Alzheimer’s disease space suffered setbacks in June but drug companies remain hopeful, says GlobalData

With rapidly increasing worldwide prevalence, Alzheimer’s disease (AD) has been identified as a major global health threat by the international medical community. However, June was fairly disappointing for the AD space with several companies announcing negative results from clinical trials and other news for pipeline products, found GlobalData. Despite these setbacks, the leading data and analytics company notes that there is still promise for the future of AD treatment and much to be hopeful about in the near future.

Pippa Salter, Senior Neurology Analyst at GlobalData, comments: “AD is an indication for which the success rate of clinical trials is historically low, and much of the negative news announced last month highlights just how difficult it has been to develop novel drugs for the treatment of this disease. The failures touched a variety of different drug classes—from anti-amyloid agents to anti-psychosis agents.”

Roche announced that in a Phase II trial (NCT01998841), its anti-amyloid beta monoclonal antibody (mAb), crenezumab, failed to slow or prevent AD in cognitively unimpaired people who carry a specific genetic mutation causing early-onset AD.

Shortly after, Biogen terminated its observational study of Aduhelm (aducanumab) (NCT05097131), designed to collect real-world data on its use in clinical practice. This is just the latest setback for Aduhelm, which has been severely limited by restricted insurance coverage.

Salter continues: “This is a major blow for Biogen, as it is only through providing more data on Aduhelm that the restricted Medicare coverage policy may be revised. Now, Biogen is reliant on its Phase IV ENVISION trial (NCT05310071), which will take several years to provide results.

“For Roche, this follows previous Phase III clinical trial failures for crenezumab in patients with prodromal to mild sporadic AD, and it remains to be seen if Roche will continue to pursue this drug. For Biogen and Roche, it is expected that the anti-amyloid beta mAbs, lecanemab and gantenerumab, respectively, will be the focus for these companies going forward. Phase III trial readouts for these products, which do look promising, are expected in Q4 2022.”

Athira Pharmaceuticals also announced top-line results from its Phase II proof-of-concept study (NCT04491006) of its novel drug, fosgonimeton, for mild to moderate AD. Although the drug failed to meet the primary end point of the trial, Athira pointed to a pre-specified subgroup analysis of patients administered fosgonimeton monotherapy (versus in combination with acetylcholinesterase inhibitors) suggesting the drug could still be effective for AD.

Salter notes: “Athira has already initiated a Phase III clinical trial (NCT04488419) for fosgonimeton in mild to moderate AD however, it remains to be seen whether the benefits of fosgonimeton as a monotherapy will be demonstrated in this larger trial. If successful, GlobalData expects the drug to achieve US sales of $824 million by 2030.”

A further setback in the AD space came on June 17 when Acadia’s Nuplazid (pimavanserin) received a negative opinion from the FDA’s advisory panel for the treatment of AD psychosis.

Salter explains: “While the FDA does not have to follow the panel’s advice, it seems unlikely it will approve the drug given that, in April 2021, the FDA rejected Nuplazid for the treatment of dementia-related psychosis, which includes AD psychosis as a subgroup.”

Although prospects look bleak for Nuplazid, there has been a bit of good news for the treatment of AD-associated agitation. On June 27, Otsuka Pharmaceuticals and Lundbeck announced that in a Phase III study (NCT03548584), brexpiprazole significantly reduced agitation in patients with AD compared with placebo.

Salter adds: “Based on the positive outcome, Otsuka and Lundbeck plan to submit a supplemental New Drug Application to the FDA later in 2022. If successful, GlobalData expects brexpiprazole to achieve US sales of $415 million by 2030 in this indication.”

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