NEW HAVEN: Two New Haven based biotechs, Melinta Therapeutics [Nasdaq:MLNT] and Biohaven [NYSE:BHVN] have both just begun new clinical trials.
Melinta Therapeutics, Inc. which has developed the FDA approved antibiotic Baxelda, to treat MRSA and other skin infections, has initiated a Phase 2 clinical study of topical Radezolid for the treatment of mild-to-moderate acne vulgaris.
The Melinta study will enroll approximately 48 individuals with moderate-to-severe facial acne vulgaris. The company hopes to demonstrate that the twice daily application will create at least an “almost clear” condition. The study is expected to complete enrollment in the second half of 2018.
Sue Cammarata, Melinta’s chief medical officer, said “Radezolid for acne vulgaris has progressed extremely well though preclinical and clinical development. With resistance to currently available topical antibiotics rising, we believe that Radezolid could be an important treatment option.”
Melinta developed Radezolid but has entered into a development agreement with an undisclosed party for “topical indications.” According to the company, “the deal structure provides Melinta with a potential long-term financial return and affords Melinta the opportunity to participate in radezolid’s future development and commercialization.”
New Haven based, Biohaven Pharmaceuticals, Inc., has also just begun a new clinical trial enrolling its first subject in a bioequivalence study [ biosimilar]designed to demonstrate the “pharmacokinetic equivalence of sublingual BHV-0223 compared to Rilutek (riluzole),” for the treatment of ALS [ Lou Gehrig’s Disease]. Riluzole was first approved for a non-curing treatment of ALS is 1995 and became available as a generic drug in 2003 and is marketed by multiple companies.
According to Biohaven its drug [BHV-0223] “is an innovative sublingually administered and orally dissolving tablet (ODT) formulation of riluzole, a glutamate modulating agent, which is designed to advance beyond the current limitations of riluzole tablets.
Adding, “riluzole tablets are FDA-approved for ALS, they may be difficult to administer in ALS patients, who often have trouble swallowing.”
Vlad Coric, M.D., Chief Executive Officer of Biohaven, commented, "We are excited to advance the unique BHV-0223 Zydis® orally dissolving tablet (ODT) formulation into the clinic. If positive, the current study will establish the bioequivalence of sublingually administered BHV-0223."