Longeveron Announces First Patient Dosed in Phase 2 Clinical Trial for Aging-Related Frailty in Japan

Longeveron Inc. recently announced the first patient has been treated with Lomecel-B in its Phase 2 clinical trial in patients with Aging-Related Frailty in Japan. The trial aims to enroll 45 patients and its primary objective is to evaluate safety.

“We are excited to announce the dosing of the first patient in our Japanese Aging-Related Frailty trial,” said Wa’el Hashad, Longeveron’s Chief Executive Officer. “In 2022, Longeveron aligned with the Japan Pharmaceuticals and Medical Devices Agency (PMDA), on the Phase 2 trial design and we hope the data from this trial will provide support for a limited approval under Japan’s Act on the Safety of Regenerative Medicine (ASRM), which allows regenerative medicine products to be administered to patients by approved hospitals or clinics under the practice of medicine. This is the first use of our U.S.-manufactured product in Japan, and we look forward to advancing Lomecel-B as a treatment for Aging-Related Frailty in Japan.”

Hidenori Arai, MD, PhD, President of the National Center for Geriatrics and Gerontology, and principal investigator of the Phase 2 trial, added “I am pleased to see this clinical trial program advancing, especially given the large unmet need in Japan, where nearly 30% of the population is over the age of 65. I was encouraged by Longeveron’s previously announced Phase 2b Aging-Related Frailty study in the US, where subjects receiving a single infusion of Lomecel-B showed a statistically significant and clinically meaningful improvement in walking distance at 9 months post-infusion compared to placebo. I look forward to building on that data in the Japanese population.”

The Phase 2 clinical trial is a 3-arm, parallel design, randomized (1:1:1), placebo-controlled, double-blind single infusion study of two different dose levels of Lomecel-B. The trial is expected to enroll 45 patients and has a primary objective of evaluating safety of Lomecel-B as a treatment for Aging-Related Frailty. The trial is being conducted in partnership with the National Center for Geriatrics & Gerontology (NCGG;Nagoya) and Juntendo University Hospital (Tokyo).

Japan is considered to be a “super-aged” society with some 36.4 million individuals aged 65 or older in 2021, representing 29.1% of the population. The overall prevalence of aging-related frailty amongst this demographic is estimated to be 7.9%.

Aging-Related Frailty is an age-associated decline in reserve and function across multiple physiologic systems leading to the inability to cope with stressors. It is characterized by mobility impairment, weakness, fatigue, weight loss, slowness, and low activity and puts individuals at higher risk for poor clinical outcomes, such as infections, falls, fractures, hospitalization, or death.

Longeveron is a clinical-stage biotechnology company developing regenerative medicines to address unmet medical needs. The company’s lead investigational product is Lomecel-B, an allogeneic medicinal signaling cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Lomecel-B has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas. Longeveron is currently advancing Lomecel-B through clinical trials in three indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s Disease, and Aging-Related Frailty. For more information, visit www.longeveron.com.