Atriva Therapeutics to develop ATR-002 for treatment of patients with COVID-19

• ATR-002 mode of action inhibits SARS-CoV-2 viral propagation and prevents the cytokine storm as demonstrated in preclinical studies
• Atriva’s lead product candidate is the only host-targeted antiviral specifically developed to treat respiratory infections with RNA viruses, such as influenza virus and the novel SARS-CoV-2
• With its dual antiviral and immunomodulatory effect, the small molecule may prevent progression to critical-stage COVID-19 in hospitalized patients and holds strong potential in the current pandemic

TÜBINGEN, Germany, May 28, 2020 (GLOBE NEWSWIRE) — Atriva Therapeutics GmbH, a biopharmaceutical company pioneering the development of host-targeting antiviral therapies, today announced a clinical strategy to treat patients with moderate to severe COVID-19 who require hospitalization. ATR-002, an oral small molecule, has been proven in preclinical trials to block viral propagation of SARS-CoV-2 and to have an immunomodulatory effect leading to a decreased cytokine and chemokine release. This dual benefit makes the MEK-inhibitor ATR-002 particularly relevant for the treatment of COVID-19.

ATR-002 has been developed specifically to treat respiratory viral infections by inhibiting MEK, a host cell factor required for the replication of various RNA viruses, including influenza virus and SARS-CoV-2. Preclinical studies, using virus strains from the recent German COVID-19 outbreaks, performed at the Universities of Tübingen and Münster have demonstrated that MEK inhibition by ATR-002 prevents SARS-CoV-2 replication. In addition to its antiviral efficacy, ATR-002 shows a second beneficial effect: The MEK-inhibitor was able to significantly decrease pro-inflammatory cytokine and chemokine expression in cell lines, primary human cells, and an animal model of acute lung injury (ALI). Thus, ATR-002 could prevent a cytokine storm and the associated disease progression to a life-threatening condition in patients with COVID-19. Its mechanism of action with a dual benefit, antiviral activity and immunomodulation, uniquely positions ATR-002 as a promising therapeutic candidate. The Company has filed respective patents with the European Patent Office. Further, ATR-002 has successfully completed a Phase I clinical trial in 2019 where it demonstrated excellent safety and tolerability in healthy volunteers.¹

“With ATR-002, we developed a small molecule to specifically address the major need for an efficient antiviral therapy for severe respiratory infections caused by RNA viruses,” said Dr. Rainer Lichtenberger, co-founder and CEO of Atriva. “ATR-002 could be a game changer in the current pandemic as we see high potential for a patient-friendly, oral medication that fundamentally impacts COVID-19 outcomes.² To develop ATR-002 for COVID-19 is therefore a logical step in these times and possibly vital for national health systems, patients and families. Our influenza development programs will benefit strongly from synergies in clinical development and scale-up in the production of ATR-002.”

Atriva is now starting a multinational, double-blind, randomized Phase II clinical study with the oral small molecule ATR-002 to treat COVID-19 in July 2020. The trial will aim to demonstrate its efficacy against moderate COVID-19, compared to placebo, in hospitalized patients.

“The preclinical findings are very encouraging. Treating moderately to severely-sick patients aims to reduce the number of critically ill people, otherwise referred to ICUs and requiring more invasive treatment options,” said Dr. Martin Bauer, Atriva Chief Medical Officer. “From the earliest stages of development, it has been our ambition to provide a powerful antiviral to treat influenza and other severe respiratory viral infections. At this point, finding an effective therapy to treat moderate to severe cases of COVID-19 is essential for national healthcare systems as we anticipate pandemic infections to remain on the public health agenda.” With ATR-002, Atriva not only has developed an effective antiviral compound, but at the same time a defense against the overwhelming cytokine release.³

The small molecule drug can be manufactured via chemical synthesis and allows for rapid scale-up of production to meet high levels of demand. Evonik Industries AG, a German-based world leader in specialty chemicals, serves as the development and manufacturing partner to produce the ATR-002 medication for the Phase II clinical study, under its long-term collaboration with Atriva. In parallel, Atriva is preparing for the ramp-up of ATR-002 production to provide enough doses for extended clinical trials and market access following trial completion. –BioSpace