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Roche's (RHHBY) AD Drug Gets Breakthrough Therapy Status

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Roche RHHBY recently announced that the FDA has granted a Breakthrough Therapy Designation to its pipeline candidate, gantenerumab for the treatment of people with Alzheimer’s disease (AD).

This designation accelerates the development and review of drugs and treatments that are intended to treat serious or life-threatening conditions with preliminary evidence indicating that they may demonstrate a substantial improvement over available therapies having full FDA approval.

Gantenerumab is an anti-amyloid beta antibody developed for subcutaneous administration.  The designation was based on data that showed gantenerumab significantly reduced brain amyloid plaque, a pathological hallmark of AD, in the ongoing SCarlet RoAD and Marguerite RoAD open-label extension studies, as well as other studies.

The data observed from these studies have been incorporated into the optimized design of two ongoing parallel, global, placebo-controlled and randomized phase III studies — GRADUATE 1 and 2. The studies are evaluating gantenerumab in more than 2,000 participants for more than two years and are expected to be completed in the second half of 2022.

Spotlight on AD Treatments

The FDA approval of Biogen’s BIIB and Eisai’s AD drug, Aduhelm (aducanumab), in June 2021 has put the spotlight on AD treatments. 

AD is a progressive, fatal disease of the brain, which is characterized by a decline in memory, language and other thinking skills along with behavioral changes. AD is the most common form of dementia. Approximately 10 million people globally are diagnosed with AD each year.

However, Biogen recently mentioned that the launch of Aduhelm is facing some near-term launch challenges. Given the rising cases and lack of treatments, quite a few companies have invested millions and billions of dollars to successfully develop a treatment for the same but most have failed.

Nevertheless, most of the bigwigs and smaller pharma/bioetechs continue to develop treatments for this promising yet challenging space. Biogen and partner Eisai recently announced that the latter has initiated a rolling submission of a biologics license application (BLA) for pipeline candidate, lecanemab (BAN2401).  The BLA is seeking approval for the candidate as a treatment for early AD under an accelerated pathway in the United States.

Let us take a look at some of the other companies which have promising candidates in the pipeline for AD:

3 Companies With Promising AD Candidates

Prothena Corporation PRTA has a portfolio of programs for the potential treatment of AD including PRX012, which targets Aβ (Amyloid beta) and a novel dual Aβ-Tau vaccine. PRX012 is a high-affinity monoclonal antibody targeting a key epitope within the N-terminus of Aβ. The company is developing PRX012 as a next-generation, high potency, anti-abeta antibody with best-in-class potential. Another promising candidate is PRX005. It is an investigational antibody that targets tau, a protein implicated in diseases including AD. Prothena is developing a dual vaccine, which concomitantly targets key epitopes within both the Aβ and tau proteins. The dual Aβ-Tau vaccine is being developed for the potential prevention and treatment of Alzheimer’s disease.    

Cassava Sciences, Inc. SAVA is evaluating its pipeline candidate simufilam, a proprietary, small molecule (oral) drug that restores the normal shape and function of altered filamin A (FLNA) protein in the brain, for AD. The company recently initiated an initial phase III efficacy study of simufilam. A second phase III efficacy study of simufilam in AD is expected to begin by the year-end. The late-stage efficacy studies of simufilam in AD are being conducted under Special Protocol Assessments (SPA) from the FDA.

Eli Lilly and Company LLY is evaluating donanemab, an investigational antibody therapy for AD. The company's phase II study, TRAILBLAZER-ALZ, investigated the efficacy and safety of donanemab in patients with early, symptomatic AD.  Lilly intends to submit a BLA for donanemab under the accelerated approval pathway later this year based on data from TRAILBLAZER-ALZ. The safety, tolerability and efficacy of donanemab are also being evaluated in the ongoing phase III study TRAILBLAZER-ALZ 2


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