ClearPoint Neuro Congratulates Neurona Therapeutics on Dosing of Initial Subject in First Clinical Trial of Regenerative Human Cell Therapy in Adults with Drug-Resistant Focal Epilepsy

Rhea-AI Summary

ClearPoint Neuro (CLPT) congratulated partner Neurona Therapeutics for administering the first dose in their Phase 1/2 clinical trial of NRTX-1001, aimed at treating mesial temporal lobe epilepsy (MTLE). This innovative regenerative neural cell therapy could address a significant unmet need as 25-35% of epilepsy patients experience ongoing seizures despite existing treatments. The trial will include an open-label dose-escalation study involving up to 10 patients. ClearPoint continues to expand its role in enabling novel therapies for complex neurological disorders.

Positive

• Successful initiation of the Phase 1/2 clinical trial for NRTX-1001.
• Focus on addressing an unmet need in epilepsy treatment.
• Potential for breakthrough regenerative cell therapy for MTLE.

Negative

• None.

SOLANA BEACH, Calif., June 29, 2022 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global therapy-enabling platform company providing navigation and delivery to the brain today congratulates partner Neurona Therapeutics on dosing the first patient in their Phase 1/2 clinical trial of its lead program NRTX-1001, in a first-in-human epilepsy study. Harish Babu, MD, PhD, Assistant Professor of Neurosurgery at SUNY Upstate Medical University administered the first dose.

An estimated three million Americans have epilepsy, and 25 to 35 percent live with ongoing seizures despite dozens of approved drugs on the market. NRTX-1001 is a regenerative neural cell therapy delivered as a single dose and designed to provide long-term secretion of gamma-aminobutyric acid (GABA), a key inhibitory neurotransmitter, to repair hyper-excitable neural networks associated with mesial temporal lobe epilepsy (MTLE), the most common form of focal epilepsy in adults. The first stage of the trial is an open-label dose-escalation study in up to 10 patients with MTLE.

“There is a huge unmet need for more effective treatments to help achieve seizure freedom and durable quality of life for patients with drug-resistant focal epilepsy,” stated Jeremy Stigall, Vice President, Biologics and Drug Delivery. “Our team is proud to partner with Neurona to support their Phase 1/2 clinical trial of what could potentially be a breakthrough regenerative cell therapy for MTLE.”

About ClearPoint Neuro

ClearPoint Neuro’s mission is to improve and restore quality of life to patients and their families by enabling therapies for the most complex neurological disorders with pinpoint accuracy. Applications of the Company’s current product portfolio include deep brain stimulation, laser ablation, biopsy, neuro-aspiration, and delivery of drugs, biologics, and gene therapy to the brain. The ClearPoint^® Neuro Navigation System has FDA clearance, is CE-marked, and is installed in over 60 active sites in the United States, Canada, and Europe. ClearPoint Neuro is partnered with approximately 45 biologics/pharmaceutical companies and academic centers, providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, more than 5,000 cases have been performed and supported by the Company’s field-based clinical specialist team, which offers support and services to our customers and partners worldwide. For more information, please visit www.clearpointneuro.com

Forward-Looking Statements

Statements herein concerning the Company’s plans, growth and strategies may include forward-looking statements within the context of the federal securities laws. Statements regarding the Company's future events, developments and future performance, as well as management's expectations, beliefs, plans, estimates or projections relating to the future, are forward-looking statements within the meaning of these laws. Uncertainties and risks may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: the impact of the COVID-19 pandemic and the measures adopted to contain its spread; future revenue from sales of the Company’s ClearPoint Neuro Navigation System products; the Company’s ability to market, commercialize and achieve broader market acceptance for the Company’s ClearPoint Neuro Navigation System products; and risks inherent in the research and development of new products. More detailed information on these and additional factors that could affect the Company’s actual results are described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, and the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2022, both of which have been filed with the Securities and Exchange Commission.

FAQ

What is ClearPoint Neuro's recent achievement with Neurona Therapeutics?

ClearPoint Neuro announced the first patient dosing in Neurona Therapeutics' Phase 1/2 clinical trial for NRTX-1001, targeting mesial temporal lobe epilepsy.

What is the purpose of the NRTX-1001 clinical trial?

The NRTX-1001 trial aims to evaluate a regenerative neural cell therapy designed to reduce seizures in patients with drug-resistant focal epilepsy, specifically mesial temporal lobe epilepsy.

How many patients are involved in the NRTX-1001 trial?

The trial includes up to 10 patients in an open-label dose-escalation study.

What condition does NRTX-1001 aim to treat?

NRTX-1001 is focused on treating mesial temporal lobe epilepsy (MTLE), the most common form of focal epilepsy in adults.

What challenges does ClearPoint Neuro face according to the press release?

The press release mentions potential uncertainties and risks related to COVID-19, product marketing, and the research and development of new products.