Covid-19 roundup: Atea Pharmaceuticals launches antiviral into PhIII trial; Celltrion's antibody shows promise against variant

29 Apr 2021
endpts.com
VaccineCollaborateAntibodyEmergency Use Authorization
About a year after jumping into the Covid-19 fight with its lead antiviral, Atea Pharmaceuticals has launched a Phase III trial in mild to moderate patients who are not hospitalized. The drug (and company) come from Jean-Pierre Sommadossi, the founder of Idenix and a co-founder of Pharmasset. The company decided to divert all their attention to Covid-19 last February, then pulled in $215 million to launch a cross-country Phase II trial in May. “Hopefully we will not have a second wave,” Sommadossi told Endpoints News at the time. “But if we have a second wave, we need to be ready this time.” In October, Roche put down $350 million upfront plus undisclosed milestones and royalties for ex-US rights to the candidate, dubbed AT-527, as an oral antiviral treatment for Covid-19. The therapy works by blocking the viral RNA polymerase enzyme needed for viral replication, according to Roche. The Phase III MORNINGSKY trial will enroll 1,400 non-hospitalized patients, including adolescents, who are within five days of symptom onset. The study’s primary endpoint will evaluate the time to improvement of symptoms compared to a placebo. Participants will come from a variety of clinical trial sites worldwide, including in Japan, according to Atea. In addition to MORNINGSKY, Roche and Atea are testing the candidate in a global Phase II for hospitalized patients with moderate Covid-19, and a Phase II virology study in outpatients with mild to moderate sickness. “As a direct-acting antiviral, AT-527 aims to prevent disease progression by inhibiting viral replication and thereby reducing the severity of disease, preventing or shortening hospitalization, and also potentially preventing transmission of the virus to others,” Sommadossi said in a statement. “This makes it well-suited for potential use in both pre- and post-exposure prophylactic settings and complementary to vaccines.” — Nicole DeFeudis Celltrion’s mAb shows success against South African variant Pre-clinical trial results from Celltrion Group’s anti-Covid-19 monoclonal antibody regdanvimab showed neutralization of the South African variant, the company announced Thursday. Regdanvimab proved effective in an in vivo model by binding against the receptor binding domain in three mutations (K417N, E484K and N501Y) of the variant, Celltrion said in a release. However, it also showed reduced susceptibility against the South African variant in a live virus and pseudo-virus in vitro study though there was no significant difference between the variants and the wild type when observing viral respiratory infection. In a statement, head of medical and marketing Ho-Ung Kim said, “Faced with the rapid spread of COVID-19 variants, global access to effective antibody treatment is fundamentally important to reduce the disease progression rate to severe COVID-19 and help outpatients avoid hospitalization and alleviate the burden on the health care system. We have commenced the development of a neutralizing antibody cocktail with CT-P59 against new emerging strains in the UK and South Africa and we will continue to further investigate the neutralizing antibodies and other responses to protect against current SARS-CoV-2 strains and emerging variants.” In March, the European Medicines Agency announced that the mAb could be used as treatment for adults who don’t require supplemental oxygen and are at high risk of progressing to severe Covid-19. The EMA said that most side effects reported were mild or moderate, but results weren’t robust enough to reach a conclusion on the medicine’s benefits. The company began mass producing the mAb in September 2020 in hopes of getting emergency use authorization. — Josh Sullivan Pfizer/BioNTech could have vaccine trial results for younger children by September — report BioNTech CEO Ugur Sahin says the company could have a look at how its Pfizer-partnered Covid-19 vaccineCovid-19 vaccine works in babies as young as six months old by September, according to Reuters. “In July, the first results could be available for the five to 12 year olds, in September for the younger children,” he told the German magazine Der Spiegel, per Reuters. Earlier this month, Pfizer and BioNTech asked the FDA to expand its EUA to include adolescents 12 to 15 years old. A couple weeks ago, Moderna said its Phase II/III TeenCOVE study is fully enrolled with about 3,000 participants between the ages of 12 and 17 in the US. Meanwhile, its Phase II/III KidCOVE study was still recruiting children between 6 months and 11 years old. — Nicole DeFeudis
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