CytoDyn’s efforts to get leronlimab past the regulatory finish line in any indication has been a saga—including an incident in which the biotech sent the wrong data sets to the FDA. But now, the regulator seems to have pointed the biotech in the right direction for a filing for approval in HIV.
In a brief update Friday morning, CytoDyn disclosed that the FDA has sent over some comments on the company’s recently resubmitted dose justification report. That report is “an important component” to the company’s efforts to resubmit a biologics license application (BLA) for leronlimab in HIV.
Let’s back up here and review why the resubmission is happening in the first place: Back in July 2020, the FDA rejected CytoDyn’s application because of missing information. This came a few months after the company revealed that the wrong data sets had been submitted for review.
The biotech said they would not need to carry out any new clinical trials to resubmit but would instead further analyze data from trials that had already been completed. The mix-up caused CytoDyn’s shares to slide.
So here we are, more than a year later, and CytoDyn says they have what they need to get the resubmission process finished up. The brief statement did not provide details on what the FDA said, but the company believes all the issues are "addressable."
It's not clear when the entire BLA package will be resubmitted, but CytoDyn expects to have the chemistry, manufacturing and controls and non-clinical sections resubmitted as early as September.
“We are encouraged by the guidance and comments received from the FDA,” said CytoDyn President and CEO Nader Pourhassan, Ph.D. “Our management team and regulatory advisory team are confident that we will be able to successfully address these comments, allowing the further advancement of our BLA resubmission. In our view, this is a major step forward in our BLA process.”
The CEO went on to say that CytoDyn is in an “exciting period” as they work towards resubmitting the BLA and initiating two COVID-19 clinical trials for leronlimab in Brazil. The company also has “possibly a strong clinical trial” in the works for COVID long haulers in the U.S.
Pourhassan’s statement comes three months after he begged investors, in a bizarre conference call. to stop trashing the FDA. The agency had made a rare public rebuke of CytoDyn’s COVID program, saying that the data for leronlimab did not support a clinical benefit. The agency suggested that CytoDyn had cherry-picked data from two failed studies of leronlimab to claim the drug is effective.
Subsequently, investors lashed out at the U.S. regulator and asked CytoDyn to correct the record. Pourhassan said there was nothing to correct and noted several times that he was "grateful" for the agency.
The company had pumped up the drug in public statements anyway, claiming success in a pair of trials that had clearly failed. The action has since caught the eye of the Department of Justice and the Securities and Exchange Commission, CytoDyn disclosed in a filing earlier this month.
CytoDyn is also trialing leronlimab in, well, pretty much everything, including 22 different solid tumor cancers, autoimmune diseases such as psoriasis and Crohn’s disease, graft-versus-host disease and nonalcoholic fatty liver disease.
Leronlimab has been studied in combination with standard retrovirals in a phase 3 clinical trial of HIV patients who were heavily pretreated and had limited treatment options. CytoDyn said trial results have shown that the therapy "can maintain a suppressed viral load" in a certain population of HIV patients who had switched from their daily pill regimen to receiving leronlimab once a week. Some patients in an extension arm of a phase 2b trial have maintained suppression for almost seven years, the company said.
Shares of the biotech were trading up about 3.5% Friday morning at $1.46 as another chapter was added in the leronlimab saga.