FDA withdraws two-year clinical ban on CytoDyn’s HIV trial 

USA—The US Food and Drug Administration [FDA] has withdrawn a clinical ban it had previously meted on Cytodyn’s leronlimab, enabling the business to assess the medication as an HIV treatment.  

Leronlimab is an experimental humanized immunoglobulin G4 monoclonal antibody targeting C-C chemokine receptor type 5 (CCR5).  

CytoDyn is also exploring leronlimab as a treatment for Covid-19, glioblastoma multiforme (GBM), and non-alcoholic steatohepatitis (NASH). 

The stock of the US-based company surged by 62.5% at the close of the market on February 29 compared to the previous day’s closing, following the FDA decision. 

Previously, the development of leronlimab encountered obstacles when the FDA fully suspended initially placed a partial clinical hold on the drug’s HIV program in March 2022. 

Despite the lack of updates from the FDA regarding the reasons for the hold, a November 2023 letter to shareholders revealed that CytoDyn had to implement ‘significant reductions’ to its workforce, cash burn rate, and operating expenses. 

Last month, CytoDyn submitted a revised HIV clinical trial protocol to the FDA in hopes of facilitating the lift of the clinical hold.  

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Dr. Jacob Lalezari, CytoDyn’s present CEO, emphasized that the protocol would elucidate how leronlimab could function as an immune modulator in combating the HIV virus. 

 “This protocol will help clarify the mechanisms by which leronlimab can be used as an immune modulator in HIV and a variety of other therapeutic areas.” 

Reportedly, former CytoDyn CEO Nader Pourhassan and Kazem Kazempou, CEO of Amarex, the contract research organization (CRO) employed by CytoDyn from 2013 to 2021, allegedly deceived investors about the timeline and status of FDA submissions to artificially boost CytoDyn’s stock price and lure new investors.  

This occurred after they were charged with securities fraud by the US Department of Justice in December 2022. 

CytoDyn also filed a lawsuit against Amarex, seeking damages, alleging that the CRO “billed the company for services it did not perform,” resulting in “avoidable delays” in obtaining regulatory approval for leronlimab. 

In October 2022, CytoDyn announced that the Phase IIb/III clinical trial of leronlimab as a combination therapy in patients with multi-drug resistant HIV (HIV-MDR) had achieved its primary endpoint. 

 However, the company noted that the data from the study could not be utilized to support the Biologics License Application (BLA) due to “systemic issues related to the quality of the data collection and monitoring of the pivotal clinical trials by the CRO.”  

Consequently, CytoDyn withdrew the BLA for leronlimab as a treatment for HIV-MDR.