Atriva Therapeutics Doses First Patient in Phase II RESPIRE trial in COVID-19

- Charité - Universitätsmedizin Berlin, Germany, enrolls first patient in Phase II study to assess oral treatment ATR-002

- RESPIRE is a placebo-controlled, international, multi-center trial in hospitalized patients with moderate to severe COVID-19

Tübingen (Germany), April 13, 2021 - Atriva Therapeutics GmbH, a biopharmaceutical company that is pioneering the development of host-targeting antiviral therapies, announced today that the first patient was enrolled in its Phase II RESPIRE trial in COVID-19. Prof. Martin Witzenrath, M.D., Vice Director Department of Infectious Diseases and Respiratory Medicine, supervised the first administration of study medication (MEK inhibitor ATR-002 or placebo) at the Charité - Universitätsmedizin Berlin, Germany.

"We are excited to assess the efficacy of ATR-002 in treating COVID-19 and are looking forward to the results of the clinical trial. We can now test our lead candidate against SARS-CoV-2 because our pharmacological target is a common cellular mechanism that RNA viruses use. ATR-002 leaves the virus itself untouched but blocks a cellular factor that the virus needs for its replication and has the potential to reduce the viral load in the infected host," said Dr. Rainer Lichtenberger, CEO of Atriva Therapeutics. "Host-directed approaches maintain efficacy also against mutated viruses - a problem that we are commonly seeing in the influenza virus and, unfortunately, in SARS-CoV-2 as well. If we were to see the positive outcomes of the trial we hope for, ATR-002 could provide efficient help against COVID-19 regardless of the given genetic subtype of the underlying viral strain."

"While we have been lucky that SARS-CoV-2 vaccines were developed at unprecedented speed, we still are in desperate need for effective therapies against COVID-19. The pandemic situation remains very critical and is far from being under control," added Global Coordinating Investigator of the RESPIRE trial Prof. Gernot Rohde, M.D., Head of Pneumology and Professor for Respiratory Medicine and Allergology at the Goethe University Hospital, Frankfurt am Main, Germany. "Being able to contribute to the development of a COVID-19 therapy, I am very much looking forward to the effects that we may see with ATR-002. I am convinced that a medication that can prevent hospitalized patients with a moderate to severe stage of COVID-19 from deteriorating and requiring ICU admission and ventilator support would mean a huge progress and could also play a role in impeding the severe long-term effects that are being described as "Long COVID" Syndrome (PASC)."

RESPIRE is a randomized, double-blind, placebo-controlled, international, multi-center Phase II clinical trial in 220 adult patients with moderate to severe COVID-19, requiring hospitalization, but not requiring ICU admission or ventilator support at the time of screening or randomization. On top of standard of care, half of the patients will receive ATR-002 900 mg, administered as tablets once daily on day 1, followed by ATR-002 600 mg once daily on days 2 to 6. Patients in the control group will receive placebo in a matching scheme, on top of standard of care.

Primary objective of the study is to demonstrate the efficacy of ATR-002 versus placebo in addition to standard of care; secondary endpoints include the measurement of changes in clinical signs and symptoms as well as other relevant clinical parameters. Outcomes will be assessed based on the clinical severity status on day 15, using a 7-point ordinal scale as suggested by the WHO COVID-19 Therapeutic Trial Synopsis. All patients will be followed-up for 90 days. The study will also evaluate the pharmacokinetics of ATR-002.

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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