Covid-19 roundup: Citing a lack of need, Gilead cuts remdesivir study; Novavax vaccine production slowed due to supply shortages
Gilead is halting its remdesivir study in high-risk, non-hospitalized Covid-19 patients after a decision that the study no longer addresses an unmet need, a statement said.
The study’s stoppage is not due to efficacy or safety concerns, the company stated.
“While COVID-19 continues to impact many patients and their loved ones, unmet medical needs have evolved over the course of the pandemic. The primary unmet need for non-hospitalized patients with COVID-19 is for effective and convenient therapies that can be easily administered at home. Gilead remains committed to developing treatment options for non-hospitalized patients with COVID-19 that address this need,” a statement says.
Gilead is still developing inhaled dosage forms of remdesivir in hopes of delivering more convenient treatment.
The news comes as India has announced a ban on exports of the drug, as supply chain instability has rocked the nation. There are over 13 million confirmed cases of Covid-19 in the country, according to the New York Times.
Veklury — the marketed name of the drug — is used in more than half of hospitalized patients with Covid-19, the company said. — Josh Sullivan
Novavax vaccine production slowed due to supply shortages
Supply shortages have led to a delay in Novavax’s timeline for full-speed Covid-19 vaccine production, according to Reuters.
The Maryland company hopes to hit a production target of 150 million doses a month, but supply shortages that include bags used to grow cells are delaying that.
Three weeks ago, the company delayed signing a contract to provide its vaccine to the EU. A temporary US ban on exports of critical raw materials could be, in part, responsible.
Previously, Novavax had said that it could expect full-scale production by May or June. The company has said that UK authorization could come as soon as this month, and clearance from the US could be expected as early as May, Reuters reported. — Josh Sullivan
Rigel says data show fostamatinib meets safety endpoint
Success in a small sample size of data has led scientists to declare positive results in a Phase II clinical trial of fostamatinib for the treatment of patients hospitalized with Covid-19.
Rigel announced that of the 59 patients, three of them saw a reduction in serious adverse effects after being treated with fostamatinib, compared to six patients in the placebo group.
The drug was well-tolerated in hospitalized patients with Covid-19 on oxygen, CMO Wolfgang Dummer said in a statement. After 29 days, there were no deaths in the group given fostamatinib, and there were three deaths in the placebo group. Two intubated patients treated with the drug saw improved symptoms and came off of a ventilator within seven days of being treated, while two patients on ventilators in the placebo group both died.
The drug had previously been approved by the FDA as a second-line therapy for thrombocytopenia in adult patients with chronic immune thrombocytopenia. The drug is designed to block spleen tyrosine kinase and reduce antibody-mediated destruction of platelets. — Josh Sullivan
Kiniksa is back with new data for its repurposed treatment
About four months ago, Kiniksa’s repurposed Covid-19 treatment whiffed on the primary endpoint in the Phase II portion of a Phase II/III study. Now, the company is back with more data that it says paints a brighter picture for non-mechanically ventilated patients.
Kiniksa said on Monday that its mavrilimumab met the primary efficacy endpoint in a cohort of patients with severe Covid-19 pneumonia and hyperinflammation who were not mechanically ventilated. The proportion of patients alive and free of ventilation at Day 29 was 12.3 percentage points higher in the treatment arm compared to the placebo arm, according to Kiniksa. The p-value was 0.1224, which it says met a predefined statistical threshold of <0.2
Through Day 29, Kiniksa says mavrilimumab patients experienced a 65% reduction in the risk of mechanical ventilation or death (p=0.0175). Mortality was 12.5 percentage points lower in mavrilimumab recipients (8%) compared to placebo recipients (20.5%), with a p-value of 0.0718, the company said.
“The results from the Phase 2 portion of the Phase 2/3 trial of mavrilimumab in non-mechanically-ventilated patients with severe COVID-19 signify a potential additive treatment effect of mavrilimumab on top of corticosteroids in reducing mechanical ventilation and death in a diverse population,” CMO John Paolini said in a statement.
Back in December, Kiniksa said that 12 of 21 patients given mavrilimumab in the Phase II, or 57.1%, were alive and off oxygen after two weeks, compared to 9 of 19 patients (47.4%) on placebo. That marked a relative increase of 20.5%, but clocked in at a nominal p-value of 0.536 — more than a full order of magnitude higher than needed to prove significance.
At the time, Kiniksa pointed toward an “encouraging trend” on the secondary endpoint, which also failed to meet statistical significance. After four weeks, 20 of 21 patients were alive and not suffering from respiratory failure, compared to 15 of 19 in the placebo group. Kiniksa’s relative increase in this instance was 20.7%, with a p-value of 0.172.
Kiniksa has completed enrollment in the Phase II portion of the Phase II/III study, and is now enrolling in Phase III. It’s currently in talks with the FDA and other government agencies about potential paths forward, according to a statement. — Nicole DeFeudis
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