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  • Niclosamide has been identified as a potent inhibitor of SARS-Cov-2 by Institut Pasteur Korea, with potency >40x higher than remdesivir
  • UNION has leveraged existing deep knowledge of niclosamide, derivatives and formulation technologies to rapidly advance a treatment candidate for COVID-19
  • The Danish Medicines Agency has approved UNIONs Clinical Trial Application to initiate study with niclosamide in healthy volunteers
  • The COVID-19 program has been awarded financial support from the Innovation Fund Denmark


COPENHAGEN, Denmark: UNION therapeutics A/S (“UNION”), a privately held clinical stage pharmaceutical company dedicated to the discovery and development of novel medicines for patients with unmet medical needs in inflammatory and infectious diseases, announced this morning that the Danish Medicines Agency has approved initiation of a clinical study with an optimized salt form of niclosamide as a new treatment candidate for COVID-19.

Chief Medical Officer of UNION, Dr Philippe Andres states: “The approval of our Clinical Trial Application is a major milestone, enabling us to further assess the safety and tolerability profile of UNI911 which has the potential to be a uniquely differentiated treatment candidate for COVID-19”.

Over a number of years, UNION has built a deep understanding of niclosamide and its mechanism of action. Professor Morten Sommer, Chief Scientific Officer and Co-founder of UNION, explains: “Niclosamide is a truly differentiated candidate for the treatment of COVID-19, with its method of action, effectively blocking replication of SARS-CoV-2 by targeting host cells to disrupt the viral life cycle. The extensive experience and data generated to date by UNION with niclosamide, and in particular optimized salt forms thereof, have enabled rapid progress leading to the successful approval of the Clinical Trial Application”.

CEO and Co-founder of UNION, Dr. Rasmus Toft-Kehler concludes: “UNION has been through an amazing period of process leading to approval of the Clinical Trial Application. The team, including all stakeholders, partners, physicians, Innovation Fund Denmark, The European Investment Bank, global organizations, investors and not least regulatory authorities, have acted with passion and in concert to advance UNI911 at an incredible pace. We are honored to be part of this venture and excited to be at the cusp of initiating clinical studies with the ultimate goal of making a differentiated product available for patients in need”.

UNION is conducting the first human study at the Zelo Phase I Unit at Bispebjerg and Frederiksberg Hopsital as well as Center for Physical Activity Research 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: info@uniontherapeutics.com      

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 a versatile new mode-of-action chemistry platform, including well-characterized compounds as well as new chemical entities. The leadership team of UNION has successfully developed multiple approved drugs. UNION is headquartered in Copenhagen (Denmark) and managed by an experienced team across Europe and the USA. UNION has received financial support from the European Investment Bank’s InnovFin program under Horizon 2020. Visit the Company’s website at https://uniontherapeutics.com

About niclosamide
Niclosamide is approved as an oral anthelmintic. UNION has been working with niclosamide and the related chemical class for over six years and is currently conducting a Phase 2b study with niclosamide in atopic dermatitis patients. The Company has built extensive knowledge and intellectual property rights around the compound class, formulations and various methods of delivery as well as broadening the pipeline to cover additional diseases within inflammatory and infectious diseases.

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.

This press release contains forward-looking statements. Forward-looking statements are statements that are not historical facts and can be identified by words such as committed, will, steps, may, can, portfolio, planned, advancing, look forward, expected, or similar words. These forward-looking statements are based upon current expectations, estimates, believed potentials and can, therefore, involve risks and uncertainties. Many of these risks and uncertainties can be difficult to predict and could be out of the control of UNION therapeutics A/S. We may not actually achieve our intended plans, and you should not place undue reliance on these forward-looking statements

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  • Niclosamide identified as the most potent FDA approved inhibitor of SARS-Cov-2 by Institut Pasteur Korea
  • Potency of niclosamide >25x higher than chloroquine and >40x higher than remdesivir
  • UNION has extensive knowledge with niclosamide and formulation technology to be deployed in a new potential treatment of COVID-19
  • COVID-19 development program being prepared for submission to the Danish medical authorities

COPENHAGEN, Denmark: UNION therapeutics A/S (“UNION”), a privately held clinical stage pharmaceutical company dedicated to the discovery and development of novel medicines for patients with unmet medical needs in inflammatory and infectious diseases, today announced the launch of a program to test an optimized salt form of niclosamide as a treatment of COVID-19, in collaboration with Institut Pasteur Korea.

