logo-loader
viewCytoDyn Inc.

CytoDyn claims promising safety data from Phase 2 coronavirus trial of its drug leronlimab

Of the 84 mild-to-moderate coronavirus patients in the study, 19 of the 56 treated with leronlimab reported an adverse event, compared to 14 of 28 who received a placebo

Coronavirus graphic
CytoDyn expects to release the efficacy data from the study once the statistical analysis of primary and secondary endpoints is completed

CytoDyn Inc (OTCQB:CYDY) revealed patient safety data Tuesday from a Phase 2 coronavirus (COVID-19) trial of its drug leronlimab, which showed significantly lower adverse events than a placebo. 

Of the 84 mild-to-moderate coronavirus patients in the study, 19 of the 56 treated with leronlimab reported an adverse event, compared to 14 of 28 who received a placebo. Five patients who received leronlimab reported a total of 8 serious adverse events (SAE), while 6 patients who received a placebo reported 11 SAEs. 

None of the SAEs were related to leronlimab, the company said. One patient died 33 days after enrollment in an event unrelated to the drug.

READ: CytoDyn files to uplist to tech-heavy Nasdaq stock exchange

“When considering treatment options in the Covid-19 population, it is paramount in treating this complex disease to provide patients with therapeutic options that minimize SAEs,” CytoDyn's chief medical officer Scott Kelly said in a statement. “We believe the significant reduction in SAEs in the leronlimab group ultimately translates into improved patient clinical outcomes.”

CytoDyn expects to release the efficacy data from the study once the statistical analysis of primary and secondary endpoints is completed.

“We are very pleased to see clear advantages for the patients in this population in leronlimab versus placebo in regards to SAEs and look forward to announcing all of the efficacy endpoints very soon,” CytoDyn CEO Nader Pourhassan said.

“We are equally optimistic and look forward to the Data Safety Monitoring Committee’s upcoming review of the progress of our Phase 3 trial for Covid-19 patients with severe and critical indications and remain hopeful the therapeutic benefits for this patient cohort will be consistent with the results we saw from the administration of leronlimab to over 60 patients under eIND authorizations previously granted by the US Food and Drug Administration.”

Leronlimab has a history of being well-tolerated, according to CytoDyn senior science advisor, Jacob Lalezari.

“We are delighted to see a clinically meaningful reduction in SAEs in the mild-moderate COVID-19 population,” Lalezari said. “Leronlimab has been extremely well tolerated in prior clinical trials in over 750 HIV+ patients. These new safety data are therefore consistent with our prior experience and very encouraging in the Covid-19 population. The once-a-week subcutaneous administration of leronlimab is also convenient for patients and caregivers alike.”

Contact Andrew Kessel at [email protected]

Follow him on Twitter @andrew_kessel

Quick facts: CytoDyn Inc.

Price: 4.81 USD

OTCQB:CYDY
Market: OTCQB
Market Cap: $2.5 billion
Follow

Add related topics to MyProactive

Create your account: sign up and get ahead on news and events

NO INVESTMENT ADVICE

The Company is a publisher. You understand and agree that no content published on the Site constitutes a recommendation that any particular security, portfolio of securities, transaction, or investment strategy is...

In exchange for publishing services rendered by the Company on behalf of CytoDyn Inc. named herein, including the promotion by the Company of CytoDyn Inc. in any Content on the Site, the Company receives from said...

FOR OUR FULL DISCLAIMER CLICK HERE

Watch

CytoDyn’s Leronlimab receives positive DSMC recommendation in ongoing Phase...

CytoDyn (OTCQB: CYDY) CEO Nader Pourhassan and Chief Scientific Advisor Dr Jay Lalezari joined Steve Darling from Proactive with news the company has had results from an independent Data Safety Monitoring Committee who completed its first safety review of the ongoing Phase 3 clinical trial of...

14 hours, 48 minutes ago

2 min read