Nuvie Bio Reports Positive Phase 1 Results for Lead Migraine Program

SAN DIEGO—Nuvie Bio, a burgeoning biopharmaceutical company at the clinical stage, has successfully completed its inaugural human trial of NVI-100, the leading investigational medication for acute migraine treatment. The company's focus is on addressing significant unmet medical requirements in the realm of migraines and related neurological conditions.

NVI-100 is a pioneering peptide that acts as an antagonist to the calcitonin gene-related peptide (CGRP) receptor. This innovative treatment is administered through an easy-to-use autoinjector, intended for swift relief from migraines. The Phase 1 trial, conducted with healthy participants, demonstrated that NVI-100 is well-tolerated and achieves rapid, consistent plasma concentration. Plans are underway for Nuvie Bio to submit an Investigational New Drug (IND) application for NVI-100 within the year, aiming to commence a Phase 2 clinical trial.

Pierre Rivière, Ph.D., who is both a co-founder and CEO of Nuvie Bio, highlighted the importance of this development: “We are pioneering a quickly absorbed subcutaneous CGRP receptor antagonist to provide rapid relief to millions dissatisfied with current migraine therapies. The Phase 1 study results for NVI-100 are promising, suggesting it could offer a new level of efficacy combined with tolerability for acute migraine treatment."

Richard B. Lipton, M.D., a Professor and Vice Chair of Neurology at Albert Einstein College of Medicine as well as the director of the Montefiore Headache Center, expressed his enthusiasm: “Recent years have brought remarkable advancements in migraine treatment. NVI-100 could potentially revolutionize acute treatment by offering rapid migraine relief through subcutaneous administration, with high tolerability."

Nuvie Bio's inception involved the collaboration of Pierre Rivière, Ph.D., serving as CEO; Frank Porreca, Ph.D., as Chief Scientific Officer; and David Dodick, M.D., who chairs the scientific advisory board. Their combined expertise encompasses both foundational and clinical research in migraine and peptide therapeutics. They are supported by a senior management group that has played key roles in past therapeutic advancements in the field of migraine treatment.

Originally identified by Ferring Pharmaceuticals, NVI-100, also known by other designations such as AXN-001 and FE205030, is now under Nuvie Bio's exclusive global development and commercialization rights.

Migraine is recognized as the second leading cause of neurological disability worldwide, disproportionately affecting women with a prevalence ratio of approximately three to one compared to men. The condition affects over a billion individuals globally, contributing to more than 45 million disability-adjusted life-years (DALYs), a metric representing the loss of the equivalent of one year of complete health. Despite significant progress in migraine treatment, there remains a demand for more effective acute treatment options that offer swift and tolerable relief.

Nuvie Bio positions itself as a trailblazer in the field of neuroscience, committed to enhancing the quality of life for those suffering from migraines and other neurological disorders. The company's flagship investigational drug, NVI-100, is a unique water-soluble peptide CGRP receptor antagonist, delivered subcutaneously via an autoinjector for acute migraine treatment. Designed to provide rapid relief without compromising tolerability, Nuvie Bio aims to eliminate the dilemma between efficacy and patient comfort. The executive team leading Nuvie Bio brings extensive experience in neuroscience, particularly in the development and commercialization of migraine treatments, and they are backed by a scientific advisory board composed of leading experts in migraine and brain disorders.