Another COVID-19 therapy bites the dust. This time it’s Adamis Pharmaceuticals’ failed phase 2/3 trial for antiviral Tempol, triggering a drop in its share price.
The therapy, which forms the entirety of Adamis’ clinical pipeline, missed its primary endpoint of showing greater level of clinical resolution of COVID-19 symptoms at day 14 compared to those receiving standard of care of nonhospitalized COVID patients. After an interim analysis, the independent Data Safety Monitoring Board recommended the study be halted early due to lack of efficacy. The trial had a target enrollment of 248 patients, and its registry page, which was last updated mid-August, notes that the study was still recruiting.
The company followed the board’s advice and said it will now evaluate the unblinded data to determine next steps for the drug. Adamis is trying to stay positive and will explore its theory that a combination of vaccinations and less virulent variants of COVID-19, namely omicron, may have obscured the effects of Tempol in the trial. To back up this view, the company pointed to a lower-than-expected hospitalization rate of below 1% compared to other COVID-19 treatment trials.
“We will continue to analyze the data to determine if we believe Tempol can be utilized in other COVID patient populations including those with more severe illness or immunocompromised,” Adamis Chief Medical Officer Ron Moss, M.D., said in a release.
Investors appeared unconvinced by the company’s explanation. Adamis’ shares dropped 44% to 20 cents apiece Wednesday morning, compared to a prior close of 35 cents.
CEO David Marguglio said in the release that the results were frustrating and emphasized that the company remains “bullish” about the prospects for its approved drugs Zimhi for opioid overdose and Symjepi for anaphylaxis. “Our team is focused on increasing sales and improving manufacturing efficiencies for our commercial products.”
This focus on its approved portfolio makes sense when you consider Tempol is the only drug left in the company’s pipeline. While it may be out of the running for COVID-19, Adamis is preparing a gel version to enter phase 3 trials for radiation dermatitis, with an oral capsule form ready for phase 2/3 studies in respiratory disease.
It’s been a tough year for biotechs’ COVID therapy ambitions, with Akebia narrowly missing on its drug vadadustat last month and Synairgen’s inhaled interferon beta candidate SNG001 falling at the final hurdle back in February.