CytoDyn Inc. (OTCMKTS: CYDY) has announced the initial result following the unblinding of the data from the ongoing long COVID clinical trial.
Leronlimba alleviated COVID-19 symptoms.
The COVID-19 long-haulers study sought to assess the efficacy and safety of leronlimab delivered subcutaneously weekly to subjects showing prolonged COVID-19 symptoms. The study’s primary endpoint was a change from baseline in COVID-19 related symptom severity through the 56th day. Progression of COVID-19-related symptoms from baseline through day 56 was the study’s secondary endpoint.
The company’s head of clinical development and COO Chris Recknor said they are delighted with the preliminary results from the long-haulers study, which demonstrated enhanced improvement in the patient group that received leronlimab relative to placebo 18 out of 24 coronavirus symptoms. Although Recknor said that the company said that they didn’t design the study to show significant differences because of the small sample size, they nonetheless noticed meaningful clinical improvements in leronlimab.
CytoDyn submits does justification report to the FDA.
The company submitted a dose justification report to the FDA that an IND submission will follow. This is a vital step in the BLA resubmission process for HIV patients showing resistance to standard of care. Notably, the dose justification report is a vital BLA component that entails receptor occupancy analysis and other factors to establish the ideal leronlimab marketed dose. Then, following feedback from the FDA, the company will start BLA modules submission.
Recknor said, “Our team has done a great job and remains focused on the goal of a BLA for HIV. We have a great molecule with many opportunities being evaluated in parallel to the BLA, including COVID, NASH and Oncology. We are on track for the top line report for the COVID-19 long-haulers symptoms/biomarker trial and will soon start two COVID-19 trials in Brazil.”