By David Willey, Benzinga
Longeveron (NASDAQ: 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. (NASDAQ: BIIB) received accelerated approval from the FDA for its drug Aducanumab.
Acumen Pharmaceuticals (NASDAQ: ABOS) has completed a phase 1 trial for the drug ACU193, and Tiziana Life Sciences (NASDAQ: 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.
We are a clinical-stage biotechnology company developing cellular therapies for aging-related and life-threatening conditions.Our lead investigational product is Lomecel-B™, which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young healthy adult donors. We believe that by using the same cells that promote tissue repair, organ maintenance, and immune system function, we can develop safe and effective therapies for some of the most difficult diseases and conditions associated with aging.
Forward-Looking StatementsCertain statements in this press release that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management's current expectations, assumptions, and estimates of future operations, performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as "believe," "expects," "may," "looks to," "will," "should," "plan," "intend," "on condition," "target," "see," "potential," "estimates," "preliminary," or "anticipates" or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements in this release include, but are not limited to, statements regarding the offer and sale of securities, the terms of the offering, about the ability of Longeveron’s clinical trials to demonstrate safety and efficacy of the Company’s product candidates, and other positive results; the timing and focus of the Company’s ongoing and future preclinical studies and clinical trials and the reporting of data from those studies and trials; the size of the market opportunity for the Company’s product candidates, including its estimates of the number of patients who suffer from the diseases being targeted; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of the Company’s product candidates; the Company’s ability to obtain and maintain regulatory approval of its product candidates in the U.S., Japan and other jurisdictions; the Company’s plans relating to the further development of its product candidates, including additional disease states or indications it may pursue; the Company’s plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and its ability to avoid infringing the intellectual property rights of others; the need to hire additional personnel and the Company’s ability to attract and retain such personnel; the Company’s estimates regarding expenses, future revenue, capital requirements and needs for additional financing; the Company’s need to raise additional capital, and the difficulties it may face in obtaining access to capital, and the dilutive impact it may have on its investors; the Company’s financial performance, and the period over which it estimates its existing cash and cash equivalents will be sufficient to fund its future operating expenses and capital expenditure requirements. Additionally, Longeveron makes no assurance that any public offering of its securities as described herein will occur at all, or that any such transaction will occur on the timelines, in the manner or on the terms anticipated due to numerous factors. Further information relating to factors that may impact the Company's results and forward-looking statements are disclosed in the Company's filings with the Securities and Exchange Commission, including Longeveron’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 14, 2023. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
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