Prothena Biosciences announced that coramitug (previously PRX004) has received Fast Track designation for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM), according to details shared recently in a press release.
Fast Track designation aims to accelerate the drug development process for serious diseases with unmet medical need. The designation involves more frequent meetings and regulatory guidance from the U.S. Food and Drug Administration (FDA), as well as potential eligibility for priority review and accelerated approval.
Coramitug is a humanized monoclonal antibody that clears misfolded transthyretin without impacting the normal form of the protein. Novo Nordisk acquired Prothena’s ATTR program in July 2021. They are currently evaluating coramitug in the Phase 3 CLEOPATTRA trial (NCT07207811).
“We are pleased that the FDA has granted Fast Track Designation for coramitug, a recognition that reflects both the seriousness of ATTR-CM and the significant unmet need that remains for people living with this life-threatening disease, despite standard of care,” said Michelle Lim-Watson, associate portfolio vice president of cardiovascular disease and rare diseases at Novo Nordisk
Read more about ATTR-CM therapies
The CLEOPATTRA trial will assess the safety and efficacy of coramitug in about 1,280 individuals with ATTR-CM. The trial has a planned primary completion date of 2029.
In a previous Phase 2 clinical trial of 60 mg/kg coramitug, participants experienced significant decreases in N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels, a marker of heart damage. Treatment also led to improvements in echocardiograph findings. Of note, over 80% of these individuals were concurrently receiving the standard of care for the disease.
ATTR-CM is caused by the buildup of misshapen transthyretin protein in the heart. Coramitug is designed for individuals with both hereditary and wild-type ATTR-CM. If approved, it may function both as a standalone therapy or as an adjunct to existing treatments.
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