Researchers at Institut Pasteur Korea, an infectious disease-focused research institute, have identified niclosamide as the most potent FDA approved inhibitor of SARS-Cov-2 (the virus causing COVID-19) based on in vitro studies, while also having superior potency to the leading programs in development (e.g. remdesivir by Gilead and chloroquine) by 25-40-fold*.

Dr. Wang-Shick Ryu, CEO of Institut Pasteur Korea, states: “I am glad that our experimental finding on the antiviral effect of niclosamide can be immediately translated into COVID-19 therapy. I am impressed by the fact that UNION therapeutics is moving so quickly towards clinical development. It is our hope that the novel formulation ofniclosamide could help to contain the COVID-19 outbreak.”

UNION has worked with niclosamide and the related chemical class for more than five years and is currently conducting a Phase 2b study with niclosamide in atopic dermatitis patients. In recent years, UNION has built extensive knowledge and intellectual property rights around the compound class, formulations and various methods of delivery as well as broadening the pipeline to cover additional diseases within inflammation and infection.

Professor and CSO and co-founder at UNION, Morten Sommer states: “The data from Institut Pasteur Korea confirmed the anti-viral potency of niclosamide in the context of SARS-CoV-2. Combined with our knowledge about the compound’s features, mechanism of action, and favorable safety profile, we consider it to be a promising candidate for treating COVID-19, and believe we can leverage our existing data for an accelerated development program”.

Professor Jutta Heim, Board member of UNION and member of the scientific advisory committee of GARDP, founded by WHO and DNDi, concludes: “The biotech and pharmaceutical industry needs to stand together in their response to this urgent crisis. Accordingly, I am very pleased that UNION can contribute with what I consider a unique and promising program for potential treatment of COVID-19”.

UNION is working towards a submission of the development program to the regulatory authorities.

For inquiries contact:
UNION therapeutics: Morten Boesen, +45 2381 5487 / info@uniontherapeutics.com

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

About Institut Pasteur Korea:
Institut Pasteur Korea (IPK) is an international infectious disease-focused research institute dedicated to address global health issues with a combination of cutting-edge approaches in order to understand disease mechanisms and develop new treatments. By promoting multi-disciplinary projects, IPK is at the forefront of drug discovery and contributes to Korea’s future scientific resources through research, education and technological innovation. IPK is a private, non-profit foundation with four core missions of public interest – Research, Education, Public Health, and Translation of biomedical discoveries to improve health via technology transfer and industrial partnerships.

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 of a versatile new mode-of-action chemistry platform, including well-characterized compounds as well as new chemical entities. The leadership team of UNION has successfully developed multiple approved drugs on the market. UNION is headquartered in Copenhagen (Denmark) and managed by an experienced team across Europe and USA.

This press release contains forward-looking statements. Forward-looking statements are statements that are not historical facts and can be identified by words such as committed, will, steps, may, can, portfolio, planned, advancing, look forward, expected, or similar words. These forward-looking statements are based upon current expectations, estimates, believed potentials and can, therefore, involve risks and uncertainties. Many of these risks and uncertainties can be difficult to predict and could be out of the control of UNION therapeutics A/S. We may not actually achieve our intended plans, and you should not place undue reliance on these forward-looking statements

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  • Multi-national, double-blinded, and vehicle-controlled study
  • Study expected to enroll approximately 210 patients

COPENHAGEN, Denmark: UNION therapeutics A/S (“UNION”), a privately held clinical stage pharmaceutical company dedicated to the discovery and development of novel medicines for patients with unmet medical needs in inflammatory and infectious diseases, today announced the First Patient First Visit in a Phase 2b dose-ranging study evaluating the safety and efficacy of ATx201 OINTMENT in adult and adolescent patients with mild-to-moderate atopic dermatitis.

