STOCK TITAN

Longeveron Announces Abstract Highlighting Data from Phase 1 Alzheimer’s Disease Trial Accepted for Developing Topics Presentation at the 2021 Annual Alzheimer's Association International Conference

Rhea-AI Impact
(Moderate)
Rhea-AI Sentiment
(Neutral)
Rhea-AI Summary

Longeveron Inc. (NASDAQ: LGVN) announced the acceptance of an abstract for a poster presentation at the 2021 Annual Alzheimer's Association International Conference. This presentation highlights the results of their Phase 1 trial on Lomecel-B infusion in patients with mild Alzheimer’s disease. The trial met its primary endpoint of safety and feasibility, showing no Alzheimer’s Related Imaging Abnormalities (ARIA). Additionally, low-dose Lomecel-B demonstrated a reduction in cognitive decline compared to placebo, measured by the Mini Mental State Exam (MMSE). A Phase 2 trial is anticipated in the second half of 2021.

Positive
  • Trial demonstrated safety and feasibility with no ARIA.
  • Low-dose Lomecel-B infusion slowed cognitive decline compared to placebo.
  • Next Phase 2 trial scheduled for second half of 2021.
Negative
  • None.

Abstract presentation highlights safety and potential efficacy of Lomecel-B infusion in patients with mild Alzheimer’s Disease

MIAMI, June 24, 2021 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing cellular therapies for aging-related and chronic disease, announced today that an abstract summarizing the results of its Phase 1 trial of Lomecel-B infusion for patients with mild Alzheimer’s disease has been accepted for a Developing Topics poster presentation at the 2021 Annual Alzheimer's Association International Conference, being held July 26-30, 2021 in Denver, CO and online.

The abstract is titled “Safety and Efficacy of Lomecel-B in Patients with Mild Alzheimer’s Disease: Results of a Double-Blinded, Randomized, Placebo-Controlled, Phase 1 Clinical Trial.” This 33 subject study was supported by two competitive Part the Cloud Challenge on Neuroinflammation grants from the Alzheimer’s Association. The previously announced results can be found on the “News and Events” page in the Investors section of Longeveron’s website at investors.longeveron.com.

“We are extremely pleased that the Alzheimer’s Association has recognized our trial and data by giving us this opportunity to present the findings in poster presentation form at the prestigious AAIC,” said Dan Gincel, Ph.D., Senior Vice President of Strategic Collaborations & Scientific Affairs at Longeveron. “The trial met its primary endpoint of demonstrating safety and feasibility, and importantly, no Alzheimer’s Related Imaging Abnormalities (ARIA), after infusion with Lomecel-B. Furthermore, we were thrilled to observe that treatment with low-dose Lomecel-B slowed cognitive decline compared to the placebo group as measured by the Mini Mental State Exam (MMSE) score. As a result, we look forward to advancing Lomecel-B into a Phase 2 clinical trial in the second half of 2021.”

Information about the Annual Alzheimer's Association International Conference can be found at www.alz.org/aaic/overview.asp.

About Longeveron Inc.

Longeveron is a clinical stage biotechnology company developing cellular therapies for specific aging-related and life-threatening conditions. The Company’s lead investigational product is the LOMECEL-B™ cell-based therapy product (“Lomecel-B”), which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young, healthy adult donors. Longeveron believes that by using the same cells that promote tissue repair, organ maintenance, and immune system function, it can develop safe and effective therapies for some of the most difficult disorders associated with the aging process and other medical disorders. Longeveron is currently sponsoring Phase 1 and 2 clinical trials in the following indications: Aging Frailty, Alzheimer’s disease, and hypoplastic left heart syndrome (HLHS). The Company’s mission is to advance Lomecel-B and other cell-based product candidates into pivotal Phase 3 trials, with the goal of achieving regulatory approvals, subsequent commercialization and broad use by the healthcare community. Additional information about the Company is available at www.longeveron.com.

Forward-Looking Statements

Certain statements in this press release that are not historical facts are forward-looking statements that reflect management's current expectations, assumptions, and estimates of future 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. Moreover, forward-looking statements in this release include, but are not limited to, statements about the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; the timing and focus of our ongoing and future preclinical studies and clinical trials; the size of the market opportunity for our product candidates, the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our ability to obtain and maintain regulatory approval of our product candidates, our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others. 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 SEC. 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.

Investor Contact:

Brendan Payne
Stern Investor Relations, Inc.
Office Direct: 212-698-8695 |Office Main: 212-362-1200
brendan.payne@sternir.com | www.sternir.com

Source: Longeveron Inc
Source: LGVN


FAQ

What were the results of the LGVN Phase 1 clinical trial for Lomecel-B?

The Phase 1 trial showed safety and feasibility of Lomecel-B with no ARIA and a reduction in cognitive decline compared to placebo.

What is the purpose of the Lomecel-B trial in Alzheimer's patients?

The trial aims to evaluate the safety and efficacy of Lomecel-B infusion in patients with mild Alzheimer’s disease.

When is the next clinical trial for Lomecel-B scheduled?

A Phase 2 clinical trial for Lomecel-B is planned for the second half of 2021.

What event will feature the results of the Lomecel-B trial?

The results will be presented at the 2021 Annual Alzheimer's Association International Conference from July 26-30, 2021.

What is the significance of the Mini Mental State Exam (MMSE) in the LGVN trial?

The MMSE was used to measure cognitive decline in patients treated with Lomecel-B compared to the placebo group.

Longeveron Inc.

NASDAQ:LGVN

LGVN Rankings

LGVN Latest News

LGVN Stock Data

27.82M
11.99M
10.7%
3.34%
8.89%
Biotechnology
Pharmaceutical Preparations
Link
United States of America
MIAMI