Late-stage biotech CytoDyn Inc (CYDY) has announced that is it seeking UK fast track approval for leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications.
The company has provided its Top-line Report from its recently completed Phase 2 clinical trial for patients with mild-to-moderate COVID-19 symptoms to the UK government’s Medicines and Healthcare Products Regulatory Agency (MHRA).
According to CytoDyn, it requested the regulatory pathway for Fast Track based on the efficacy and safety results from the Phase 2 trial.
Nader Pourhassan, CEO of CytoDyn, stated, “As we recently reported, we are working diligently with several governmental agencies throughout the world to provide leronlimab to patients suffering from COVID-19… 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.”
So far the FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first is as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.
In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control.
Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. (See CytoDyn stock analysis on TipRanks).
Shares in CYDY are currently trading up a whopping 207% year-to-date- however they have pulled back 38% so far in August.
Analyst Yi Chen of HC Wainwright is staying sidelined on the stock for now. He reiterated his hold rating after CytoDyn reported positive Phase 2 trial results. “These results show that leronlimab given as a weekly subcutaneous injection in mild-to-moderate COVID-19 patients is safe and can deliver rapid improvement in symptoms associated with the coronavirus infection, in our view” Chen commented on August 17.
The analyst told investors: “In anticipation of both additional clinical data and agency feedback, we reiterate our Neutral rating without a price target.” Chen cited market valuation and volatility as the reasons for removing his prior $4 price target.
Related News:
Gilead Sinks After-Hours As FDA Rejects Arthritis Application
Novavax Launches Covid-19 Vaccine Efficacy Trial In South Africa
Inovio: Valuation and Volatility Keep This Analyst Sidelined
