CytoDyn Inc. ( CYDY Quick Quote CYDY - Free Report) announced that Vyrologix (leronlimab-PRO 140), a CCR5 antagonist, had reached full enrollment in its phase III registrational study for patients with severe-to-critical COVID-19. The 390-patient data will be analyzed in approximately 28 days, with expected results to be announced in mid-January 2021.
However, shares of the company have soared 246% year to date compared with the
industry’s growth of 2.5%.
In October 2020, following the review and recommendation by the Data Safety Monitoring Committee (DSMC) of the data from 195 patients, the company continued the study without modification to achieve the primary endpoint. The DSMC also requested a second review of the data after 75% (or 293) of patients were enrolled and completed a 42-day post-enrollment period. The company concluded it will be far more time efficient to forego the second interim analysis and to analyze the data on 390 patients and to provide final data to the FDA, Health Canada, U.K.’s MHRA, and Philippines FDA, as soon as it is available.
CytoDyn’s phase IIb/IIIstudy will evaluate the efficacy and safety of Vyrologix for patients with severe-to-critical COVID-19 indications. In the study, patients are randomized to receive weekly doses of 700 mg Vyrologix or placebo. Vyrologix and placebo are administered via subcutaneous injection. The primary outcome measured in this study is all-cause mortality at day 28.
Vyrologixis an investigational, humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases and other diseases, including NASH. The FDA has granted a Fast Track designation to Vyrologixfor two potential indications of deadly diseases —one as a combination therapy with HAART for HIV-infected patients and another for metastatic triple-negative breast cancer.
We also note that CytoDyn completed its phase II study (CD10) of Vyrologixfor COVID-19 in the United States, which produced statistically significant results.
Since the Philippine FDA has relaxed the criteria of Emergency Use Authorization (EUA) for any safe drug with any efficacy data, CytoDyn will file its EUA as soon as the presidential order is implemented by the Philippine FDA.
Pfizer Inc. ( PFE Quick Quote PFE - Free Report) and BioNTech SE ( BNTX Quick Quote BNTX - Free Report) announced that the Medicines & Healthcare Products Regulatory Agency (MHRA) in the U.K. granted a temporary authorization for emergency use to their mRNA vaccine (BNT162b2) against COVID-19. This marks the first Emergency Use Authorization following a worldwide phase III study of a vaccine to help fight the pandemic. On December 11, the FDA granted emergency use authorization (EUA) to BNT162b2.
Eli Lilly ( LLY Quick Quote LLY - Free Report) is also making painstaking efforts to develop several potential neutralizing antibodies for the treatment of COVID-19. In November 2020, Lilly’s antibody therapy bamlanivimab was granted an emergency use authorization by the FDA for treating COVID-19.
CytoDyn currently carries a Zacks Rank #4 (Sell).You can see
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