- Eli Lilly on Wednesday announced the interim results of a Phase 2 study that found a drug based on an antibody of a recovered Covid-19 patient lowered hospitalization rates of mildly and moderately ill Covid-19 patients when compared with a placebo. According to Daniel Skovronsky, chief science officer at Eli Lilly, the results from the Phase 2 trial—which have not been published or independently peer-reviewed—are "proof of concept that show an antibody against the virus can neutralize the virus in patients, which can have a beneficial effect on symptoms and hospitalizations." Eli Lilly said it will speak with regulators about next steps, but said it's too early to speculate whether the study results could lead to emergency use authorization (EUA) of the drug (AP/Modern Healthcare, 9/16; Loftus, Wall Street Journal, 9/16; Kolata, New York Times, 9/16).
- Eli Lilly on Monday said Olumiant, the company's rheumatoid arthritis drug, when combined with remdesivir shortened Covid-19 recovery time by about a day compared with patients treated with remdesivir alone in a study of more than 1,000 patients. The drugmaker said it will discuss a potential EUA from FDA for Olumiant to treat hospitalized Covid-19 patients (Anderson, Becker's Hospital Review, 9/15).
- Albert Bourla, CEO and chair of Pfizer, said there's a "good chance" Pizer will know whether its experimental coronavirus vaccine is effective by the end of October—although he did not know whether Americans would be able to receive the drug before 2021 due to the need to go through approval processes. Nonetheless, according to Bourla, Pfizer has already manufactured hundreds of thousands of doses, preparing as if it will receive approval and be permitted to distribute the drug before the end of the year (Anderson, Becker's Hospital Review, 9/14).
- Merck has started a Phase 1/2 trial of one of its experimental coronavirus vaccine candidates. The trial, based in Belgium, will enroll 260 participants and aims to wrap up in April 2022. According to the Wall Street Journal, the trial aims to assess the vaccine candidate in healthy volunteers to ensure its safety and efficacy (Hopkins, Wall Street Journal, 9/11).
- NIH has opened an investigation into the case of a participant in AstraZeneca's coronavirus vaccine trial who developed spinal cord damage. Although the trial, which was stopped last week, has been permitted by British regulators to resume in the United Kingdom, FDA has yet to allow the trial to resume in the United States. "The highest levels of NIH are very concerned," Avindra Nath, intramural clinical director and a viral research leader at NIH's Neurological Disorders and Stroke division, said. "Everyone's hopes are on a vaccine, and if you have a major complication the whole thing could get derailed." Although details of the case remain unclear, AstraZeneca has said the individual recovered from a severe inflammation of the spinal cord and has been discharged from the hospital (Allen/Szabo, Los Angeles Times, 9/15).
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