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  • Multi-national, double-blinded, and vehicle-controlled study
  • Study expected to enroll approximately 210 patients
  • Topline results expected in Q3 2020

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. Topline data is expected in Q3 2020.

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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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", 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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UNION therapeutics A/S (“UNION”), a privately held, clinical stage, pharmaceutical company targeting inflammatory and microbiome-related disorders, today announced results from two positive Phase 2 studies with its lead compound ATx201 in atopic dermatitis.

Two studies were conducted in patients with atopic dermatitis, an inflammatory skin disease, examining the novel and dual mechanisms of action of ATx201, where the UNION team had identified the compound to have as well anti-inflammatory as anti-bacterial properties.

The “DECOLAD” (ATx201-004) study successfully confirmed the ability of ATx201 to decolonize Staphylococcus aureus in the lesions of 36 patients with atopic dermatitis while seeing a restoration of the healthy skin microbiome. The latter effect was demonstrated through advanced microbiome analysis, showing an increase of the microbial diversity on the skin of the patients, supporting the use of ATx201 to address atopic dermatitis via modulation of the skin microbiome. The #002 study is believed to be the largest microbiome intervention study in atopic dermatitis patients ever conducted to date.

Study ATx201-003 was conducted in 31 patients with atopic dermatitis, examining the anti-inflammatory properties of ATx201. The study demonstrated a broad anti-inflammatory effect on a range of biomarkers affecting core elements of the disease pathology.

Dr. Morten Sommer, Chief Scientific Officer, concluded on the studies: “The findings in atopic dermatitis patients are truly remarkable, and plays directly to the latest research on the disease, including the growing understanding of the multifaceted etiology and pathology”.

Dr. Rasmus Toft-Kehler, Chief Executive Officer, continued: “Combined with the already successfully completed safety studies, these studies offer the prospects of ATx201 as a completely new treatment paradigm for atopic dermatitis, breaking the trade-off between efficacy and safety/tolerability that characterizes current standard of care.”

“We were also very excited to see that the biomarker profile of ATx201 indicates it to have potential for a range of other inflammatory skin diseases with significant unmet medical needs. The spectrum of opportunities will be considered for continued development of ATx201”, continued Dr. Sommer.

A clinical study (ATx201-004) was also conducted to test ATx201 as a potential treatment of impetigo, a superficial bacterial skin infection. But following the positive results in atopic dermatitis and the significant medical need here, it has been decided to focus on atopic dermatitis for near-term clinical development.


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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UNION, a privately held, clinical stage, pharmaceutical company targeting inflammatory and microbiome-related disorders today announced a partnership between Brown University, Rhode Island Hospital and UNION to join forces in the development of a new treatment for Helicobacter pylori. Morten Sommer, CSO at UNION, commented “We are honored and excited to be working with Professor Mylonakis and his group from Brown University to develop a new treatment with great prospects for patients across the world”

H. pylori is one of the world’s most prevalent pathogens and unless treated, colonization usually has lifelong persistence. Most people with H. pylori colonization never experience symptoms, however, each year millions colonized with H. pylori develop gastrointestinal diseases which are also linked to cancer and mortality. Unfortunately, the increase in antibiotic resistance is reducing effective treatment options, hence highlighting the need for new microbiome sparing alternatives.

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.

Continue reading

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