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Biohaven Pharmaceuticals has announced that it has signed an exclusive global licensing agreement with AstraZeneca through its subsidiary Biohaven Therapeutics to develop and promote the new drug BHV3241 (formerly AZD3241). The drug is an oral myelin peroxidase (MPO) inhibitor that AstraZenecon has advanced to Phase 2 clinical. Biohaven plans to conduct Phase 3 clinical trials of the candidate for the treatment of multisyscular atrophy (MSA). This is a rare, rapidly progressing and deadly neurodegenerative disease that currently has no effective treatment.
MSA is an aggressive neurodegenerative disease that affects the autonomic nervous system (the nervous system that controls unconscious movements such as blood pressure or digestion) and exercise, showing a combination of symptoms. These symptoms reflect the gradual loss and death of different types of nerve cell function in the brain and spinal cord. The rare disease may affect between 15,000 and 50,000 Americans. Symptoms tend to appear in the patient's 50s and progress rapidly within 5 to 10 years, leading to a gradual loss of motor function and eventually being bedridden. MSA patients often develop pneumonia in the late stages of the disease and may suddenly die of heart or breathing problems. Although the drug can treat some of msA's symptoms, there is currently no cure for the disease, and these patients are in dire need of an effective treatment to alleviate the disease.
MCO is a key driver of oxidation and inflammation, which increases significantly in a range of brain diseases. Inhibiting MPA activity is a promising strategy for treating neuroinstitive and neurodegenerative diseases, including MSA. The study found that elevated MPO levels were also associated with multiple sclerosis and Alzheimer's disease.
BHV3241 is a research MCO inhibitor. Preliminary results from Phase 2a trials completed by AstraZeneta in MSA patients showed an improvement in the main efficacy measured by the Unified MSA Scale. After 12 weeks of treatment, the placebo group's patient score dropped by 4.6 points (SE s 1.1, n s 17), while the score for patients using 300 mg BHV3241 twice a day dropped by 3.7 points Scores (SE s 1.2, n s 17) and patient scores decreased by 2.6 points (SE s 1.4, n s 18) using 600 mg BHV3241 twice daily. Other measurements, such as the Comprehensive Autoimperia Score and msA Quality of Life Scale, were also improved accordingly. These clinical findings are consistent with the neuroscientist effects of BHV3241 observed in animal models. In phase 2a trials, BHV3241 significantly reduced MMO activity in human blood, a biomarker that binds the drug to its target. In addition, studies have shown that the BHV3241 is safe and well-to-do.
through the licensing of BHV3241, Biohaven has been able to expand its innovative, late-stage candidate portfolio for the treatment of neuro and mental illness adaptations. Under the terms of the agreement, AstraZeneta will receive an advance payment from Biohaven and will be eligible for further development and promotion milestone payments, as well as sales share. In addition to cardiovascular disease, Biohaven will seek and promote all therapeutic adaptations to BHV3241.
Vlad Coric, chief executive of Biohaven, said: "We are delighted that BHV3241 has the potential to become an MPO inhibitor for 'first-in-class' and a new drug for MSA. Patients affected by this severe neurological disease are in urgent need of treatment. We believe that in AstraZenecon's Phase 2a study, early signals observed at a 12-week point in time provide a strong reason to initiate a long-term, definitive trial to determine its efficacy and safety in MSA patients. Licensing this late-stage product is not only a good strategic complement to our existing portfolio, but also underscores Biohaven's commitment to providing improved therapies for patients with disabling neurological disorders. Dr
. Werner Poewe, a professor in the Department of Neurology at Innsbruck Medical University in Austria and an expert in the field of MSA, commented: "We are very encouraged by the initial clinical efficacy signals observed in the Phase 2a study, including uniform MSA scales and other measurements. These data, combined with favorable safety, and evidence that BHV3241 reduces intracellular aggregation of α-synthesic nucleoproteins, inhibits small glial cell activation, and saves neurodegeneration in MSA animal models, support our view that BHV3241 has the potential to be a therapy for improving MSA. Mr. Kumar Srinivasan, Vice President of Science Partners and Alliances, IMED Biotechnology,
AstraZene, said, Biohaven has assembled an experienced team that we believe will provide the best opportunity for BHV3241 to be evaluated in patients with debilitating neuropsynaia, while also creating potential future value for AstraZenecon. (Bio Valley)