U.K. MHRA Clears CytoDyn to File its BLA for Leronlimab as One Injection per Week for Combination HIV Therapy - Seite 2
An important recent discovery of leronlimab is the ability to cross the blood-brain barrier to treat diseases where CCR5 antagonism may benefit the central nervous system. In a study of HIV in macaques, it was determined that the administration of leronlimab resulted in approximately 70-75% CCR5 receptor occupancy in the frontal lobes, parietal lobes, and cerebellum. Independent research on CCR5 antagonism in central nervous system pathology has shown promise in various disease processes, including multiple sclerosis, Parkinson's disease, CNS tumors, traumatic brain injury, and stroke recovery.
About Coronavirus Disease 2019
CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a double-blinded, randomized clinical trial for mild-to-moderate patients in the U.S. which produced statistically significant results for NEWS2. Enrollment continues in its Phase 2b/3 randomized clinical trial for the severe-to-critically ill COVID-19 population in several hospitals throughout the U.S.; an interim analysis on the first 195 patients was conducted mid-October.
CytoDyn is currently conducting its Phase 2b/3 COVID-19 trial for patients with severe-to-critical indications in numerous hospitals and clinics across the U.S., which are identified on the Company’s website under the “Clinical Trial Enrollment” section of the homepage.
About Leronlimab (PRO 140)
The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first indication is a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. 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. Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).
In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.