Following the readout of a phase II trial evaluating its COVID-19 oral antiviral Pentarlandir (SNB-01), Taiwan’s Syneurx International Corp. said it expects to launch a phase III test of the candidate in the next few months.
An expert panel of Japan’s Ministry of Health, Labour and Welfare (MHLW) pushed back on recommending conditional approval for a second time for Shionogi & Co. Ltd.’s orally administered COVID-19 antiviral 3CL protease inhibitor, S-217622, also known as ensitrelvir.
Respiratory syncytial virus (RSV) continues to be a tough indication. Enanta Pharmaceuticals Inc.’s phase IIb study of otherwise healthy adults treated with EDP-938, an N-protein inhibitor, missed its primary endpoint of reduction in total symptom score compared to placebo. It also missed the study’s secondary antiviral endpoints.
Within just a few hours, Molecular Partners AG reported both a potential snag in securing emergency use authorization (EUA) for its Darpin antiviral, ensovibep, and the loss of a half-billion-dollar partnership with Amgen Inc. for the phase I-stage 4-1BB-targeting compound MP-0310. While neither update is likely to dampen prospects for the company’s overall Darpin pipeline, the near-term investor disappointment was enough to send shares (NASDAQ:MOLN) closing 37% lower April 27, after dropping to their lowest point since the Zurich, Switzerland-based firm priced its $63.8 million IPO on Nasdaq in June 2021.
The Gates Foundation is joining with other philanthropic funders in launching an initiative to develop small-molecule antiviral drugs to lay in as part of preparations for the next pandemic.
Shionogi and Co. Ltd. is looking to become the first company to get approval for a COVID-19 treatment under Japan’s conditional approval system as it prepares a phase III trial for S-217622 (ensitrelvir), its oral antiviral drug for COVID-19.
Redhill Biopharma Inc. continues pushing ahead with efforts to add to the limited arsenal of therapies for treating hospitalized severe COVID-19 infections, with the latest data, based on prespecified analyses from a phase II/III study showing its SK2 inhibitor, opaganib, significantly reduced mortality when given on top of standard-of-care (SOC) Veklury (remdesivir, Gilead Sciences Inc.) and corticosteroids. The Tel Aviv, Israel-based company said potential emergency use and marketing applications are planned in the first half of this year.
Altesa Biosciences Inc. CEO Brett Giroir called the firm’s scientific co-founders George Painter and Dennis Liotta “the most important developers of drugs against viruses on the planet, and probably in history.” Giroir’s remarks came as the College Park, Ga.-based firm launched to develop and commercialize new antiviral drugs against common respiratory bugs such rhinovirus and parainfluenza, as well as vector-borne threats such as Dengue fever, yellow fever, Zika and Powassan.
PARIS – Spartha Medical SAS reported an award of $2.7 million in grants with further, undisclosed equity financing from the European Innovation Council (EIC) Fund, a body run by the European Commission established to make direct equity investment in European Union companies. This fund will be used to initiate clinical evaluation of its multifunctional coating technique.
Pfizer Inc.’s oral antiviral Paxlovid (nirmatrelvir) COVID-19 antiviral looks set for approval in the European Union after it was given the green light by its top regulatory committee. The EMA’s Committee for Medicinal Products for Human Use recommended conditional marketing authorization for treatment of COVID-19 in adults who don’t require supplemental oxygen but are at increased risk for progressing to severe disease.
