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Prothena (PRTA) Skyrockets 88.7% in 12 Months: Here's Why
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Shares of late-stage clinical biotechnology Prothena (PRTA - Free Report) surged 88.7% in a year against the industry’s decline of 12.6%.
The significant surge is mostly attributable to Prothena’s robust Alzheimer’s Disease (AD) pipeline, which spans next-generation antibody immunotherapy, small molecules and vaccines.
Image Source: Zacks Investment Research
The recent spotlight on the AD space has put the spotlight on companies developing treatments for the same.
In July, the FDA approved Biogen's (BIIB - Free Report) and partner Eisai’s supplemental biologics license application, supporting the traditional approval of their AD drug Leqembi (lecanemab). The drug was initially granted accelerated approval for a similar indication in January. The traditional approval is based on data from Eisai’s late-stage global Clarity AD clinical study, wherein Leqembi met its primary endpoint and all key secondary endpoints with statistically significant results and confirmed the clinical benefit of Leqembi.
The approval raised investors’ hopes for companies like Prothena with AD candidates in their pipeline.
The pipeline progress has been encouraging. In July 2023, Prothena shared data on three investigational product programs for the treatment and prevention of AD, PRX005, PRX012 and PRX123, at the Alzheimer’s Association International Conference 2023 (AAIC).
PRX005, a novel anti-MTBR tau humanized monoclonal antibody, is being evaluated in a phase I study.
The results of the single ascending dose (SAD) portion of the study showed that all three dose level cohorts (low, medium, high) of PRX005 were considered generally safe and well tolerated. The study met the primary objective of the SAD portion and supported the evaluation of doses in the multiple ascending dose portion of the ongoing study. PRX005 also met key pharmacokinetic and immunogenicity secondary endpoints. Plasma drug concentrations of PRX005 increased in a dose-proportional manner.
Prothena also announced that Bristol Myers Squibb (BMY - Free Report) exercised its $55 million option under the global neuroscience research and development collaboration to obtain the exclusive worldwide commercial rights for PRX005. Bristol Myers Squibb will be responsible for the development, manufacturing and commercialization of PRX005.
PRX123, a wholly-owned potential first-in-class dual Aβ/tau vaccine designed for the treatment and prevention of AD, is a dual-target vaccine targeting key epitopes within the N-terminus of amyloid beta (Aβ) and MTBR-tau designed to promote amyloid clearance and block the transmission of pathogenic tau.
Preclinical results showed that a PRX123 vaccine surrogate elicited robust antibody responses that bound with high avidity to Aβ plaques in AD brain ex vivo and significantly reduced Aβ brain plaques, representing the first time that a dual target vaccine for AD has been shown to reduce pathology in a transgenic mouse model of AD pathology. An investigational new drug application filing is expected by 2023-end.
PRX012, a wholly-owned, potential best-in-class, next-generation subcutaneous antibody for the treatment of AD, targets a key epitope at the N-terminus of Aβ with high binding potency.
Two preclinical studies 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 Eli Lilly’s (LLY - Free Report) investigational candidate donanemab.
The successful development of any of these candidates will be a significant boost to Prothena.
Shares of the company skyrocketed in September 2022 as well, after Biogen and Eisai announced positive data on Leqembi.
Other candidates in Prothena’s pipeline include prasinezumab, developed in collaboration with Roche 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.
Meanwhile, Eli Lilly also presented results from the phase III TRAILBLAZER-ALZ 2 study at the AAIC that showed treatment with donanemab significantly slowed cognitive and functional decline in patients with early symptomatic AD (either mild cognitive impairment or mild dementia due to AD), thereby lowering the risk of disease progression.
Image: Bigstock
Prothena (PRTA) Skyrockets 88.7% in 12 Months: Here's Why
Shares of late-stage clinical biotechnology Prothena (PRTA - Free Report) surged 88.7% in a year against the industry’s decline of 12.6%.
The significant surge is mostly attributable to Prothena’s robust Alzheimer’s Disease (AD) pipeline, which spans next-generation antibody immunotherapy, small molecules and vaccines.
Image Source: Zacks Investment Research
The recent spotlight on the AD space has put the spotlight on companies developing treatments for the same.
In July, the FDA approved Biogen's (BIIB - Free Report) and partner Eisai’s supplemental biologics license application, supporting the traditional approval of their AD drug Leqembi (lecanemab). The drug was initially granted accelerated approval for a similar indication in January. The traditional approval is based on data from Eisai’s late-stage global Clarity AD clinical study, wherein Leqembi met its primary endpoint and all key secondary endpoints with statistically significant results and confirmed the clinical benefit of Leqembi.
The approval raised investors’ hopes for companies like Prothena with AD candidates in their pipeline.
The pipeline progress has been encouraging. In July 2023, Prothena shared data on three investigational product programs for the treatment and prevention of AD, PRX005, PRX012 and PRX123, at the Alzheimer’s Association International Conference 2023 (AAIC).
PRX005, a novel anti-MTBR tau humanized monoclonal antibody, is being evaluated in a phase I study.
The results of the single ascending dose (SAD) portion of the study showed that all three dose level cohorts (low, medium, high) of PRX005 were considered generally safe and well tolerated. The study met the primary objective of the SAD portion and supported the evaluation of doses in the multiple ascending dose portion of the ongoing study. PRX005 also met key pharmacokinetic and immunogenicity secondary endpoints. Plasma drug concentrations of PRX005 increased in a dose-proportional manner.
Prothena also announced that Bristol Myers Squibb (BMY - Free Report) exercised its $55 million option under the global neuroscience research and development collaboration to obtain the exclusive worldwide commercial rights for PRX005. Bristol Myers Squibb will be responsible for the development, manufacturing and commercialization of PRX005.
PRX123, a wholly-owned potential first-in-class dual Aβ/tau vaccine designed for the treatment and prevention of AD, is a dual-target vaccine targeting key epitopes within the N-terminus of amyloid beta (Aβ) and MTBR-tau designed to promote amyloid clearance and block the transmission of pathogenic tau.
Preclinical results showed that a PRX123 vaccine surrogate elicited robust antibody responses that bound with high avidity to Aβ plaques in AD brain ex vivo and significantly reduced Aβ brain plaques, representing the first time that a dual target vaccine for AD has been shown to reduce pathology in a transgenic mouse model of AD pathology. An investigational new drug application filing is expected by 2023-end.
PRX012, a wholly-owned, potential best-in-class, next-generation subcutaneous antibody for the treatment of AD, targets a key epitope at the N-terminus of Aβ with high binding potency.
Two preclinical studies 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 Eli Lilly’s (LLY - Free Report) investigational candidate donanemab.
The successful development of any of these candidates will be a significant boost to Prothena.
Shares of the company skyrocketed in September 2022 as well, after Biogen and Eisai announced positive data on Leqembi.
Other candidates in Prothena’s pipeline include prasinezumab, developed in collaboration with Roche 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.
Meanwhile, Eli Lilly also presented results from the phase III TRAILBLAZER-ALZ 2 study at the AAIC that showed treatment with donanemab significantly slowed cognitive and functional decline in patients with early symptomatic AD (either mild cognitive impairment or mild dementia due to AD), thereby lowering the risk of disease progression.
Prothena currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.