CytoDyn’s leronlimab has suffered a blow to its Likelihood of Approval (LoA) score, which dropped by 9 points, as of 18 May. This was after the FDA released a statement on the previous day saying data from two clinical trials did not support leronlimab’s development as a therapy for Covid-19.
Leronlimab, a CCR5 antagonist, is being studied in several Covid-19 studies, including a Phase II CD10 study and a Phase II CD12 trial. The company had issued a release on 30 March which indicated leronlimab’s use on top of SOC in the CD12 study decreased mortality by 82% at 14 days, in 62 critically ill patients, or those receiving mechanical ventilation or extracorporeal mechanical oxygenation (ECMO). However, the FDA noted that this was only a subgroup analysis from a 394-patient dataset. While such data may guide design of future studies, these subgroup analyses did not meet statistical significance, the FDA stated.
Similarly, in the CD10 trial that recruited those with mild-to-moderate Covid-19 disease, leronlimab did not show clinically meaningful differences in the trial’s primary endpoint of an improvement in total symptom score, that looked at symptoms like fever, cough, shortness of breath, and muscle aches measured at day 14, as per the FDA. While the score was -3.5 on the leronlimab arm, it was -3.4 in the placebo group. Additionally, the trial did not meet any of the secondary endpoints like mortality and time to symptom resolution.
In general, the regulatory agency does not share confidential information on unapproved therapies, which made this comment unique. But the FDA stated that it chose to do so given the public interest in leronlimab and in research to treat or prevent Covid-19. The LoA score which is calculated by GlobalData’s analysis, that uses a combination of machine learning and a proprietary algorithm, was originally 34% which has since then been lowered to 25%. CytoDyn’s market cap is $1.33bn.
Manasi Vaidya is a Associate Editor for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.