Longeveron(US:LGVN)2023-11-10 13:17Lomecel-B™ Clinical Programs - Lomecel-B™ is in Phase 2 trials for Hypoplastic Left Heart Syndrome (HLHS), Aging-Related Frailty, and Alzheimer's Disease [14, 20] - A Phase 2 trial in Japan for Aging-Related Frailty is ongoing [12, 24] - Enrollment is completed in a Phase 2a trial for Alzheimer's Disease, with topline data anticipated by October 2023 [20, 90] - ELPIS II, an ongoing Phase 2 trial of Lomecel-B™ in HLHS, aims to improve Right Ventricular Ejection Fraction (RVEF) [71, 72] Aging-Related Frailty - A Phase 2b study (N=143) explored the dose response of Lomecel-B™ in aging-related frailty [59] - The study showed a statistically significant dose response at 180 days, with p<0.05 and p<0.01 versus placebo [62] - The study included treatment groups with 25 million, 50 million, 100 million, and 200 million Lomecel-B™ cells [61, 74] Alzheimer's Disease - A Phase 1b randomized, placebo-controlled trial (N=33) of Lomecel-B™ in Alzheimer's Disease showed a statistically significant improvement in cognition as measured by MMSE scores in the low-dose (20 million cells) group compared to placebo [85, 98] - The Phase 1b trial included patients with MMSE scores of 18-24 [86] - The Phase 2a Alzheimer's Disease study design is ongoing with 48 patients [89, 123] Hypoplastic Left Heart Syndrome (HLHS) - In SVR historically matched controls, 5-year mortality was ~20% [49] - Positive ELPIS 1 (Phase 1b) Trial Results (N=10) showed no transplants required in the 10 patients during the one year of the study duration [33]