Nuvie Bio, a new clinical-stage biopharmaceutical company dedicated to addressing the most pressing unmet medical needs in migraine and related neurological diseases, announced completion of a first-in-human trial with NVI-100, the company’s lead investigational drug for the acute treatment of migraine.
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NVI-100 is a first-in-class water-soluble peptide antagonist for the calcitonin gene-related peptide (CGRP) receptor delivered via a patient-friendly autoinjector for the acute treatment of migraine. The Phase 1 study in healthy volunteers has shown that NVI-100 is well-tolerated and achieves rapid, high and consistent plasma levels. Nuvie Bio plans to file an Investigational New Drug (IND) application for NVI-100 later this year, clearing the way for the start of its Phase 2 clinical trial.
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“We are developing the first rapidly absorbed subcutaneous CGRP receptor antagonist, with the goal to provide rapid relief from migraine to millions of people who are not satisfied with existing therapies,” said Pierre Rivière, Ph.D., co-founder and CEO of Nuvie Bio. “We are extremely pleased with the results of the NVI-100 Phase 1 study. The human pharmacokinetics data support that NVI-100 is the first CGRP receptor antagonist with the potential to deliver fast, high and consistent efficacy, which combined with the tolerability associated with this clinically validated mechanism of action, could profoundly transform the acute treatment of migraine.”
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“It is an exciting time to be involved in caring for people with migraine because of the significant advancements in treatments we have seen in recent years,” said Richard B. Lipton, M.D., Professor and Vice Chair of Neurology, Albert Einstein College of Medicine, and director, Montefiore Headache Center. “NVI-100 has the potential to be the next breakthrough in acute treatment, providing rapid relief of migraine through subcutaneous administration with the high tolerability we associate with CGRP-targeted therapies.”
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Nuvie Bio was co-founded by Pierre Rivière, Ph.D., CEO; Frank Porreca, Ph.D., CSO; and David Dodick, M.D., chair of the scientific advisory board. Their combined expertise spans basic and clinical science in migraine and peptide therapeutics research and development. Working alongside them is a senior management team that has significantly contributed to previous therapeutic innovations in migraine.
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Source – businesswire
