- Longeveron, a clinical-stage biotechnology company developing cellular therapies for aging-related and life-threatening conditions, reported positive top-line results from its CLEAR MIND Phase 2a human clinical trial
- The study, which explored Lomecel-B(TM)’s effects on mild Alzheimer’s disease, met the primary endpoint of safety on statistical and medical assessment
Longeveron (NASDAQ: LGVN), a clinical-stage biotechnology company developing cellular therapies for aging-related and life-threatening conditions, just announced positive top-line results from its CLEAR MIND Phase 2a clinical trial for treating mild Alzheimer’s disease. Most notably, the primary endpoint of safety was met based on statistical and medical assessment, with only one Serious Adverse Event (“SAE”) reported on each Lomecel-B(TM) group in what Dr. Jeffrey Cummings, MD, Vice Chair of Research, UNLV Department of Brain Health, described as “Encouraging results” (https://ibn.fm/BNOjU).
This study was designed to explore Lomecel-B(TM)’s effects on mild Alzheimer’s disease. Dubbed the CLEAR MIND trial, this randomized, double-blinded, placebo-controlled Phase 2a trial included 50 patients aged between 60 and 85 years diagnosed with mild Alzheimer’s disease. The study was conducted at ten centers in the United States, testing three different dosing regimens of Lomecel-BT(TM) vs. placebo, with patients randomized in a 1:1:1:1 ratio.
Wa’el Hashad, Longeveron’s CEO, was pleased with the results, noting how they validated the safety and therapeutic potential of Lomecel-B(TM) for treating Alzheimer’s disease.
“We believe these results provide important validation of both the safety and therapeutic potential of Lomecel-B(TM) in the treatment of Alzheimer’s disease and provide a robust foundation for additional clinical trials in this and other indications,” he noted.
Lomecel-B(TM) is Longeveron’s lead investigational product and has shown potential in anti-inflammatory and pro-vascular regenerative responses. This potential has prompted Longeveron to explore its application in aging-related chronic diseases and other life-threatening conditions under the U.S. FDA-approved Investigational New Drug applications. So far, the product has demonstrated multiple potential mechanisms of action that cover pro-regenerative, pro-vascular, anti-inflammatory, and tissue repair and healing effects, ultimately expanding its potential application across multiple disease areas.
With its success in the CLEAR MIND Phase 2a clinical trial, Longeveron hopes to continue the momentum, including announcing plans to announce additional biomarker data from the trial in November.
“We look forward to announcing additional biomarker data from this trial, anticipated in November 2024, which may further characterize the clinical effects of Lomecel-B(TM) in this study population,” noted Mr. Hashad.
In addition, Mr. Hashad shared the company’s plans for the Phase 2b ELPIS II clinical trial in Hypoplastic Left Heart Syndrome (“HLHS”), which is anticipated to be completed in 2024, and the company’s Aging-related Frailty Phase 2 program, which is currently ongoing in Japan. Combined, all these studies reflect Longeveron’s commitment to try to create shareholder value and establish its position as a leader in its segment.
Certain statements in this article 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 ability to continue as a going concern, 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 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 Securities and Exchange Commission on March 14, 2023 and its Quarterly Report on Form 10-Q for the second quarter of 2023 filed with the SEC on August 11, 2023. The forward-looking statements contained in this article are made as of the date of this article, 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.
For more information, visit the company’s website at www.Longeveron.com.
NOTE TO INVESTORS: The latest news and updates relating to LGVN are available in the company’s newsroom at http://ibn.fm/LGVN
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