Atriva Therapeutics to Speed up Development of COVID-19 Drug with Federal Funding

• German Federal Ministry of Education and Research (BMBF) awards Atriva up to €11.4 million for the clinical development of a drug to treat COVID-19
• Product candidate ATR-002 could help hospital patients with COVID-19 avoid ventilation and intensive care treatment
• Targeting RNA viruses and acting in the host cell, drug candidate can retain full activity even with SARS-CoV-2 variants
• Therapeutic aims to inhibit replication of virus and to prevent overshooting immune response
• Tablet can be administered easily

Tübingen (Germany), April 21, 2021 - Atriva Therapeutics GmbH, a company that is pioneering the development of therapies for the treatment of viral infections, has secured up to €11.4 million in federal funding. The company, founded in 2015, announced today that it was selected for research funding from the German Federal Ministry of Education and Research (BMBF). Atriva will use the funds to advance its drug ATR-002 towards market maturity as quickly as possible. "We are delighted our work has been recognised by the panel of experts around Prof. Dr. Ciesek and Dr. Spinner," says Atriva's CEO Dr. Rainer Lichtenberger. The funding is part of a €50 million BMBF programme for COVID-19 therapies, awarded to a total of eight companies.

"The late clinical development stage, the pivotal Phase III trials in particular, and the manufacturing preparations for the drug are very expensive. Finding the respective financing is difficult for small biotech companies," explains Atriva's CEO Dr. Rainer Lichtenberger. "Especially in such a global health crisis as this, a broad public funding initiative is extremely important and can be decisive for speeding up the drug development process - as has been impressively demonstrated with the SARS-CoV-2 vaccines."

ATR-002 is currently in a Phase II clinical study called RESPIRE. It is suitable for COVID-19 patients with moderate to severe symptoms who are hospitalised but do not yet require ventilation or intensive care. The RESPIRE trial aims to evaluate the efficacy and safety of the drug candidate in 220 adults; the first patient was treated in mid-April. A Phase I trial to assess safety and tolerability has already been successfully completed.

The fight against the pandemic not only requires vaccines, but also effective and safe drugs to treat patients suffering from the different stages of COVID-19. "We believe ATR-002 has great potential here because it aims to not only inhibit the replication of the virus but also to prevent an excessive immune response," Lichtenberger says. "This often causes severe progression of the disease." ATR-002 acts in the host cell and is most likely not prone to a loss of effectiveness in virus mutations such as B.117, B.1.315 and P.1.

Should the current clinical trial lead to good results and conditional approval from regulatory authorities, the new funding would help Atriva bring the drug to the patient faster.

About ATR-002's mode of action with dual benefit

Atriva's lead product ATR-002 is developed specifically to treat diseases such as influenza and COVID-19, caused by RNA viruses. ATR-002 is a clinical stage MEK inhibitor drug candidate targeting the intracellular Raf/MEK/ERK signaling pathway. This pathway is central for replication of many RNA viruses, such as the influenza virus, hantavirus or respiratory syncytial virus (RSV) and also SARS-CoV-2, the virus that causes COVID-19. In influenza virus infected cells, the interaction of ATR-002 with MEK (MAPK/ERK kinase) prevents export of the viral genome protein complexes (ribonucleoprotein, RNP) from the nucleus to the cytoplasm, thus blocking the formation of functional new viral particles. This ultimately reduces the viral load in the body. In addition, ATR-002 has the potential to modulate the pro-inflammatory cytokine response of the body, avoiding overshooting cytokine response that can be caused by such viral infections. MEK inhibition can reduce the gene expression of some of the cytokines involved, like TNF-α, IL-1ß, IP-10, IL-8, MCP-1 and MIP-1a, and thus mitigate the overactive inflammatory response in the lungs of patients who are severely ill with influenza or COVID-19.

About Atriva Therapeutics GmbH

Atriva Therapeutics, founded in 2015, is a biopharmaceutical company that is pioneering the development of host-targeting antiviral therapies. It was set up by a team of leading scientists in viral research as well as proven industry experts. The company aims to develop a therapy platform to treat severe respiratory diseases induced by RNA viruses with a high unmet medical need, such as influenza and COVID-19. The Atriva lead product ATR-002 is a first-in-class, host-targeting agent that aims to inhibit viral replication in influenza and to favorably modulate the body's immune response. ATR-002 is under clinical development and has successfully completed a Phase I trial to demonstrate safety and tolerability in healthy subjects. The Company has started a Phase II study to evaluate efficacy in hospitalized COVID-19 patients. A Phase II study in influenza is due to start later in 2021. The Company owns 11 patent families with broad international coverage related to the use of MEK inhibitors and other kinase inhibitors for antiviral therapies. The patent life runs through 2041. Atriva Therapeutics is based in Tübingen and Frankfurt, Germany.

Atriva is a founding member of the BEAT-COV initiative.

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