The FDA wanted a couple more clinical studies for Qualigen’s investigational COVID-19 antiviral before human testing, but the biotech is calling it quits instead.
Shares of the company plunged nearly 20% to $1.34 as the markets opened Tuesday, underscoring the risk that small companies take on when trying to jump into the race for a better COVID-19 treatment.
Infectious disease medicine QN-165 will be shelved for now, as Qualigen shifts focus to its oncology pipeline, including QN-247 and RAS-F for a variety of cancers, the company said during a second-quarter earnings report Tuesday.
Qualigen had ramped up R&D operations to push QN-165 through the testing in hospitalized COVID-19 patients. The company spent $3.4 million on the therapy during the second quarter out of a total $4.5 million in R&D expenses. This compares to a spend of $600,000 for the same period a year ago.
Looking across the first half, R&D expenses were $8 million, with $5.9 million attributed to QN-165. In comparison, the company spent $800,000 in the first half of 2020 on R&D. Qualigen also previously withdrew a COVID-19 antibody diagnostic test, which added to the R&D charges.
The FDA has now asked the biotech to conduct additional preclinical toxicity and safety pharmacology studies on QN-165 before moving research into COVID-19 patients.
“We believe that, given the time horizon which these suggested studies would require, coupled with the already very crowded COVID-19 vaccine and therapeutic landscape, the best and most prudent strategy for us at this time is to pivot to focusing primarily on our oncology pipeline,” said Chairman and CEO Michael Poirier in a statement.
The company announced as recently as July that it was pursuing an investigational new drug application with the FDA for QN-165, which, if approved, would have authorized human testing.
QN-165 has shown antiviral activity against different viruses, according to Qualigen. The therapy is listed on the company's website as in development for viral based-infectious diseases and different types of cancer.
The U.S. government has been pushing for new antiviral treatments that can improve on existing COVID-19 treatment options. The new delta variant has been straining the effectiveness of existing therapies and in fact has rendered some ineffective.
Even the big wigs have had trouble keeping up in the market. Eli Lilly, which once boasted an FDA authorization for the solo antiviral bamlanivimab, has been sent back to the drawing board after being beaten by the coronavirus variants. The company is now marketing it as part of a combination treatment with another antibody, etesevimab, but the National Institutes of Health is no longer recommending the combo either due to the variants.
AstraZeneca also missed the mark in June in a phase 3 postexposure prevention trial for an anti-SARS-CoV-2 antibody combination.
As for smaller companies, Humanigan is currently seeking authorization for a COVID-19 therapeutic in the U.S. and U.K., ahead of rival I-Mab, which just revealed top-line results for a phase 2/3 study of a similar candidate.