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UNION therapeutics Announces Successful Phase 1 Study Completion with ATx201

UNION, a privately held, clinical stage, pharmaceutical company targeting inflammatory and microbiome-related disorders, today announced positive results from a Phase 1 Sensitization Study in 240 healthy adult volunteers with ATx201. The study was conducted in the US under IND as a randomized and placebo-controlled study. In comparing the active group to placebo, no signs of sensitization were observed, and no subjects showed any signs of unexpected adverse events.

Dr. Philippe Prokocimer, Chief Medical Officer of UNION commented: "The positive outcome of the sensitization study complements prior safety studies with ATx201, in both animals and humans. We are pleased that the studies support the safety and tolerability of ATx201 in both healthy and abraded skin".

Dr. Morten Sommer, the Chief Scientific Officer further added: “The safety and tolerability of ATx201 is of paramount importance given our focus on atopic dermatitis which is common in children. We express our genuine appreciation to the volunteers whose time and effort are helping the development of a much needed new treatment option”. ATx201 is currently being tested in atopic dermatitis patients, for which results are soon expected”.

UNION has previously completed two other Phase 1 studies with ATx201. One of them evaluated the ATx201 irritation potential in 36 healthy adult volunteers. All treatment regimens came out with positive results in both intact and abraded skin after daily applications for 21 days. The other Phase 1 study assessed the systemic safety, local tolerability of three dermal formulations of ATx201 in 30 healthy volunteers using a split-body design. The volunteers were treated twice daily with either ATx201 or placebo during a 7-day period. This study also demonstrated good safety as well as low systemic absorption of ATx201.

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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AntibioTx Announces Company Name Change to UNION therapeutics

Dr. Rasmus Toft-Kehler, Chief Executive Officer of AntibioTx, announced this week in Copenhagen that the company has officially changed its name to UNION therapeutics as of October 5, 2018.

”The new company name – UNION – reflects recent progress on the technology platform and expansion of expertise”, explained Dr. Toft-Kehler, and commented: “Our chemistry platform has provided compounds with very interesting immunological properties in combination with antimicrobial activity. The unique properties of our compounds will enable us to develop innovative treatments across a broad spectrum of diseases” and further adds “the expansion into immunology represents a new era for the company with great prospects for both patients and society”.

UNION is a privately held, clinical stage, pharmaceutical company dedicated to the development of molecules exhibiting both antimicrobial and immunomodulatory effects. UNION will initially focus on the treatment of inflammatory skin diseases, however, the chemistry platform and its versatile new modes of action is expected to be applicable across a wide range of diseases. The leadership team of UNION has invented and successfully developed more than 10 FDA-approved medicines. In 2017, these medicines saved thousands of lives and generated revenues of more than 5 Billion USD. UNION is headquartered in Copenhagen (Denmark) with a US subsidiary and a global team.

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 therapeutic 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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AntibioTx Signs 150 M DKK Financing Agreement with the European Investment Bank

COPENHAGEN, OCTOBER 26, 2017 - AntibioTx A/S has signed a 150 M DKK (20 M EUR) financing agreement with the European Investment Bank to support late-stage clinical trials for the lead candidate ATx201. ATx201 represents a new class of antibiotics with a novel mode of action and is being developed as an innovative treatment for bacterial skin infections.

The financing agreement is supported by InnovFin - a joint initiative of the European Investment Bank and the European Commission to finance innovative healthcare projects. The financial support recognizes recent progress in AntibioTx and the potential value of the platform to respond to the immense threat from antibiotic resistance posed on global public health.

The AntibioTx platform comprises both short and long-term opportunities at the intersection of microbiology and immunology. In 2017 AntibioTx successfully completed the first clinical study and is currently conducting another five clinical studies in Phase I and Phase II on lead candidates. Data from these studies are expected in 2018.

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 AntibioTx 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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AntibioTx Signs Dr. Philippe Prokocimer as Chief Medical Officer and Establishes US Subsidiary

AntibioTx, a clinical stage, pharmaceutical company targeting microbiome-related disorders, has announced the appointment of Dr. Phillipe Prokocimer as new Chief Medical Officer. Dr. Prokocimer brings more than 30 years of experience within antimicrobial drug development and has been involved in successful FDA approval of 6 New Drug Applications including 5 antibacterial compounds: Doripenem (Doribax®), Quinupristin/dalfopristin (Synercid®), Sparfloxacin (Zagam®), Clarithromycin (Biaxin®) and Tedizolid Phosphate (Sivextros®). Dr. Prokocimer will join as a full-time Chief Medical Officer for AntibioTx and lead the clinical development team.

The CEO of AntibioTx, Rasmus Toft-Kehler, commented: “Dr. Prokocimer’s experience and track record in clinical development is exceptional and of significant importance to AntibioTx”, and further added; ”Dr. Prokocimer joins the company at an exciting time and will be playing a key role in the design and execution of upcoming Phase II trials”.

Dr. Prokocimer has been the Chief Medical Officer of Trius Therapeutics from 2007 until its acquisition by Cubist in 2014. Here he was appointed Senior Vice President of Clinical Development at Cubist until it was acquired by Merck in 2015. At Merck, he kept a position as Senior Vice President of Clinical Development as Head of the San Diego site. Dr. Prokocimer received his medical degree from the School of Medicine in Paris, France and a Post-Doctoral Research Fellowship from Stanford University.

The appointment of Dr. Prokocimer is well aligned with the company’s strategy to expand its US presence. AntibioTx recently established a US subsidiary and seeks to build a clinical development team with a basis in San Diego, California.

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 AntibioTx 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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