Lexeo Therapeutics Announces Investor Webcast to Report Interim Phase 1/2 Clinical Data of LX2006 for the Treatment of Friedreich Ataxia Cardiomyopathy on Monday, July 15, 2024

Rhea-AI Summary

Lexeo Therapeutics announced an investor webcast on July 15, 2024, to present interim Phase 1/2 clinical data for LX2006, a gene therapy targeting Friedreich ataxia cardiomyopathy. The webcast will cover the natural history of the disease, clinically meaningful endpoints, interim data from the ongoing SUNRISE-FA trial, and next steps for the program. The SUNRISE-FA trial is a 52-week, dose-ascending, open-label study evaluating LX2006's safety and efficacy. Additionally, Weill Cornell Medicine is conducting a similar Phase 1A trial. Lexeo licensed key intellectual property from Weill Cornell in April 2024.

Positive

• Interim data presentation scheduled, indicating progress in clinical development.
• Ongoing SUNRISE-FA Phase 1/2 trial evaluating safety and efficacy of LX2006.
• Weill Cornell Medicine conducting a supportive Phase 1A trial with positive partnerships.
• Licensing of intellectual property from Weill Cornell strengthens Lexeo's position.

Negative

• No final data available yet, indicating ongoing risk and uncertainty.
• Potential for clinical trial delays or adverse findings not yet disclosed.

NEW YORK, July 11, 2024 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering treatments for genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease, today announced that the company will conduct an investor webcast on Monday, July 15, 2024, at 8:00 AM ET to provide an interim clinical data update on LX2006, an AAVrh10.hFXN gene therapy for the treatment of Friedreich ataxia (FA) cardiomyopathy. The presentation will include an overview of the natural history of FA cardiomyopathy and summary of clinically meaningful endpoints, interim data from Lexeo’s ongoing SUNRISE-FA Phase 1/2 clinical trial (NCT05445323) and the ongoing Weill Cornell Medicine investigator-initiated trial (NCT05302271), as well as an overview of program next steps.

To register for and access the conference call and webcast presentation, please visit https://ir.lexeotx.com/news-events/events or you can register directly at this link. The on-demand webcast presentation may be accessed under the News & Events tab in the Investors section of the Company’s website. A replay of the webcast will be available on the website following the presentation.

SUNRISE-FA is a multicenter, 52-week, dose-ascending, open-label trial evaluating the safety and preliminary efficacy of LX2006 in patients who have FA cardiomyopathy. LX2006 is administered as a one-time intravenous infusion to patients in at least two ascending-dose cohorts with the potential to escalate to a third cohort at a dose of 1.2x10¹² vg/kg. Investigators at Weill Cornell Medicine are conducting a Phase 1A study of AAVrh.10hFXN, known as LX2006 at Lexeo, in a single-site, 52-week, dose-ascending, open-label trial evaluating the safety and preliminary efficacy of AAVrh.10hFXN in patients who have FA cardiomyopathy. In the Weill Cornell trial, AAVrh.10hFXN is administered as a one-time intravenous infusion to patients in two ascending-dose cohorts with five participants per cohort. In April 2024, Lexeo licensed certain intellectual property rights including rights to current and future data generated from the ongoing Phase 1A trial of AAVrh.10hFXN conducted by Weill Cornell Medicine.

About Lexeo Therapeutics
Lexeo Therapeutics is a New York City-based, clinical stage genetic medicine company dedicated to transforming healthcare by applying pioneering science to fundamentally change how genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease are treated. Using a stepwise development approach, Lexeo is leveraging early proof-of-concept functional and biomarker data to advance a pipeline of cardiovascular and APOE4-associated Alzheimer’s disease programs.

Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, statements related to the timing and content of the LX2006 clinical data update press release, investor webcast and investor presentations. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Lexeo believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements. These forward-looking statements are based upon current information available to the company as well as certain estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Lexeo’s filings with the U.S. Securities and Exchange Commission (SEC)), many of which are beyond the company’s control and subject to change. Actual results could be materially different from those indicated by such forward looking statements as a result of many factors, including but not limited to: risks and uncertainties related to global macroeconomic conditions and related volatility; expectations regarding the initiation, progress, and expected results of Lexeo’s preclinical studies, clinical trials and research and development programs; the unpredictable relationship between preclinical study results and clinical study results; delays in submission of regulatory filings or failure to receive regulatory approval; liquidity and capital resources; and other risks and uncertainties identified in Lexeo’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2024, filed with the SEC on May 9, 2024, and subsequent future filings Lexeo may make with the SEC. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Lexeo claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Lexeo expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

Media Response:
Janine Bogris
(201) 245-6838
janine.bogris@inizioevoke.com

Investor Response:
Stephen Jasper
(858) 525-2047
stephen@gilmartinir.com

FAQ

What is the purpose of Lexeo Therapeutics' webcast on July 15, 2024?

The webcast aims to update investors on interim Phase 1/2 clinical data for LX2006, a gene therapy for Friedreich ataxia cardiomyopathy.

What is LX2006?

LX2006 is an AAVrh10.hFXN gene therapy developed by Lexeo Therapeutics for treating Friedreich ataxia cardiomyopathy.

What is the SUNRISE-FA trial?

SUNRISE-FA is a multicenter, 52-week, dose-ascending, open-label trial evaluating the safety and efficacy of LX2006 in patients with Friedreich ataxia cardiomyopathy.

What are the next steps for Lexeo Therapeutics' LX2006 program?

The next steps include further dose-escalation cohorts in the ongoing trials and additional assessments based on interim data findings.

What significance does the Weill Cornell Medicine trial hold for Lexeo Therapeutics?

Weill Cornell's trial supports Lexeo's research by providing additional data and safety assessments for LX2006, and Lexeo has licensed related intellectual property.