After news of leaked clinical trial results sent shares of a company developing a drug for Covid-19 soaring, a member of Congress is asking federal regulators to look into how the results were leaked in the first place.
CNN reported Friday that Rep. Lloyd Doggett, D-Texas, and chair of the House Ways and Means Health Subcommittee, had called for the Securities and Exchange Commission to investigate the leak of a video in which the physician leading Foster City, California-based Gilead Sciences’ clinical development program for the drug remdesivir discusses early and confidential data from the trial.
The leaked video, originally reported by STAT, shows Dr. Kathleen Mullane, a physician at the University of Chicago and lead investigator of the remdesivir program, discussing early data from 125 patients in the study enrolled at her center. In particular, the results – while extremely limited due to their anecdotal nature – appear to indicate the drug has efficacy, particularly in patients with severe disease.
Shares of Gilead went up by 12% following the news last week. The company is running two Phase III studies: one in 1,600 patients with moderate disease and another in severe disease, whose enrollment target was recently increased from 400 to 2,400 and then again to 6,000. Notably, the severe-disease study lacks a control arm, further complicating any attempt to interpret the leaked results, which mostly came from that study.
Doggett called the leak “so significant” when people are “so desperate to find a cure” for Covid-19, adding that “providing information that’s designed to impact the stock market is not something that is permitted under federal securities law,” CNN reported. However, it is unclear who was responsible for the leak or why the leak took place, and Gilead has denied being behind it.
On April 10, Gilead released data on 53 patients with severe disease treated with the drug under compassionate use protocols. However, it is also a challenge to interpret those data given the small numbers and lack of a control arm, and the company itself emphasized their limitations as well.
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