Upcoming Phase 2 Data Expected For Longeveron's (NASDAQ: LGVN) Drug For the $4+ Billion Alzheimer's Sector – What To Look For

Longeveron LGVN, a clinical-stage biopharma developing potential treatments for age-related and life-threatening diseases, is expecting data from its phase 2a trial for its Lomecel-B™ cellular drug in the next 3 to 4 months.

Longeveron’s primary drug candidate, a cell-based medicine, is being tested for several indications, including Aging-related Frailty, a rare pediatric disease called hypoplastic left heart syndrome (HLHS), and Alzheimer’s disease (AD). It is running phase 2 trials for each of these conditions and expects to announce top-line results for the AD trial soon.

A previous clinical study indicated that Lomecel-B’s™ mechanisms of action (MoA) had the potential to affect  multiple AD markers simultaneously, such as reducing neuroinflammation, improving neural blood vessels, and decreasing the brain damage that comes from AD. According to Longeveron, other potential therapies being tested mainly target amyloid plaques or neurofibrillary tangles. Longeveron uses medicinal signaling cells (MSCs) that may cross the blood-brain barrier (based on results from animal studies) and are primarily aimed at downregulating inflammation, which is a pathway associated with AD’s neurodegeneration, including memory loss.  

Longeveron completed a randomized, placebo-controlled phase 1 trial that tested for safety as a primary objective, as well as potential efficacy. The trial saw no serious adverse events and indicated a statistically significant improvement in cognition in the patients. Importantly, the trial showed that Lomecel-B™ did not appear to cause ARIA (Alzheimer’s Related Imaging Abnormality), a serious potential side effect of some AD treatments.

These results led to Longeveron initiating a phase 2 trial late in 2022, a 41-week trial on 48 patients with mild AD. The primary objective for the trial is safety, though the Company is exploring signals for multiple secondary endpoints, including cognitive measures, the AD assessment scale for cognitive function (ADAS-Cog), and inflammatory biomarkers. In addition, the trial is also designed to test whether repeat dosing of Lomecel-B™ may produce greater drug efficacy.   The Company anticipates that if the trial is successful and shows efficacy, there is the potential for Lomecel-B™ to be developed as a disease-modifying treatment for AD.

Longeveron’s Position In An Active Market

By developing Lomecel-B™ as a potential treatment for AD, Longeveron is positioning itself for potential success in a growing sector. With over 6 million Americans suffering from AD in 2021, there is a drive in the pharmaceutical sector to develop a range of treatments for the disease. Multiple companies are currently attempting to develop treatments, while others have received accelerated approval for their drugs from the FDA. The global market for Alzheimer’s Disease therapies was worth $4.05 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of about 20% from 2023 to 2030.

In 2021, Biogen Inc. BIIB received accelerated approval from the FDA for its drug Aducanumab.

Acumen Pharmaceuticals ABOS has completed a phase 1 trial for the drug ACU193, and Tiziana Life Sciences TLSA has filed an investigational new drug (IND) application for its drug, Foralumab, for its AD indications.

Follow developments from Longeveron’s cell-based therapies on its website.

Featured photo by Matteo Vistocco on Unsplash.

This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice.