Longeveron Announces Positive Top-Line Results for Lomecel-B™ in its CLEAR MIND Phase 2a Clinical Trial in the Treatment of Mild Alzheimer’s Disease
Company to Hold Conference Call & Webcast Today, October 5 at 8:00am ET
Primary Endpoint of Safety Met Across all Study Groups
Statistical Significance Met for Secondary Endpoint Composite Alzheimer’s Disease Score (CADS) for Lomecel-B™ Low-Dose and for the Pooled Lomecel-B™ Treatment Group Relative to Placebo
Other Doses Demonstrated Numerical Slowing/Prevention of Disease Worsening Relative to Placebo
Additional Biomarker Data Expected to be Announced in the Coming Weeks
MIAMI, Oct. 05, 2023 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions such as hypoplastic left heart syndrome (HLHS), Alzheimer’s disease and Aging-related Frailty, today announced positive top-line results from its Phase 2a trial of its investigational product Lomecel-B™ for the treatment of mild Alzheimer’s disease. The Company is hosting a conference call and webcast today at 8:00 AM ET to discuss the results.
“We believe these results provide important validation of both the safety and therapeutic potential of Lomecel-B™ in the treatment of Alzheimer’s disease and provide a robust foundation for additional clinical trials in this and other indications,” said Wa’el Hashad, Chief Executive Officer of Longeveron. “We look forward to announcing additional biomarker data from this trial, anticipated to be later this month, which may further characterize the clinical effects of Lomecel-B™ in this study population. With our Phase 2 ELPIS II trial in HLHS moving toward anticipated completion in 2024, and our Phase 2 program in Aging-related Frailty progressing in Japan as well, we look forward to meaningful milestones in the near term and to fully realizing the therapeutic potential of Lomecel-B™.”
“These study results with Lomecel-B™ are encouraging,” added Dr. Jeffrey Cummings, MD, Vice Chair of Research, UNLV Department of Brain Health. “The study met its primary safety endpoint and is supported by lack of deterioration in cognitive or atrophy signals. The efficacy observations are encouraging, and these results should be used as a foundation for further studies.”
“We are encouraged by these results, which appear to be further supported by their consistency with the findings from Longeveron’s earlier Phase I study on Alzheimer’s disease,” concluded Dr. Nataliya Agafonova, Chief Medical Officer of Longeveron.”
An estimated 6.7 million Americans are living with Alzheimer’s disease. Of the total U.S. population, about 1 in 9 people aged 65 and older has Alzheimer’s disease. The percentage of people with Alzheimer’s disease increases with age. Despite progress for new anti-amyloid treatment, there remains a high unmet medical need.
Conference Call and Webcast Details
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Conference ID# 13741797
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Results:
The primary endpoint of safety was met based on statistical and medical assessment. There was one Serious Adverse Event (SAE) reported on each Lomecel-B™ treatment group and none on placebo. Each SAE was reviewed and assessed by the Data and Safety Monitoring Board (DSMB) with no safety issues raised.
The study safety data were consistent with an established safety profile with no incidence of hypersensitivity, no cases of Alzheimer Related Imagine Abnormalities (ARIA), no clinically asymptomatic microhemorrhages as revealed by Magnetic Resonance Imaging (MRI), and no notable changes in laboratory evaluations and electrocardiogram (EKG).
The secondary endpoint of change from baseline to week 39 in CADS, demonstrated positive results, at the prespecified statistical level of p<0.1, 2-tailed:
Statistically significant improvement at Week 39 in CADS was observed for the Lomecel-B™ 25 x 106 cells (25M) x 1 dose (p=0.091) versus placebo and for the pooled Lomecel-B™ Groups (25M x 1 dose, 25M x 4 doses, 100 x 106 cells (100M) x 4 doses) (p=0.099).
In terms of the specific components of the CADS score, evaluated at p<0.05, 2-tailed:
Lomecel-B™ (25M x 1 dose) demonstrated statistically significant slowing of disease progression in left hippocampal volume (p=0.015) relative to placebo
ADCS-ADL and left hippocampal volume at Week 39 were statistically significant for the pooled Lomecel-B™ treatment groups (25M x 1 dose, 25M x 4 doses, 100M x 4 doses) relative to placebo (p=0.047) and (p=0.038), respectively
Other doses demonstrated numerical slowing and prevention of disease worsening relative to placebo in CADS, ADAS-cog13, CDR-SB, ADCS-ADL and left hippocampal volume at Week 39
About The CLEAR MIND Study
The trial was designed to study Lomecel-B™ Effects on mild Alzheimer’s disease: A Randomized, Double-Blinded, Placebo-Controlled Phase 2 Trial (NCT05233774), named the CLEAR MIND trial. The trial included a total of 50 patients who were 60-85 years old and had a diagnosis of mild Alzheimer’s disease in accordance with National Institutes of Health – Alzheimer’s Association (NIA-AA) criteria, Mini-Mental State Examination (MMSE) score of 18-24, and a brain MRI and positron emission tomography (PET) scan consistent with Alzheimer’s disease. The trial was designed to test three different dosing regimens of Lomecel-B™ vs. placebo, and patients were randomized in a 1:1:1:1 ratio. The following doses were studied: Lomecel-B™ at a dose of 25 x 106 cells (25M) on Day 0, followed by placebo infusions at Week 4, Week 8 and Week 12; Lomecel-B™ at a dose of 25M administered on Day 0, Week 4, Week 8, and Week 12 for a total of 4 doses; and at a dose of 100 x 106 cells (100M) administered on Day 0, Week 4, Week 8, and Week 12, for a total of 4 doses.
The trial randomized 50 patients (49 were treated) and was conducted at 10 centers in the US. The primary endpoint of the trial is safety as measured by the occurrence of serious adverse events (SAEs) within the first 30 days after each administration of Lomecel-B™.
In consideration of the study sample size (N=49 patients), the study employed a novel global statistical test approach known as a Composite Alzheimer’s Disease Score (CADS, which is accepted and increasingly used by the scientific community for AD clinical trials). The CA
