Leyden Labs’ Intranasal PanFlu Antibody Enters the Clinic

BOSTON & LEIDEN, Netherlands--(BUSINESS WIRE)-- Leyden Laboratories B.V., (the “Company” or “Leyden Labs”) announced today the dosing of the first Phase 1 healthy volunteer cohort with a nasal spray containing PanFlu candidate CR9114. CR9114 is a universal anti-hemagglutinin stem human antibody which has been shown to provide broad protection in animal studies against influenza infection and disease.

The Company’s Phase 1 first-in-human trial is a randomized, double-blind, placebo-controlled, dose escalation trial. The Phase 1 trial is designed to evaluate the safety, tolerability, and pharmacokinetics of PanFlu candidate CR9114 through intranasal administration in approximately 75 healthy volunteers. Trial data are expected later this year, after which Leyden Labs plans to initiate subsequent Phase 2 studies of this PanFlu candidate.

“We believe our PanFlu nasal spray could provide protection for both seasonal epidemics and potential future pandemics of influenza,” said Jaap Goudsmit, PhD, MD, Co-Founder and Chief Scientific Officer. “This is not only relevant for people with a weakened immune system and at high risk for hospitalization, but for anyone who risks missing work or school because of flu that keeps them at home or in bed. In case of a severe influenza pandemic, PanFlu could function as an important first line of defense.”

“Amidst the worrisome spread of highly virulent H5N1 avian flu among animals, it’s becoming clearer than ever that society needs a readily available ‘universal response’ ahead of future potential pandemics. Leyden Labs is extremely excited to have reached the first-in-human milestone for PanFlu,” said Koenraad Wiedhaup, Co-Founder and Chief Executive Officer of Leyden Labs.

About Leyden Laboratories B.V.
Leyden Labs is working to free people from the threat of respiratory viruses. Leyden Labs is leveraging its mucosal immunity platform to develop a portfolio of candidates aimed at providing protection against influenza, coronaviruses, and other respiratory viruses through a new class of broadly protective nasal sprays. To learn more, visit www.leydenlabs.com.

About PanFlu candidate CR9114
CR9114, Leyden Labs’ lead product candidate for the PanFlu program, is a human monoclonal antibody that protects against influenza in preclinical models. Leyden Labs holds an exclusive license from Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to develop and commercialize CR9114 for mucosal administration.

Forward-looking statements
This press release contains forward-looking statements, which involve certain risks and uncertainties. These statements can be identified by the use of forward-looking terminology, including the terms “believe,” “would,” “could,” “may,” “will,” “should,” “anticipate,” or “expect,” as well as similar expressions, and include statements concerning the mechanism of action, profile, and timing of clinical trials, of CR9114. Leyden Labs cautions the reader that forward-looking statements are not guarantees of future performance. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. Leyden Labs’ actual results and achievements may materially differ from those predicted by the forward-looking statements as a result of various factors. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this press release. We expressly disclaim any obligation to publicly update the information in this press release, including any forward-looking statements, unless required by law or regulation.

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