Tübingen and Frankfurt, Germany, October 18, 2022 – Today, Atriva Therapeutics GmbH, a biopharmaceutical company pioneering the development of host-targeting antiviral therapies, announced three key appointments in their science and clinical development departments. Nigel Horscroft, D.Phil., as CSO, is now in charge of spearheading the company’s scientific evolution. Furthermore, Stephan Witte, Ph.D., Vice President Clinical Science and Operations, and Tim Overend, Ph.D., Vice President Clinical Development and Regulatory, are strengthening the Clinical Development Team in preparation of planned future development programs and clinical studies.

The addition of these experienced leaders is a logical next step in the expansion of in-house capabilities in response to the latest positive results of Atriva’s Proof of Concept / Phase 2a study RESPIRE. This study on the treatment of hospitalized patients with COVID-19 , provided solid data supporting the clinical benefit and favorable safety profile of Atriva’s drug candidate zapnometinib. With these appointments, the company is positioning itself for the next step in clinical development of zapnometinib with a pandemic preparedness Phase 2 study (PanTher). The study is planned to start in 2023 and will include patients with severe viral disease caused by influenzavirus, SARS-CoV-2 or respiratory syncytial virus (RSV).

Nigel Horscroft, CSO of Atriva Therapeutics, is a scientist with over 20 years of industry experience, which he gained at Pfizer, Pike Pharma, CureVac and MRM Health. He is well versed in building and maintaining internal and external partnerships to advance scientific ideas as a team, while drawing on personal expertise and team leadership skills. He has an exceptionally broad background in molecular and cellular biology, pharmacology, virology, biochemistry and immunology and finished his doctorate in biochemistry at the University of Oxford. Nigel Horscroft succeeds founding CSO Prof. Oliver Planz, Ph.D., who is now chairing the Scientific Advisory Board.

Dr. Rainer Lichtenberger, CEO of Atriva Therapeutics, said: “We warmly welcome Nigel to the Atriva team and are pleased to have him on board. Nigel brings many years of significant complementary technical and leadership experience in the research and development of innovative antiviral and immunological therapies. With his expertise and know-how Atriva is well placed to advance our innovative research and early development programs in the coming years. Nigel’s highly relevant experience will perfectly complement and expand the skills and knowledge base of our executive team and our expert scientists.”

“I am delighted to welcome Stephan and Tim to our Atriva clinical development team,” said Dr. Stephan Stenglein, Chief Medical Officer (CMO). “Stephan is an experienced drug developer with more than 20 years of experience in all phases of clinical development and regulatory interactions in both biotech and pharmaceutical companies. Tim is a skilled scientist who brings 25 years of experience in the pharmaceutical industry and in regulatory approval processes, as well as valuable insights from his previous work in respiratory diseases,” Stenglein added. “The addition of Stephan and Tim will further strengthen Atriva to achieve our goals in providing host-targeting antiviral therapies that are not prone to developing viral resistance and could thereby become a major cornerstone of pandemic preparedness.”

Before joining Atriva, Stephan Witte, Ph.D., was Head of Clinical Development and Regulatory Affairs at Inotrem and Vice President Clinical Trials at Breath Therapeutics and was Cofounder and managing director of Akesion GmbH. He also is the owner of Helion Pharma, a drug development and registration consultancy. Apart from clinical Science, Dr. Witte is responsible for Biometrics, Clinical Project Management and Drug Safety/Pharmacovigilance. Stephan Witte received his Ph.D. in biochemistry and immunology from the University of Konstanz, Germany, and completed post-graduate studies in Pharmaceutical Medicine at the University of Basel, Switzerland.

Prior to joining Atriva Therapeutics, Tim Overend, Ph.D., held senior global Clinical Development and Regulatory Affairs positions in respiratory therapeutics at Novartis, Mundipharma and AstraZeneca. Dr. Overend’s primary responsibility will be the development of innovative regulatory strategies to support the rapid global approval of zapnometinib. He will also be responsible for leading a team of Regulatory Specialists, Medical Writers, and Data Managers. Tim Overend received his Ph.D. in Respiratory Physiology and Pharmacology from Liverpool John Moores University, UK.

Both executives will report directly to Dr. Stephan Stenglein, CMO of Atriva Therapeutics.

About the RESPIRE study

RESPIRE1 is a randomized, double-blind, placebo-controlled, international, multi-center POC (Proof of Concept) / Phase 2 clinical trial in adult patients with moderate-to-severe COVID-19. Hospitalized patients with or without supplemental oxygen at the time of screening or randomization were enrolled. On top of standard of care, patients were randomized to receive zapnometinib (ATR-002) 900 mg tablets, once daily on Day 1, followed by zapnometinib 600 mg once daily on Days 2 to 6, or to receive placebo in a matching scheme.

The study is designed to establish the efficacy of zapnometinib; the primary endpoint is CSS on Day 15, using a seven-point ordinal scale as recommended by the WHO COVID-19 Therapeutic Trial Synopsis.2 Secondary endpoints include time to hospital discharge, changes in clinical signs and symptoms and other relevant clinical parameters. All patients have been followed-up for 90 days.

About zapnometinib

The Atriva lead product zapnometinib (ATR-002) was specifically developed to treat diseases caused by RNA viruses, such as influenza and COVID-19. Zapnometinib is a MEK inhibitor targeting the intracellular Raf/MEK/ERK signaling pathway. Many RNA viruses need to activate this pathway to ensure replication, including influenza viruses,3 hantaviruses,4 the respiratory syncytial virus (RSV), 4 and coronaviruses,4 including SARS-CoV-2. Zapnometinib inhibits cellular MEK (MAPK/ERK kinase), blocking the formation of functional virus particles in the host cell, ultimately reducing the viral load in the body.5,6 In SARS-CoV-2 infected cells, inhibition of MEK1/2 by zapnometinib significantly reduces virus production.7

In addition, zapnometinib has the potential to modulate the host immune response and avoid an excessive cytokine/chemokine response that can be caused by viral infections.8,9 This second host-targeting effect may therefore mitigate the overactive inflammatory response, e.g., as seen in the lungs of patients who are severely ill with COVID-19 or influenza.7,10 In SARS-CoV-2 infected cells, inhibition of MEK1/2 by zapnometinib significantly impairs proinflammatory cytokine production.7 Zapnometinib is under advanced clinical development as a treatment for patients with influenza or COVID-19. For the treatment of hantavirus infections, zapnometinib has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA).

About Atriva Therapeutics

Atriva Therapeutics’ mission is to develop an antiviral therapy platform against severe respiratory and systemic diseases with a high unmet medical need induced by RNA viruses, e.g., influenza and COVID-19. The clinical-stage biopharmaceutical company is pioneering the development of host-targeting antiviral therapies, making development of viral resistance unlikely, and thereby significantly contributing to pandemic preparedness. The Atriva lead product zapnometinib (ATR-002) is a first-in-class, host-targeting agent that aims to inhibit viral replication and to favorably modulate the body’s immune response to RNA viruses. Atriva Therapeutics was founded in 2015 by a team of leading scientists in viral research and seasoned industry experts.

Atriva is a founding member of the BEAT-COV initiative. www.beat-cov.de

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