U.S. Food and Drug Administration grants Fast Track Designation to coramitug, an investigational ATTR-CM therapy from Prothena Corporation plc and Novo Nordisk in Phase 3 development.
Written By: Pharmacally Medical News Desk
Prothena Corporation plc announced that the U.S. Food and Drug Administration has granted Fast Track Designation to coramitug, an investigational monoclonal antibody currently in Phase 3 development for transthyretin amyloidosis with cardiomyopathy (ATTR-CM).
The designation is intended to facilitate development and expedite regulatory review for therapies addressing serious conditions with unmet medical need. ATTR-CM is a progressive and life-threatening disease caused by the accumulation of transthyretin amyloid deposits in the heart, leading to declining cardiac function.
Coramitug is designed to selectively bind misfolded transthyretin and promote clearance of amyloid deposits through antibody-mediated mechanisms, while preserving the normal form of the protein.
This dual approach may allow both removal of existing amyloid and prevention of further deposition. It differs from current therapies, which primarily focus on stabilizing or reducing production of transthyretin rather than clearing deposited amyloid.
Novo Nordisk is evaluating coramitug in the ongoing Phase 3 CLEOPATTRA trial (NCT07207811), which is enrolling approximately 1,280 patients with ATTR-CM, with primary completion expected in 2029.
Novo Nordisk obtained global rights to the ATTR amyloidosis program from Prothena in 2021. Under the terms of the agreement, Prothena is eligible to receive up to $1.2 billion in milestone payments, with $150 million received to date.
In a Phase 2 clinical study conducted by Novo Nordisk, coramitug administered at 60 mg/kg reduced NT-proBNP levels, a biomarker of cardiac stress, in patients who were largely receiving standard-of-care treatment. The therapy was also associated with improvements in echocardiographic measures of cardiac function and was generally well tolerated, supporting further clinical investigation.
Prothena CEO Gene Kinney said the Fast Track designation reflects continued progress in advancing coramitug for patients with ATTR-CM.
Michelle Lim-Watson Associate Portfolio Vice President, Cardiovascular Disease and Rare Diseases, U.S. R&D of Novo Nordisk stated that the designation highlights both the seriousness of the disease and the unmet need that remains despite existing treatments, adding that the ongoing Phase 3 trial may help define the therapy’s future role.
Coramitug remains investigational and requires further evaluation in late-stage development.
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