of choice for LEO Pharma. We look forward to seeing the program moving forward for the benefit of patients in need of new treatment options”.

Under the agreement, UNION will pay upfront, development and commercial milestones of up to 200 million USD, plus low single-digit royalties on sales. As part of the transaction, LEO Pharma also becomes a minority shareholder in UNION therapeutics.

About UNION therapeutics A/S
UNION therapeutics A/S is a privately held, clinical stage, pharmaceutical company dedicated to the development of novel treatments for inflammatory and infectious diseases. The company is working on two complementary chemistry classes spanning immunology and microbiology and has three candidates in clinical development. UNION is headquartered in Hellerup (Denmark) and managed by an experienced team across Europe and USA.

About LEO Pharma A/S
The company is a leader in medical dermatology with a robust R&D pipeline, a wide range of therapies and a pioneering spirit. Founded in 1908 and owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, setting new standards of care for people with skin conditions. LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 92 million patients in 130 countries.


Contacts
Morten Boesen
Chief Financial Officer
Tel: +45 2381 5487
Email: info@uniontherapeutics.com                        

JW Communications
Julia Wilson
Tel: +44 781 8430877
Email: communications@uniontherapeutics.com

 

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