Emerging Clinical-Stage Neuroscience Company Nuvie Bio Announces Positive Phase 1 Data with its Lead Migraine Program

- Nuvie Bio’s proprietary peptide technology is being used to create transformative products for the most significant unmet medical needs of people with migraine

- The company is led by a team of experts with decades of neuroscience and migraine product development and commercialization experience and supported by a scientific advisory board of preeminent neurologists and headache specialists

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.

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.

“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.”

“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.”

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.

Originally discovered by Ferring Pharmaceuticals, NVI-100 (also known as AXN-001, FE205030) is now under exclusive worldwide development and commercialization rights by Nuvie Bio.

About Migraine

Migraine is the second most disabling neurological disease globally, disproportionately affecting women (about 3:1 female:male prevalence ratio). Migraine impacts over one billion people worldwide and accounts for over 45 million disability-adjusted life-years (DALYs). One DALY represents the loss of the equivalent of one year of full health. Despite recent advancements in migraine treatment, patients and healthcare providers continue to seek better acute treatments, particularly those offering “speed to relief that is tolerable.”

About Nuvie Bio

Nuvie Bio is a clinical-stage biopharmaceutical company on the forefront of innovation in neuroscience. Meaning "New Life," Nuvie Bio’s mission is to offer a better life to millions of people impacted by migraine and related neurological diseases. Nuvie Bio’s lead investigational drug, NVI-100, is a first-in-class water-soluble peptide CGRP receptor antagonist to be given subcutaneously by autoinjector for the acute treatment of migraine. NVI-100 is designed to deliver fast relief that patients can tolerate, eliminating the need to choose between efficacy and tolerability. The company is led by an executive team with decades of neuroscience and migraine product development and commercialization experience and is supported by a scientific advisory board of preeminent experts in migraine and brain disorders. For more information, visit www.nuviebio.com.

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