Atriva Therapeutics Doses First Patient in Phase II RESPIRE trial in COVID-19
13.04.2021
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 serve 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 RESPIRE1 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).”
RESPIRE1 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.2 All patients will be followed- up for 90 days. The study will also evaluate the pharmacokinetics of ATR-002.
Atriva is a founding member of the BEAT-COV initiative. www.beat-cov.de
For further information, please visit www.atriva-therapeutics.com and follow us on LinkedIn and Twitter.
Contact
Atriva Therapeutics GmbH
Dr. Rainer Lichtenberger, CEO
phone: +49 6196 56 11 698
mobile: +49 151 7443 3175 lichtenberger@atriva-therapeutics.com
Media and Investor Relations:
MC Services AG
Eva Bauer / Raimund Gabriel phone:
+49 89 210 228 80 atriva-therapeutics@mc-services.eu
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