Receive our newsletter – data, insights and analysis delivered to you
  1. News
March 12, 2021

CytoDyn doses subjects in long-haulers Covid-19 therapeutic trial 

CytoDyn has enrolled and dosed 20 subjects in the first ten days of its Phase II trial of Vyrologix (leronlimab-PRO 140) in patients with Covid-19 long-haulers symptoms. 

CytoDyn has enrolled and dosed 20 subjects in the first ten days of its Phase II trial of Vyrologix (leronlimab-PRO 140) in patients with Covid-19 long-haulers symptoms.

A CCR5 antagonist, leronlimab possesses the potential for various therapeutic indications.

The randomised, double-blind, placebo-controlled study will analyse the efficacy and safety of leronlimab in participants with prolonged Covid-19 symptoms called long-haulers.

CytoDyn intends to enrol 50 patients in the trial. Each subject will be given eight weekly doses of leronlimab and followed up for four weeks of safety evaluation.

The endpoint measure will be at day 56, while the trial results are anticipated by June this year.

CytoDyn Clinical Development vice-president Christopher Recknor said: “This trial represents a potential solution for many patients with post-acute sequalae from Covid-19 (PASC) known as long-haulers where currently no treatment is available.

Content from our partners
Why this global life sciences COO believes relocation to Charleston, SC, was key to achieving next-level success
Patient-centric pharma logistics: How CRYOPDP delivers hope worldwide
Why Asia-Pacific is the next frontier for decentralized clinical trials

“Patients in the trial have had lingering symptoms for over 12 weeks and they need help. We are looking at sophisticated biomarkers that will help us identify who benefits and why.

“In our CD10 Covid mild-to-moderate trial with leronlimab, we noted a reduction in adverse events or symptoms including fatigue, diarrhoea, chest pain, fatigue, muscle weakness, and anxiety in treated versus placebo groups.”

Enrolment is progressing in the Phase II trial for Covid-19 long-haulers in various hospitals and clinics throughout the US.

CytoDyn president and CEO Nader Pourhassan said: “With strong CD12 results, NASH and long-hauler results not too far away, along with our BLA submission for HIV coming up, we are more confident than ever about the future of leronlimab for many indications.

“We are also equally very excited about our cancer trial and ready to file for a Breakthrough Therapy Designation meeting with the FDA this month.”

Related Companies

Topics in this article:
NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU