FDA grants fast-track designation to cellular therapy for mild Alzheimer’s

The FDA has granted fast-track designation to a proprietary, scalable, allogeneic, investigational cellular therapy in development to address symptoms of mild Alzheimer’s disease, according to the manufacturer.

Lomecel-B (Longeveron Inc.) was investigated in a just-completed phase 2a clinical trial for Alzheimer’s disease (AD) and a phase 2b study for aging-related frailty. It is also being evaluated in an ongoing phase 2b trial for hypoplastic left heart syndrome (HLHS), Longeveron Inc. said in a release.

The FDA’s decision was based upon positive topline data reported from the phase 2a CLEAR MIND randomized clinical trial, which compared three different dosing regimens of Lomecel-B vs. placebo in 48 older adults aged 60 to 85 years with mild AD.

Lomecel-B had previously received Regenerative Medicine Advanced Therapy designation by the FDA for its AD indication, while the novel therapeutic’s HLHS program previously received orphan drug, fast-track and rare pediatric disease designations.

“Fast-track designation is another important milestone for Longeveron and Lomecel-B, which, along with the recent granting of Regenerative Medicine Advanced Therapy designation, recognizes the critical need to quickly advance novel, safe and effective investigational treatments for Alzheimer’s disease, which has a devastating impact on patients and their families,” Longeveron CEO Wa’el Hashad said in the release.

Reference:

Lomecel-B Effects on Alzheimer's Disease (CLEARMIND). https://clinicaltrials.gov/study/NCT05233774. Accessed July 17, 2024.