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Prothena (PRTA) IND Application Gets FDA Clearance for AD

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Prothena Corporation plc (PRTA - Free Report) announced that the FDA has cleared the investigational new drug (IND) application for pipeline candidate PRX012 for the treatment of Alzheimer’s disease (AD).

PRX012 is a potential best-in-class anti-amyloid beta (Aβ) antibody. Prothena has initiated the phase I single ascending dose (SAD) study to evaluate the safety, tolerability, immunogenicity and pharmacokinetics of PRX012 in both healthy volunteers and patients with AD.

In this phase I SAD study, healthy volunteers and patients will be randomized to receive a single subcutaneous injection of either PRX012 or placebo.

Prothena expects to initiate the phase I multiple ascending dose study by year-end 2022.

Data from preclinical studies showed that PRX012 binds to beta amyloid plaques and oligomers with high avidity, enabling effective levels of Aβ plaque occupancy at relatively lower dose ranges, which are optimal for subcutaneous delivery.

The company’s shares have declined 25.2% in the year so far compared with the industry’s fall of 13.2%.


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The FDA approval of Biogen’s (BIIB - Free Report) AD drug, Aduhelm, in June 2021 has put the spotlight on companies with promising AD candidates in their pipeline. Prothena is one of the frontrunners.

Prothena is advancing an early-stage pipeline of programs for a number of potential neurological indications with Bristol Myers (BMY - Free Report) .  This includes PRX005 — a potential treatment for AD — is an investigational antibody that targets tau, a protein implicated in diseases including AD, frontotemporal dementia, progressive supranuclear palsy, chronic traumatic encephalopathy and other tauopathies. The company has received an $80 million option payment from Bristol Myers to execute the U.S. license agreement in 2021.  A phase I study was initiated in 2021, and top-line data is expected in 2022.

The company is also developing a dual Aβ-Tau vaccine — a potential prevention and treatment for AD — to target key epitopes within Aβ and tau proteins for promoting amyloid clearance as well as blockade pathogenic tau interaction. An IND for the vaccine is anticipated in 2023.

However, the uptake of Biogen’s Aduhelm has been slow due to limited patient access amid a lack of clarity on Aduhelm reimbursement. 

Hence, there is a long way to go for companies like Prothena in the AD space.

Prothena currently carries a Zacks Rank #4 (Sell).

A better-ranked stock in the biotech sector is Vertex Pharmaceuticals (VRTX - Free Report) which currently carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

The consensus estimate for Vertex’s 2022 earnings has increased $1.13 over the past 60 days to $14.52. Shares of VRTX have gained 16.4% in the past year.


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