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CytoDyn requests fast track approval for leronlimab from UK regulators to treat coronavirus patients

The biotechnology company said it has provided the regulator with a top-line report from its recently completed phase 2 clinical trial of leronlimab in patients with mild-to-moderate coronavirus symptoms, noting the “efficacy and safety results” from the study

CytoDyn Inc. - CytoDyn requests fast track approval for leronlimab from UK regulators to treat coronavirus patients
The firm has made the request to the UK's Medicines and Healthcare Products Regulatory Agency

CytoDyn Inc (OTCQB:CYDY) said it has requested the regulatory pathway for Fast Track approval from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for its leronlimab treatment to provide it to coronavirus patients.

The biotechnology company said it has provided the regulator with a top-line report from its recently completed phase 2 clinical trial of leronlimab in patients with mild-to-moderate coronavirus symptoms, noting the “efficacy and safety results” from the study.

WATCH: CytoDyn submits Phase 2 mild-to-moderate coronavirus patient data to the FDA

“As we recently reported, we are working diligently with several governmental agencies throughout the world to provide leronlimab to patients suffering from [coronavirus]. We believe the statistically significant results for NEWS2 is critical to identifying those patients who are at risk of progressing to a more serious condition. Importantly, in addition to the statistically significant efficacy findings, the safety results from this study were very notable with less SAEs and AEs identified in the leronlimab arm, as compared to placebo”, CytoDyn president and chief executive Nader Pourhassan said in a statement.

“Double-blinded clinical trials that are randomized 2:1, like our study, are very challenging to reach significant results as we demonstrated in a small population of a tough [coronavirus] population in which to show efficacy and safety. We are eager to see the capabilities of leronlimab in our Phase 3 clinical trial for the severe-to-critical patient population. Our enrollment is now at 182 and we are very optimistic we will reach 195 by the end of August”, the CEO added.

The company also announced that David F. Welch, the chair of its compensation committee, has said he will not stand for re-election to the board at the firm’s upcoming annual meeting.

“I understood the potential of CytoDyn some time ago and began investing before joining the board. Our board and management team now function as a positive and cohesive team, which is clearly reflected by the multiple clinical and regulatory opportunities at hand. Now with two licensing agreements in place to bring leronlimab immediately to market upon approval, the company has positioned itself well for patients in need and to reward all of its stakeholders”, Welch said in a statement.

“The entrepreneurial energy that the board, Nader and his team bring everyday makes CytoDyn a very unique environment. It has been a pleasure working with Nader, seeing his vision for countless opportunities for leronlimab and experiencing first hand his relentless drive to make it happen. While I will no longer be a director after the upcoming annual meeting, I will certainly continue to support the Company as a shareholder, advisor and partner”, he added. 

Pourhassan said: “Dave has been a tremendous contributor to our company and I am grateful and honored to have his mentorship. While a director, and several years before becoming a director, he consistently invested in many of our offerings.  He demonstrated his financial support and keen understanding of the trajectory of the many opportunities for leronlimab. We are very pleased he has agreed to continue to provide his sound guidance and counsel to the board.”

Contact the author at [email protected]

Follow him on Twitter @Cal_Proac

Quick facts: CytoDyn Inc.

Price: 5.2 USD

OTCQB:CYDY
Market: OTCQB
Market Cap: $3.11 billion
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