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March 15, 2021updated 12 Jul 2022 11:22am

LoA Update: Regeneron’s chance at an FDA nod for its cat allergy treatment for mild asthma patients jumps 8 points on Phase II data

Regeneron Pharmaceuticals’ Phase II antibody cocktail REGN1908-1909 in cat-allergic patients with mild asthma had an eight-point increase in its FDA likelihood of approval (LoA) to 18% as of 2 March.

By Reynald Castañeda

Regeneron Pharmaceuticals’ Phase II antibody cocktail REGN1908-1909 in cat-allergic patients with mild asthma had an eight-point increase in its FDA likelihood of approval (LoA) to 18% as of 2 March. The surge is due to the proof-of-concept Phase II REGN1908-1909 trial meeting its primary efficacy endpoint, as per a 27 February media release.

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Prior to Phase II data reveal, REGN1908-1909 previously had an LoA of 10%, according to GlobalData analysis using a combination of machine learning and its proprietary algorithm. The 56-patient, placebo-controlled Phase II trial investigated single-dose, 600mg REGN1908-1909, which is administered subcutaneously. The trial met its primary endpoint of preventing early asthma reactions (EAR) with a 12-week assessment period. EAR is defined as a ≥20% decline in forced expiratory volume over one second (FEV1).

REGN1908-1909 features two monoclonal IgG antibodies designed to bind and block Fel d 1 allergens, and so prevents the allergen from triggering endogenous antibodies that causes allergies. Fel d 1 is the major allergen in cat dander. Regeneron has a $50.75bn market cap.

Reynald Castaneda is an Associate Editor for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.

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