Prothena Announces Achievement of $50 Million Clinical Milestone in ATTR Amyloidosis with Cardiomyopathy

Source
BioSpace.com
  • Coramitug is a potential first-in-class amyloid depleter antibody for the treatment of ATTR amyloidosis with cardiomyopathy1-3
  • Prothena has now earned $150 million to date of the $1.2 billion total eligible milestone payments from Novo Nordisk

DUBLIN--(BUSINESS WIRE)--$PRTA #Prothena--Prothena Corporation plc (NASDAQ:PRTA) today announced that the Company earned a $50 million milestone payment from Novo Nordisk related to the achievement of a prespecified enrollment target in the ongoing Phase 3 CLEOPATTRA clinical trial evaluating coramitug (formerly PRX004), a potential first-in-class amyloid depleter antibody, for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM).

Novo Nordisk is evaluating coramitug in the ongoing Phase 3 CLEOPATTRA clinical trial in approximately 1280 participants with ATTR-CM with primary completion expected in 2029 (NCT07207811).

Novo Nordisk gained full worldwide rights to the intellectual property and related rights of the ATTR amyloidosis business and pipeline it acquired from Prothena in July 2021. Under the terms of the acquisition agreement, Prothena is eligible to receive up to $1.2 billion upon achievement of clinical development and sales milestones, including $150 million earned to date.

About Coramitug (formerly PRX004)

Coramitug (formerly PRX004) is an investigational antibody designed to deplete amyloid associated with disease pathology in hereditary and wild type ATTR amyloidosis, without affecting the native, normal tetrameric form of the protein1-3. Coramitug’s proposed mechanism of action is to deplete both the deposited amyloid to improve organ function and circulating non-native TTR to prevent further organ deposition1-3. This differentiated depleter mechanism of action could be developed as a monotherapy approach to ATTR amyloidosis and might also complement existing therapeutic approaches which either stabilize or reduce production of the native TTR tetramer3.

In a Phase 2 clinical trial conducted by Novo Nordisk, coramitug 60 mg/kg significantly reduced NT-proBNP in a patient population predominantly in which the vast majority (>80%) were already receiving standard of care treatment for ATTR-CM. Furthermore, compared with placebo, coramitug was associated with improvements in multiple echocardiographic parameters of cardiac function, and was well-tolerated in participants with ATTR-CM. These findings support the potential of coramitug as an amyloid-clearing immunotherapy for ATTR-CM and provide a rationale for additional clinical investigation of coramitug for the treatment of patients with ATTR-CM4.