The long and difficult road to conquer dementia … Failed to develop Alzheimer’s treatment again

[헬스코리아뉴스 / 이충만] In 1907, more than 100 years have passed since Alzheimer’s was first reported, but there is still no cure for it. Alzheimer’s is the most common degenerative brain disease that causes dementia, and pharmaceutical and bio companies around the world are making ambitious challenges to conquer this disease, but they have failed every time. For this reason, patients are still relying on symptomatic therapy to relieve symptoms and delay progression, rather than fundamental treatment.

The Alzheimer’s treatment that has recently received the greatest attention is ‘Aduhelm’ (ingredient name: aducanumab), which was approved by the US Food and Drug Administration (FDA) on June 7 (local time) last year. ‘Aduhelm’, jointly developed by Biogen of the US and Esai of Japan, is the first new Alzheimer’s treatment drug in about 20 years after ‘Namenda’ of Allergan, Ireland, and ingredient name: memantine. It also cast its vote as the first fundamental treatment.

However, at the time, ‘Aduhelm’ was heavily criticized due to controversy over its medicinal efficacy. Despite the unanimous opposition of the advisory committee to the approval, when the FDA pushed for the approval, the advisory members of the advisory committee faced harsh criticism, including resignation one after another. In the end, the European Medicines Agency (EMA) rejected the approval of ‘Eduhelm’ in December 2021, and Eisai gave up the profit-sharing right for ‘Aduhelm’ in March of this year.

Alzheimer’s treatment suffers from difficulties from the beginning of the development process, and even the approved treatment drugs continue to be controversial. It is analyzed that this is due to the lack of a systematic and fundamental understanding of the human brain. It is pointed out that the approach to treating Alzheimer’s disease according to the complexity of the brain is also limited by the current study.

In the midst of this, ‘crenezumab’, an amyloid-targeted Alzheimer’s treatment candidate being developed by Roche, Switzerland, failed to prove efficacy in a phase 3 clinical trial, leaving a record in the history of treatment failure once again.

Roche’s ‘crenezumab’ fails in Alzheimer’s patients in phase 3 … All studies are suspended

Genentech, a subsidiary of Roche, announced on the 16th (local time) that it did not meet the endpoints in a phase 3 clinical trial that evaluated ‘crenezumab’ in ‘autosomal dominant Alzheimer’s’ patients.

This study was conducted on 252 patients with autosomal dominant Alzheimer’s disease, and about 60% of them carried the PSEN1 E280A mutant gene, which is known to cause Alzheimer’s-related cognitive impairment before or after the age of 44. Patients were randomized to receive crenezumab and placebo for up to 8 years, and the dose of crenezumab was also increased during the trial period as information on treatment approaches for Alzheimer’s developed.

Genentech explained that ‘crenezumab’ had a good safety profile, and small numerical improvements were found through exploratory factor analysis. However, none of the primary and secondary endpoints demonstrated statistically significant improvement compared to placebo.

Levi Garraway, Roche Chief Medical Officer, said on the same day, “This is a disappointing result, but we would like to thank patients and their families who have made a significant contribution to the understanding of Alzheimer’s and the development of new treatments.” How to Diagnose and Treat Alzheimer’s We will continue to work to explore the

Crenezumab is a monoclonal antibody designed to neutralize the neurotoxic low molecular weight polymer of beta-amyloid protein. The substance was discovered by AC Immune SA in Switzerland. In 2006, Genentech entered into an exclusive license agreement with AC Immune to pay AC Immune up to $300 million in incentives.

In accordance with the recommendations of the Independent Data Monitoring Committee (IDMC) in 2019, Roche previously discontinued a phase 3 study that evaluated ‘crenezumab’ in patients with mild ‘sporadic Alzheimer’s’ in the prognostic stage. As a result, all clinical studies of ‘crenezumab’ for Alzheimer’s disease ended in failure.

However, Roche is conducting a phase 3 clinical trial of ‘gantenerumab’, another amyloid-targeted Alzheimer’s treatment candidate. The results of the study are expected to be published in the fourth quarter of this year.

On the other hand, according to IMARC research data, the global Alzheimer’s disease treatment market size was calculated to be 6.34 billion dollars in 2020 (about 8,169 billion won), and is expected to gradually expand with a CAGR of 6.5% from 2021 to 2026. prospect. [아래 관련기사 참조]

Although it received attention as a fundamental treatment, it was eventually evaluated that it was a failed new drug. According to Biogen, there have been many cases of refusal to use in clinical settings due to controversy over drug efficacy, which has caused a setback in actual supply.

As a result, Biogen announced in May that it would withdraw its European license application for ‘Eduhelm’, and that it would reduce and abolish the ‘Aduhelm’ business unit.

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