Prothena (PRTA) Pipeline Shows Promise in a Tough AD Market
Prothena Corporation PRTA, a late-stage clinical biotechnology company, has a robust Alzheimer’s Disease (“AD”) pipeline, which spans next-generation antibody immunotherapy, small molecules and vaccines.
The company’s wholly-owned programs include birtamimab for the potential treatment of AL amyloidosis and a portfolio of programs for the potential treatment of AD, including PRX012, which targets Amyloid beta (Aβ) and PRX123, a novel dual Aβ-tau vaccine.
The partnered programs include prasinezumab, in collaboration with Roche RHHBY for the potential treatment of Parkinson’s disease (“PD”) and other related synucleinopathies and programs that target tau (BMS-986446, formerly PRX005), TDP-43 and an undisclosed target (PRX019) in collaboration with Bristol Myers Squibb BMY for the potential treatment of Alzheimer’s disease, amyotrophic lateral sclerosis and other neurodegenerative diseases.
Prothena recently posted third-quarter 2023 earnings of 38 cents per share due to higher collaboration revenues from BMY. The Zacks Consensus Estimate was pegged at a loss of 26 cents per share. In the year-ago quarter, the company reported a loss of 97 cents per share.
Prothena Corporation plc Price and Consensus
Prothena Corporation plc price-consensus-chart | Prothena Corporation plc Quote
Total revenues were $84.9 million in the third quarter, which beat the Zacks Consensus Estimate of $52 million. In July, Bristol Myers exercised an option to obtain exclusive worldwide commercial rights for BMS-986446. Under the terms of the deal, BMY paid $55 million to Prothena for the license. BMY is responsible for the future development, manufacturing and commercialization of the candidate.
The recent focus on the AD space has put the spotlight on companies developing treatments for the same.
While Prothena’s progress with its AD candidates is encouraging, the market is very challenging.
Shares of PRTA lost 42.8% year-to-date compared with the industry’s decline of 23.3%. Shares declined last month after Biogen BIIB and partner Eisai presented new data on the investigational subcutaneous (SC) formulation of AD drug Leqembi.
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Leqembi is an amyloid beta-directed antibody indicated as a disease-modifying treatment for AD in the United States. Data showed subcutaneous formulation clears 14% more plaque than intravenous (IV). However, an increase in amyloid-related imaging abnormalities (“ARIA”), as observed with the SC formulation, was disappointing.
Prothena’s PRX012, too, is a next-generation SC antibody being developed for the treatment of AD that targets a key epitope at the N-terminus of Aβ with high binding potency. Two preclinical studies had earlier showed superior binding characteristics of PRX012, demonstrating a 20-fold higher affinity to Aβ soluble protofibrils when compared with Leqembi and cleared pyroglutamate-modified Aβ at lower concentrations when compared with investigational candidate donanemab.
However, given the higher incidence of ARIA with Leqembi SC, investors seem wary of Prothena’s subcutaneous candidate as well.
In July, the FDA approved Biogen's and partner Eisai’s supplemental biologics license application, supporting the traditional approval of Leqembi, which was initially granted accelerated approval for a similar indication in January.
It remains to be seen how Prothena marches ahead with its AD candidates. 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 filing for the vaccine is anticipated by the end of 2023.
Meanwhile, Roche has completed the enrollment for the phase IIb PADOVA study in patients with early PD (NCT04777331) and top-line data is expected in 2024.
Prothena currently carries 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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