Longeveron Inc (LGVN): Announces Commencement of Phase 2a Trial Dedicated to Cellular Therapy Lomecel-B Treating Alzheimer’s Disease

Longeveron Inc (LGVN) is a clinical stage biotech company that focuses on developing cellular-based therapies dedicated towards treating aging related and life-threatening conditions. The companies lead treatment option is Lomecel-B, which originates from expanded medicinal signalling cells (MSC’s) that are sourced from bone marrow in young healthy adults. Through leveraging the same cells that promote natural tissue repair in healthy bodies the company hopes to develop safe and effective treatment options for diseases and conditions associated with aging. So far, Longeveron is pursuing efficacy studies to treat multiple different illnesses including aging frailty, Alzheimer’s disease, metabolic syndrome, acute respiratory distress syndrome (ARDS) and hypoplastic left heart syndrome (HLHS).

Longeveron recently announced it will begin the initiation period of its Phase 2a clinical trial which will be aimed at evaluating Lomecel-B as a treatment option for Alzheimer’s disease (AD). From this, the company will now begin patient screening, with the first patient already consenting to participate.

Expanding on Positive Phase 1 Data

This Phase 2a trial builds off the success of Longeveron’s preliminary Phase 1 data, which was designed for safety and exploratory efficacy. This first study consisted of 33 patients between the ages of 50-80 who were all clinically diagnosed with mild AD. The test subjects were broken into three groups who received either a placebo, 20M or 100M dose of Lomecel-B. Follow ups were held in weeks 2,4,13,26,39, and 52, where subjects were assessed for safety, neurocognitive and neuropsychiatric improvements, various biomarkers, quality of life, and activities of daily living.

Looking at the charts above the results of the study indicated that those who received a low dose of Lomecel-B declined more slowly than the placebo group. Lomecel-B showed positive changes in pro-vascular biomarkers, as well as showing positive changes in inflammatory-associated cytokines. And most importantly, the primary end point of the study was met showing doses were well tolerated with no Amyloid Related Imaging Abnormalities (ARIA) identified.

Further Solidifying Lomecel-B’s Safety & Efficacy in Phase 2a Trial

The companies new Phase 2a trial will be a double blind, randomized, placebo-controlled study with primary end points being to investigate safety and tolerability within patients, plus secondary end points including cognitive function and biomarkers. All subjects will be clinically diagnosed with AD and those not in the placebo group will receive single or multiple infusions of Lomecel-B.

Longeveron plans to include 4 different treatment arms of 12 patients each, bringing the total ideal enrollment to 48 patients. As well, this study will also measure brain anatomy using MRI technology and include detailed assessments of the inflammatory and vascular systems thought to contribute to the worsening of AD. Led by Mark L. Brody, MD, of Brain Matters Research, Delray Beach, Florida this trial will be conducted at a minimum of 6 different centers.

Geoff Green, CEO of Longeveron discussed this new study saying “This is an important next step in the progress of our Alzheimer’s disease clinical program. We are pleased to have initiated this Phase 2a trial, as this study is intended to build upon the Phase 1 results and marks an important milestone in our efforts to explore the therapeutic potential of Lomecel-B in AD.”

A Brief Look Ahead

With this announcement Longeveron further solidifies their Lomecel-B treatment option as a promising product. The company is conducting multiple different Phase 1 and Phase 2 studies, which so far have showed statistically meaningful positive results in terms of both safety and efficacy. Additionally, as the world enters the new year Longeveron plans to initiate a Phase 2 study based on treating aging frailty in Japan, as well as receive top line data from their Aging Frailty Influenza Vaccine Phase 1/2 “HERA” Trial.

Not only is Longeveron executing on delivering encouraging trial results, but they are also building out the necessary back-end operations and capacity to produce Lomecel-B efficiently. From their cGMP certified facility located in Miami FL, Longeveron has built a manufacturing process that allows for the treatment option to be produced at mass scale while also being an “off the shelf” cellular therapy for patients. As well, Lomecel-B is cryogenically stored and can maintain a long shelf life, allowing for efficient and low-cost supply distribution. 

According to Bright focus foundation, at least 50 million people internationally suffer from AD, and estimates show that number could reach 150 million by 2050. What’s more, deaths attributed to AD rose 139% between 2000 and 2016, meaning this disease is becoming more lethal with time. These stats show Longeveron’s Lomecel-B treatment candidate has the opportunity to serve a huge addressable market which is expanding quickly due to an aging global population.  

AD is only one of many illnesses the company is proving they can treat effectively, and with a strong pipeline of further studies planned to be conducted into 2022 Longeveron has a bright future ahead. Also, with their recent IPO in February of 2021 the company has improved their cash position to approximately $19 million, which should allow them to cover expenses and capital requirements for the entirety of 2022.  

Key Takeaway

Longeveron will look to continue the momentum and positive results they saw in 2021 into the new year, and with very strong preliminary data coming from multiple Phase 1 & 2 studies there is no reason to think the company won’t deliver. AD has a large and diverse global market, and this new Phase 2a trial will look to further prove the safety and efficacy of Lomecel-B in treating this life-threatening affliction. With a robust portfolio of future trials in place, a strong backing of preliminary data, and a manufacturing process that allows for mass commercialization Longeveron certainly has the markings of a biotech powerhouse in the making. The company is well on track to make 2022 their most successful year yet, and investors should keep Longeveron at the top of their 2022 watchlists.