“Atopic dermatitis is a debilitating disease affecting the lives of millions of patients and their families. Despite it being the most common form of eczema, the current treatments continue to be characterized by a trade-off between efficacy and safety. We hope to be able to break this trade-off with ATx201 OINTMENT, and believe it could become a new mainstay treatment for atopic dermatitis”, states Rasmus Toft-Kehler, CEO of UNION.

“The mechanism of action of ATx201 is novel, making it a new class of treatment for inflammatory diseases and differentiating it from the products on the market as well as in development. Our initial clinical and preclinical studies have generated support for the mechanism of action to be well suited for treatment of atopic dermatitis. We are therefore very excited to initiate this study as an important step towards helping the many patients with atopic dermatitis”, states Professor Morten Sommer, Chief Scientific Officer of UNION.

“Despite positive advancements in recent years, the medical need for new treatment solutions for atopic dermatitis is very significant, and I look forward to seeing the data for ATx201”, says Jacob Thyssen, Clinical Professor in Dermatology at Copenhagen University and Herlev-Gentofte Hospital, and Principal Investigator in Denmark on the study.

ATx201 Phase 2b study
The randomized, double-blinded, vehicle-controlled, parallel group Phase 2b study is designed to evaluate the safety and efficacy of ATx201 OINTMENT as a monotherapy and to establish the dosing regimen for a potential Phase 3 program in patients with mild-to-moderate atopic dermatitis. The study is expected to enroll approximately 210 patients aged 12 years and older with mild-to-moderate atopic dermatitis. The study is conducted at sites in three countries in the European Union. The study will evaluate two active treatment groups compared to a placebo (vehicle) treatment group for 6 weeks, with patients randomized in a 1:1:1 fashion:

  • Treatment group 1: Twice-daily treatment with 4% ATx201 OINTMENT
  • Treatment group 2: Twice-daily treatment with 7% ATx201 OINTMENT
  • Treatment group 3: Twice-daily treatment with placebo (vehicle)

The primary end-point of the study is the mean change in Eczema Area Severity Index (EASI) from baseline to week 6. Secondary end-points include a number of other efficacy measures as well as patient reported outcomes.

About UNION:
UNION is a privately held, clinical stage, pharmaceutical company dedicated to the development of novel treatments for inflammatory and infectious diseases. The company is working of a versatile new mode-of-action chemistry platform. The leadership team of UNION has successfully developed multiple approved drugs on the market. UNION is headquartered in Copenhagen (Denmark) and managed by a global team across Europe and USA.

This press release contains forward-looking statements. Forward-looking statements are statements that are not historical facts and can be identified by words such as committed, will, steps, may, can, portfolio, planned, advancing, look forward, expected, or similar words. These forward-looking statements are based upon current expectations, estimates, believed potentials and can, therefore, involve risks and uncertainties. Many of these risks and uncertainties can be difficult to predict and could be out of the control of UNION therapeutics A/S. We may not actually achieve our intended plans, and you should not place undue reliance on these forward-looking statements

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Copenhagen, Denmark: UNION therapeutics A/S announced today that a milestone was achieved in its UNI836 collaboration with Ceva Santé Animale S.A. The milestone was triggered by confirmation from Ceva of successful completion of a clinical efficacy study of UNI836 in canine pyoderma.

“We are pleased with the results generated by Ceva. Not only do they confirm the potential of UNI836 in canine pyoderma, providing an innovative approach to an unmet medical need in veterinary care, but the data also provide strong support for the chemistry platform in human health”, states Dr. Morten Sommer, Chief Scientific Officer of UNION, and continues: “We look forward to advancing the collaboration with Ceva, and to further elucidate the potential of the platform across a broader spectrum of indications.”

Achievement of the milestone has triggered an undisclosed milestone payment to UNION.

About UNION:
UNION is a privately held, clinical stage, pharmaceutical company dedicated to the development of molecules exhibiting both antimicrobial and immunomodulatory effects. The leadership team of UNION has invented and successfully developed multiple approved human medicines. UNION is headquartered in Copenhagen (Denmark) and managed by a global team across Europe and USA.

