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Algiax Pharmaceuticals Announces New Executive Team and Clinical Trial Plan for Lead Candidate AP-325

Algiax Pharmaceuticals Appoints Dr. Ingo Lehrke and Dr. Guido Koopmans as CEO and CSO. A Proof-of-Concept Study for Neuropathic Pain is planned to start in Q4 2019.

Düsseldorf, Germany; May 6, 2019 – Algiax Pharmaceuticals, a clinical-stage biotechnology company focused on development of GABAAreceptor modulators for neuropathic pain and other indications with unmet medical need, announced the appointment of Dr. Ingo Lehrke as CEO and Dr. Guido Koopmans as CSO, effective May 1, 2019.

Dr. Lehrke takes over from co-founder and shareholder Dr. Jürgen Schumacher who becomes chairman of Algiax´ new advisory board. “I am very happy to have Ingo join and lead our executive team” said Jürgen Schumacher. “He is an experienced pharma manager and has successfully developed and partnered a novel pain drug prior to joining Algiax. I believe that his knowledge will create high added value for the further development of our lead candidate AP-325.”

Dr. Lehrke served for the last ten years as Managing Director of tesa Labtec GmbH, a drug delivery company that is part of the Beiersdorf Group of companies. Before that he was managing director and shareholder of Labtec GmbH which was acquired by tesa SE in 2008.Dr. Koopmans is neuroscientist and holds a PhD in Biological Health Science. He co-founded Algiax Pharmaceuticals and developed AP-325 from bench to bedside.

The company further announced that it intends to start a phase IIa clinical study for its lead candidate AP-325 in chronic neuropathic pain. “We are excited to initiate the next development stage of AP-325 with the goal to show its proof-of-concept in patients, soon” said Dr. Koopmans. “We plan to have the first patient included in the fourth quarter of this year and expect first results in 2020”

New Center of Competence for Innovative Diabetes Therapy (KomIT) is funded by NRW and EU

Algiax Pharmaceuticals is founding partner of the new Center of Competence for Innovative Diabetes Therapy (KomIT) funded by NRW and EU

March 27, 2019, Erkrath, Germany– Algiax Pharmaceuticals is part of a new consortium of eight partners from industry and academia focusing on the development of new diabetes therapies. During the next three years, a new Center of Competence will be established at the German Diabetes Center (DDZ) based on a total funding of about 3.5 Mio Euro provided by Northrhine-Westphalia and the EU. This center is coordinated by DDZ and aims at efficient translation of new research results into clinical application, finally improving therapeutic options for diabetic patients. Algiax has several preclinical drug candidates which have a great potential for further development as a new anti-diabetic therapy.

The continuous rise in the number of diabetic patients in Germany and the associated socio-economic burden for the health system urgently require the development of new causal therapies. “Together with our partners we aim to establish a sustainable infrastructure, to bring innovative approaches of diabetes therapy rapidly and directly to the patients” explains Prof. Michael Roden, scientific Director of the German Diabetes Center and coordinator of the new Center of Competence for Innovative Diabetes Therapy (KomIT). “Our joint activities aim to bundle expertise, finally leading to scientific and technological break-throughs in diabetes research”. In addition to Algiax Pharmaceuticals and DDZ, the other partners are: LDC, Taros Chemicals GmbH & Co. KG, vivo Science GmbH, A & M Labor für Analytik und Metabolismusforschung Service GmbH, PROFIL Institut für Stoffwechselforschung GmbH, and TU Dortmund with the Drug Discovery Hub Dortmund (DDHD).

This novel research infrastructure provides a strong boost for the pharma and biotech sector in Northrhine-Westphalia and supports innovation and competitiveness in NRW. The project is funded within the program “EFRE.NRW – Investitionen in Wachstum und Beschäftigung” supported by NRW and the European Union.

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JDRF funded collaboration with UCLA on Type 1 Diabetes

End of June 2016 Algiax started a collaboration program to perform a preclinical Proof-of-Concept in Diabetes Type 1 with a selection of Algiax` proprietary new chemical entities.

Clinical Phase Ib, Pharmacodynamic effect study

On December 10th 2015 Algiax got its approval from the German authorities (BfArM) to start the Phase Ib study entitled “Pharmacodynamic Effects of AP-325 in Healthy Male Subjects using the Intradermal (ID) Capsaicin and Pressure Pain Models”.

Algiax announces positive data of Clinical Phase I

Today Algiax announces the completion of two successful Phase I trials with their lead compound AP-325. AP-325 was tested in both single and multiple dose studies in healthy volunteers. In the two clinical studies AP-325 was shown to be safe and well tolerated and the aimed exposure levels with the oral formulation have been reached.

Clinical Phase Ia, multiple ascending dose

As of June 2015, Algiax initiated a Phase I study with the primary objective to investigate the pharmacokinetics, safety, and tolerability of multiple ascending doses of AP-325 in healthy male subjects.

Clinical Phase Ia, single dose

As of November 2014, Algiax initiated a Phase I study with the primary objective to investigate the pharmacokinetics, safety, and tolerability of single ascending doses of AP-325 in healthy male subjects. In addition, Algiax aimed to investigate the influence of food, gender and age on the safety, tolerability, and pharmacokinetics of a single oral dose of AP-325.

Orphan Drug Designation

In August 2013 our lead compound AP-325 received Orphan Drug Designation from EMA for the treatment of traumatic spinal cord injury.

Series A investment

In January 2012 a Series A investment of 4.3M€ was closed.

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