Clinical Trials Arena

FDA lifts two-year clinical hold on CytoDyn’s HIV trial

The US Food and Drug Administration (FDA) placed a partial clinical hold on HIV programme and a full hold on Covid-19 trials for CytoDyn’s monoclonal antibody, leronlimab.

The FDA has lifted the clinical hold on Cytodyn’s leronlimab, allowing the company to evaluate the therapy as a treatment for human immunodeficiency virus (HIV).

Following the FDA decision, the US-based company’s stock was up by 62.5% at the market close on 29 February, compared to the market close on the previous day.

Leronlimab’s development has been tumultuous. The FDA first placed a partial clinical hold on the drug's HIV programme and a full clinical hold on the Covid-19 programme in the US in March 2022. The company did not provide an update on the reasons behind the hold.

According to a November 2023 letter to shareholders, CytoDyn had to make ‘significant reductions’ to its workforce, cash burn rate, and operating expenses.

Last month, CytoDyn submitted a revised HIV clinical trial protocol to the FDA to aid in the lift of the clinical hold by the FDA. Again, the company provided little details on the reason for the clinical hold. However, CytoDyn’s current CEO Dr Jacob Lalezari stated: “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.”

In December 2022, former CytoDyn CEO Nader Pourhassan and Kazem Kazempour, CEO of Amarex, the contract research organisation (CRO) employed by CytoDyn from 2013 to 2021, faced charges for securities fraud scheme from the US Department of Justice. The two CEOs allegedly deceived investors about the timeline and status of FDA submissions to inflate CytoDyn’s stock price and pull in new investors. CytoDyn also filed a lawsuit against Amarex seeking damages alleging that the CRO “billed the company for services it did not perform” and CytoDyn suffered ‘avoidable delays’ in obtaining regulatory approval for leronlimab.

In October 2022, CytoDyn announced the Phase IIb/III clinical trial of leronlimab as a combination therapy in patients with multi-drug resistant HIV (HIV-MDR) met its primary endpoint. However, the company noted that the data from the study could not be used to support the BLA due to "systemic issues related to the quality of the data collection and monitoring of the pivotal clinical trials by the CRO". As a result, CytoDyn withdrew the BLA for leronlimab as a treatment for HIV-MDR.

Leronlimab is an experimental humanised immunoglobulin G4 monoclonal antibody that targets C-C chemokine receptor type 5 (CCR5). CytoDyn is also evaluating leronlimab as a treatment for Covid-19, glioblastoma multiforme (GBM), and non-alcoholic steatohepatitis (NASH).