CytoDyn finally clears FDA hold on HIV program after 2 years

After two years, CytoDyn’s HIV program is finally free of the FDA clinical hold.

In a short update Thursday, CEO Jacob Lalezari, M.D., heralded the lifting of the hold as a “new chapter” for lead asset leronlimab, which has been tested in multiple indications without success so far. The company is now cleared to advance a trial in HIV.

Leronlimab was placed on clinical hold in March 2022, with a partial pause on the HIV program and full hold in COVID-19. At the time, CytoDyn did not provide many details on the reasons behind the hold.

In a November 2023 letter to shareholders, Board Chair Tanya Durkee Urbach said the year “proved to be a very difficult” one for the company as the FDA had refused to relent. The biotech pledged to release the hold by hosting advisory board meetings with key opinion leaders.

CytoDyn also cut staff, cash burn and operating expenses to continue moving forward, while working on setting up a trial for leronlimab in metabolic dysfunction-associated steatohepatitis (MASH) either alone or in combination with other meds. Durkee Urbach said these tests “could be attractive to a partner and position the company for a greater chance of success within the MASH space.”

“We understand that CytoDyn’s recent challenges may have tested your confidence. We want to assure you that we remain dedicated to developing important therapeutics that can make a difference in patients' lives, and at the same time provide value for our shareholders,” Durkee Urbach wrote at the time.

Earlier this month, CytoDyn finally submitted a revised protocol for the HIV trial, which again had little detail on the nature of the FDA's concern. Lalezari, who officially ascended to the CEO role in January, was confident that the amendment would finally convince the FDA to lift the hold.

The lifting of the hold is indeed another chapter in the long, difficult history of CytoDyn. In December 2022, former CEO Nader Pourhassan, Ph.D., was charged along with Amarex CEO Kazem Kazempour for their alleged roles in schemes to defraud investors. The two executives were accused of exaggerating the progress of CytoDyn’s leronlimab.

The therapy has been through the ringer in the clinic, with unsuccessful testing in COVID-19, and a failed attempt at approval in HIV that was pulled in October 2022.

The company is now back at it, with a new trial that hopes to show that the monoclonal antibody can help HIV patients who have increased inflammation and immune activation.

Shares of CytoDyn, which is listed on the Other OTC markets, gained around 20% on Thursday, rising to 19 cents compared to 16 cents at close yesterday.