About CEVA:
Ceva Santé Animale is a global veterinary health company focused on the research, development, production and marketing of pharmaceutical products and vaccines for companion animals, livestock, swine and poultry. Ceva’s mission summarised in the slogan, "Together, beyond animal health" recognises that the future health of animals, humans and our planet are inseparably bound together. Ceva is directly present in 45 countries around the world and have active business in over 110.

This press release contains forward-looking statements. Forward-looking statements are statements that are not historical facts and can be identified by words such as committed, will, steps, may, can, portfolio, planned, advancing, look forward, expected, or similar words. These forward-looking statements are based upon current expectations, estimates, believed potentials and can, therefore, involve risks and uncertainties. Many of these risks and uncertainties can be difficult to predict and could be out of the control of UNION therapeutics A/S. We may not actually achieve our intended plans, and you should not place undue reliance on these forward-looking statements.

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COPENHAGEN, FEBRUARY 7, 2019 - UNION therapeutics A/S (UNION) today announced that it has entered into a strategic veterinary partnership with Ceva Santé Animale S.A. (Ceva) on the candidate UNI836.

Under the agreement, Ceva will be developing UNI836 for treatment of canine pyoderma. Canine pyoderma is one of the most frequent diseases in companion animals and a significant burden for both animal patients and their owners.

Chief Executive Officer of UNION, Dr. Rasmus Toft-Kehler, commented: “We appreciate to be collaborating with one of the fastest growing veterinary care companies on broadening the utility of the compound class. The results generated in collaboration with Ceva indicates that UNI836 has the potential to become a new and highly innovative treatment for companion animals and their owners”. Dr. Morten Sommer, Chief Scientific Officer of UNION, further commented: “Our collaborative efforts have highlighted the novel mechanism of action underlying UNI836 to provide an interesting approach to tackle an unmet medical need in the veterinary space. We look forward to continue working with Ceva on the advancement of UNI836 for treatment of canine pyoderma”.

Dr. Pascal Anjot, VP Global R&D & Innovation, Ceva added: "We are very pleased to be associated with UNION therapeutics for the development of this new opportunity in the treatment of Pyoderma in companion animals. Ceva has long been at the forefront of promoting the rational use of antibiotics in veterinary medicine. The GRAM (Guidance for the Rational use of Antimicrobials) initiative developed together with leading European experts is a good example and this new project with UNION offers to provide veterinarians with a very innovative, therapeutic approach to the treatment of this condition, in line with this aim of continually developing best practice".

As part of the agreement, Ceva will be taking responsibility for further development and global commercialization of UNI836.

About UNION:
UNION is a privately held, clinical stage, pharmaceutical company dedicated to the development of molecules exhibiting both antimicrobial and immunomodulatory effects. The leadership team of UNION has invented and successfully developed more than 10 approved human medicines. In 2018, these medicines saved thousands of lives and generated revenues of more than 5 Billion USD. UNION is headquartered in Copenhagen (Denmark) and managed by a global team across Europe and USA.

About CEVA:
Ceva Santé Animale is a global veterinary health company focused on the research, development, production and marketing of pharmaceutical products and vaccines for companion animals, livestock, swine and poultry. Ceva’s mission summarised in the slogan, "Together, beyond animal health", This document is strictly confidential and not intended for circulation or publication, nor is it to be used, 2 or distributed without prior written consent of UNION therapeutics A/S. Violations may be legally prosecuted. recognises that the future health of animals, humans and our planet are inseparably bound together. Ceva is directly present in 45 countries around the world and have active business in over 110.

This press release contains forward-looking statements. Forward-looking statements are statements that are not historical facts and can be identified by words such as committed, will, steps, may, can, portfolio, planned, advancing, look forward, expected, or similar words. These forward-looking statements are based upon current expectations, estimates, believed potentials and can, therefore, involve risks and uncertainties. Many of these risks and uncertainties can be difficult to predict and could be out of the control of UNION therapeutics A/S. We may not actually achieve our intended plans, and you should not place undue reliance on these forward-looking statements.

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