Japanese pharma Shionogi’s Covid-19 antiviral against Omicron passed its Phase III trial in Asia, meeting its primary endpoint.
The drug, a protease inhibitor known as ensitrelvir, was administered daily for five days and led to a significant reduction in symptoms such as stuffy or runny nose, sore throat, cough, feeling hot or feverish, and low energy or tiredness within 72 hours of its onset, the company announced Wednesday. A total of 1,821 mostly vaccinated patients from Japan, South Korea and Vietnam were enrolled in the study.
The median time for patients to experience relief in five Covid-19 symptoms was significantly reduced in the cohort that was treated with the low dose of ensitrelvir (the dose level submitted for approval in Japan) compared to placebo: 167.9 hours versus 192.2. No significant adverse effects were noted, the company said.
Meanwhile, the study also hit its secondary endpoint — reduction in viral RNA on day 4 — following the third dose.
The company has submitted the topline results of the Phase III trial to Japanese drug regulators for review. Previously, the regulatory authorities in Japan denied emergency approval for use of the pill, and asked for more data on its effectiveness, Reuters reported.
If approved, Shionogi’s drug could face stiff competition with Covid-19 pills from Pfizer and Merck’s Covid-19 antivirals that have already been approved in Japan and in other countries.
Ocugen enters a deal to commercialize a ‘universal’ intranasal covid vaccine
Pennsylvania-based Ocugen wants to commercialize an intranasally delivered Covid-19 vaccine in the US, Europe, and Japan.
The company has entered a licensing deal with Washington University in St. Louis, which developed the vaccine along with Indian pharmaceutical Bharat Biotech. Ocugen claims that the intranasal shot could be effective against all variants of Covid-19. This vaccine is already authorized for emergency use in India, the company said.
“As the effort to end the pandemic focuses on effective booster options, Ocugen is excited about the potential for this vaccine to be a universal booster, regardless of previous COVID-19 vaccination history,” the company added in a press release.
The vaccine contains spike protein of the SARS-CoV-2 virus, packaged in an adenovirus vector.
According to the company, delivering the vaccine through the nasal route creates strong immunity against the virus in the nose, mouth, upper airways and lungs, where the virus tends to infect the most.
“Because the vaccine can be delivered directly into the nose, it is specifically designed to block infection at the portal of virus entry, and we believe it may help prevent transmission as well as provide protection against new COVID-19 variants,” said Michael Diamond, inventor of the nasal vaccine technology.
Revive’s Covid pill finds a stop sign at the FDA’s doorsteps
Revive Therapeutics has hit a hilly road with its oral Covid-19 drug.
The FDA has rejected the primary endpoint for the Phase III study of the company’s antiviral drug bucillamine. Revive is currently studying the drug’s anti-inflammatory and antiviral properties in patients with mild to moderate Covid-19.
Regulators, however, have asked the company to submit a meeting request to discuss the “appropriate endpoints and justification of the relevance of the revised primary endpoint,” the company said in a press release.
Meanwhile, the company has decided to continue with and review post-dose selection data in around 500 patients.
“Regardless of the outcome, the Company would proceed to seek a meeting with the FDA to agree on a proposed plan for potential regulatory approval,” Revive said in a press statement.
