After getting ditched by Roche a month ago, Atea Pharmaceuticals is laying out a new path for a failed COVID-19 med called AT-527, including a plan to conduct combination studies.
Back in November, Roche cut ties on a $350 million deal with the small biotech after the drug failed to live up to expectations in the clinic.
Atea now has a new strategy, and it says the “rapidly evolving SARS-CoV-2, emerging variants and changing treatment landscape” are to blame for the change in direction. The biotech plans to expand the clinical program for AT-527 to include combination studies but did not name which compounds it intends to try.
The biotech is heading back to the lab to study possible combinations that could work.
CEO and founder Jean-Pierre Sommadossi, Ph.D., said the company believes AT-527 could be “an important backbone” when used with other meds.
“Our new strategy enables us to rapidly drive forward a plan to maximize AT-527’s unique profile with a development approach designed to meet the current and future needs of COVID-19, which may include the emergence of new variants and drug resistance to other therapies,” said Sommadossi, who previously co-founded Sovaldi developer Pharmasset.
Atea plans to close out the phase 3 MORNINGSKY trial that was being conducted with Roche as well as the follow-up called MEADOWSPRING. The collaboration will officially terminate Feb. 10, 2022.
Chief Development Officer Janet Hammond, M.D., Ph.D., said continuing with the MORNINGSKY program “is not the most effective path forward” considering the rapidly changing pandemic, the emergence of new variants and the availability of new COVID-19 treatments.
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A phase 2 trial of AT-527 alone featuring hospitalized patients with COVID-19 will continue with an amended protocol expanding enrollment to outpatients who are unvaccinated and high-risk. The study originally included patients who were being cared for in a hospital or other confined setting. After the amendment, 200 patients will be accepted, with a data readout expected sometime in 2022.
The company will provide more details on its strategy and development plan next year.
“Importantly, we have the financial and internal resources to execute this strategy through key clinical and regulatory inflection points,” Sommadossi said.