Biohaven Pharmaceutical Holding Co Ltd (NYSE:BHVN) has announced that it recently received a letter from the Food and Drug Administration giving it the green light for BHV-3241’s Phase 3 Clinical Trial.
BHV-3241 is Biohaven’s developmental treatment for myeloperoxidase (MPO) inhibitor that the company has been working on, as a multiple system atrophy (MSA) treatment. The biopharma announced that it received the letter with the notice to continue with BHV-3241’s clinical investigation. The letter came after the company reactivated an investigational new drug (IND) application for the MPO inhibitor. AstraZeneca plc (NYSE: AZN) initially filed for the IND before dropping it.
“We are very pleased to report the FDA’s acceptance of the IND for BHV-3241 for the treatment of MSA,” stated Biohaven CEO, Vlad Coric.
BHV-3241 might be a game changer for MSA patients
Coric also added that the company is optimistic about BHV-3241’s potential to become the first effective MSA treatment. Biohaven plans to kick off its Phase 3 trial of the treatment in Q3 this year. Although MSA is rare, patients diagnosed with it find themselves facing a scary situation because it is characterized by rapid progression and it is fatal. The degenerative condition leads to death within 6 to 10 years from the time the patient falls ill.
MSA has characteristics that are similar to those of Parkinson’s disease such as rigid muscles, poor balance, tremors, and slow movement. Patients may also experience cerebellar ataxia and their involuntary functions may not work properly. For example, one may lose bladder function and blood pressure control. MSA does not have a cure and patients only rely on therapies that help ease or manage the symptoms.
Biohaven’s executive director of neurology Irfan Qureshi stated that MSA patients urgently require new therapies. There is thus a lot of hope riding on BHV-3241 because it has potential as an MSA treatment. The therapy is designed to inhibit myeloperoxidase enzyme activity, thus preventing neuroinflammation and oxidative stress.
Qureshi noted that the results from AstraZeneca’s Phase 2 clinical trial indicate that BHV-3241 might have the capacity to stock MSA’s progression in patients. However, treatment through BHV-3241 has to be done dose-dependently where doses are measured through the Unified MSA Rating Scale.