Shares of Prothena Corporation PRTA have gained 29% in the past one year against the industry’s loss of 15.9%.
The recent spotlight on the Alzheimer’s Disease (AD) space has put focus on companies developing treatments for the same.
Prothena’s promising AD pipeline spans next-generation antibody immunotherapy, small molecules and vaccines.
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The company recently announced new preclinical data from its PRX012 program, a potential best-in-class anti-amyloid beta (Aβ) product candidate in development for the treatment of AD, at the 2023 International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders (AD/PD) in Gothenburg, Sweden.
Data supported the profile of PRX012 which is designed to target all aggregated forms of amyloid beta with high binding potency. PRX012 demonstrated 20-fold higher affinity to amyloid beta soluble protofibrils when compared to recently approved Leqembi (lecanemab). The FDA had earlier granted Fast Track designation to PRX012 for the treatment of AD. Prothena has initiated phase I single ascending dose (SAD) and multi ascending dose (MAD) studies in healthy volunteers and patients with AD and top-line data is expected by 2023 end.
We note that FDA granted accelerated approval to Biogen BIIB and patner Eisai’s Leqembi in January 2023 to treat early AD.
The FDA’s approval of Biogen’s and Eisai’s other AD drug, Aduhelm, in June 2021 put this space in the spotlight. The euphoria surrounding Aduhelm, however, faded as the drug witnessed a slow launch due to reimbursement issues as its efficacy was scrutinized.
AD is a progressive, fatal disease of the brain characterized by a decline in memory, language and other thinking skills, as well as changes in mood and behavior.
Another candidate, PRX005, is being developed in collaboration with Bristol Myers Squibb, is an investigational antibody that specifically targets a key epitope within the microtubule binding region (MTBR) of tau, a protein implicated in diseases including AD, frontotemporal dementia (FTD), progressive supranuclear palsy (PSP), chronic traumatic encephalopathy (CTE), and other tauopathies.
Topline data from the phase I SAD study announced in January 2023 showed single doses of PRX005 across three dose cohorts were generally safe and well tolerated, and the candidate achieved the primary objective of the study. The phase I MAD study is ongoing.
The company is also developing a dual Aβ-Tau vaccine, PRX123, a potential prevention and treatment for AD — to target key epitopes within Aβ and tau proteins to promote amyloid clearance and block pathogenic tau interaction.
An Investigational New Drug application for the vaccine is anticipated by the year end.
The successful development of any of these candidates will be a significant boost to the company.
Other candidates in Prothena’s pipeline include prasinezumab, developed in collaboration with Roche RHHBY, for the treatment of Parkinson’s disease.
A phase IIb PADOVA study in patients with early Parkinson’s disease is being conducted by Roche and top line data is expected in 2024.
It is also evaluating birtamimab, a potential treatment for AL amyloidosis. It reached a Special Protocol Assessment agreement with the FDA and initiated a confirmatory phase III AFFIRM-AL study of birtamimab in Mayo Stage IV patients with AL amyloidosis in 2021. Results are expected in 2024.
Prothena currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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