Lilly Reports Disappointing Data on Alzheimer's Candidate

Eli Lilly and Company LLY announced failure to meet endpoint in a phase II/III study on pipeline candidate, solanezumab, in patients with a rare inherited form of Alzheimer’s disease (“AD”).

The phase II/III study, DIAN-TU, is sponsored by the Washington University School of Medicine in St. Louis. The study tested two investigational therapies, solanezumab and Roche’s RHHBY gantenerumab compared to placebo to determine if either of these treatments could slow down the rate of cognitive decline and improve disease-related biomarkers in patients with dominantly inherited Alzheimer's disease (“DIAD”), also known as autosomal dominant Alzheimer's disease (“ADAD”). Moreover, gantenerumab also failed to meet the primary endpoint.

The primary outcome measure for the study — the DIAN Multivariate Cognitive Endpoint — is a novel outcome measure designed to assess cognitive performance in patients with DIAD.

Additional analyses are ongoing to understand the totality of the data. Results from the DIAN-TU-001 will be presented at the Advances in Alzheimer's and Parkinson's Therapies Focus Meeting scheduled later in April. The DIAN-TU study is being conducted as a platform study to evaluate potential disease-modifying therapies with different mechanisms to treat AD. The study was established in 2010 under a collaboration of Lilly, Roche and National Institutes of Health.

Following the dismal top-line data from the DIAN-TU study, Lilly stated that it currently has no plans to further develop solanezumab in DIAD patients. However, the company plans to continue developing solanezumab as a treatment for asymptomatic AD, presently being evaluated in a phase III study.

Lilly has faced several setbacks previously in relation to candidate being developed for treating AD, including solanezumab. In 2016, the company failed to meet primary endpoint of a phase III study – EXPEDITION3 – evaluating solanezumab in people with mild dementia due to AD.  In 2018, the company discontinued a phase III program evaluating another AD candidate, lanabecestat.

Shares of Lilly have rallied 21.8% in the past year compared with the industry’s increase of 12.5%.

Alzheimer’s, a fatal condition that causes progressive decline in memory, has always been a highly challenging area and not much progress has been made despite significant investments (both funds and resources). Several companies, including Lilly and Roche, have failed to develop safe and effective treatment options for this deadly brain disease.

Biogen BIIB, one of the companies with several AD candidates in its pipeline, has suffered multiple setbacks in the past couple of years and discontinued several late-stage studies. However, the company plans a regulatory filing for AD candidate, aducanumab, soon. Apart from Biogen, Novartis NVS and Amgen also discontinued two pivotal phase II/III studies evaluating their BACE1 inhibitor, CNP520, in AD patients.

Despite the setbacks, companies continue to invest heavily in developing AD treatments, given the high commercial potential in this market.

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