CytoDyn Inc has told investors that data from its trial treating non-alcoholic steatohepatitis (NASH) with its flagship drug leronlimab are “encouraging” and an “exciting step forward” in demonstrating the potential of the drug for inhibiting the liver fibrosis associated with NASH.
The late-stage biotechnology company said the open-label NASH results continue to show reductions in fat and fibrosis suggestive of a potential therapy not only for non-alcoholic fatty liver deposit (NAFLD) but also in NASH.
Leronlimab (350 mg) for weekly use was used for 14 weeks in the open-label arm of the NASH trial, producing fibrosis reduction as high as 93 milliseconds (msec) in the first 15 patients with an average reduction of 24 msec, it said.
The company said fat reductions by proton density fat fraction (PDFF) up to 45% along with reductions in fibrosis up to 8% by CT1 were noted from baseline after just 14 weeks of treatment. The reductions in fibrosis were seen in both severe and mild-moderate NASH cases.
“Though numerous drugs have been evaluated in clinical trials, there have been no approvals by the US Food and Drug Administration for treating biopsy-proven NASH,” president and CEO Nader Pourhassan said in a statement.
“We are encouraged by the continued results and look forward to presenting the full trial results after database lock.
“CytoDyn will now file for Fast Track Designation for both the indications of NASH and NAFLD. Once the full results are reported, which we anticipate to be available in mid-December, we may proceed to file a Phase 3 protocol with the FDA and request accelerated approval.”
CytoDyn, a late-stage biotechnology company, is developing innovative treatments for multiple therapeutic indications using leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor.
CCR5 plays a critical role in the ability of HIV to enter and infect healthy T-cells and appears to be implicated in tumor metastasis and immune-mediated illnesses, such as NASH.
The company completed a Phase 3 pivotal trial using leronlimab combined with standard antiretroviral therapies in HIV-infected patients who were heavily treatment-experienced individuals with limited treatment options.
In July 2021, CytoDyn announced that it had submitted a dose justification report to the FDA, an integral step in the resubmission process for its BLA, which it expects to complete by the end of the first quarter of calendar 2022.
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