Tisento emphasizes two venues that drive patient -oriented focus on the patient -oriented focus

TISENTO in the therapeutic development workshop “Primary mitochondrial diseases”, which is organized by the Reagan studall Foundation for the FDA on May 22, 2025

Tisento to sponsor the first external patient -oriented pharmaceutical development meeting, which is dedicated to Melas on February 10, 2026; To lead co -action

Cambridge, Mass., May 14, 2025 (Globe Newswire) – TiSento Therapeutics Today Announced upcoming Opportunities to Collaborate With Patient Advocates, Leading Clinicians, and Regulators to Optimize Therapeutic Development for Mitochondrial Diseases, Including The Rare Mitochondrial Disease Melas (Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-Like Episodes).

“The inclusion of the knowledge that was taken from listening to patients and the integration of the perspectives of all critical stakeholders are fundamental for our approach of pharmaceutical development,” said Peter Hecht, Chief Executive Officer from Tisento. “We look forward to promoting the patient-oriented therapeutic development in mitochondrial diseases in two important events. We will share important findings in connection with the design of our phase 2b prizm study in Melas in the primary mitochondria diseases, which were organized by the Reagan studall foundation at the FDA profit documentation. Melas and are proud of it, To support coactions to throw light on the uncovered needs in this rare state.

Primary mitochondrial diseases of public workshops

Chad Glasser, Pharm.d., Senior Director of Clinical Research near Tisento, presents Tisento's approach to the development of Zagociguat for the treatment of Melas, a primary mitochondrial disease, in a public workshop. Dr. Glasser will provide important findings in the overcoming of challenges in connection with the development of medication for rare, heterogeneous diseases, including the selection of the selection of the selection of the evaluations and endpoints of the company in the current phase -prizm -prizm study of the company in adults with Melas, how knowledge from Tisentos Melas patient interview from Tisento.

The workshop is organized by the Reagan-Stound Foundation for the FDA in cooperation with the US Food and Drug Administration and combines patient lawyers, academies, drug practitioners and drug developers in order to examine the possibilities to optimize therapies to treat therapies to the treatment of participation in the development of the development of mitemics to treat. The Reagan-Stiftung for the FDA is an independent organization of 501 (3), which was created by the congress to modernize product development, accelerate innovation and improve product safety. The foundation serves as a decisive management between the FDA and the public and offers the FDA a means to interact directly with stakeholders, including industry and consumers.

Virtual event details
Date: Thursday, May 22, 2025
Time: 10 a.m. to 4 p.m. et
Registration: Free; Register here

Co-option-managed patient development with patients

Tisento sponsors the first external patient development (EL-PFDD), which is devoted to the systematic acquisition of patient perspectives on life with Melas and the most important symptoms in the development of drug candidates. Under the co-action, the EL PFDD of the FDA, the pharmaceutical industry and other important stakeholders should offer the opportunity to hear directly from patients, their families, caregivers and patients who are most important for them, the effects on the daily life of patients and the experience of patients with currently available disease lawyers. There is no treatments approved by the FDA especially for Melas. MitoAction plans and organizes the meeting; Tisento offers financial support and is not involved in planning or content.

Virtual event details
Date: Tuesday, February 10, 2026
Registration: Free (registration details that are announced); Contact MitoAction at info@mitoaction.org to get updates

About the Prizm study

Prizm – A PHase 2b RAndomized, placebo -controlled attempt INvest ZAgociguat in MELAS-Reviews the effectiveness and security of oral zagociguat 15 mg or 30 mg compared to placebo if it is administered daily for 12 weeks with participants with genetic and phenotypically defined Melas for 12 weeks. The prizm study has a crossover design, with two 12-week treatment periods separated by a 4-week wash-up. All participants receive Zagociguat and placebo in the other during one of the 12-week periods. Participants who complete the study can be considered for an open label extension study.

Prizm is a global study in which approximately 44 participants in the mitochondrial diseases in the USA, the USA, Italy, Germany, Great Britain, in Australia and Canada will take part. You can find more information at www.tisentotx.com/prizm or Klinicaltrials.gov (NCT06402123). Interested people can also contact their doctors to achieve participation details.

About Zagociguat

Zagociguat is once a daily, oral examination medicine with a clinical stage that positively influences the potential to influence both peripheral and central nervous system manifestations of mitochondria diseases. Zagociguat stimulates soluble guanylat cyclase (SGC), an enzyme that can be found in every cell in every tissue of the body and is part of a system of cellular mechanisms that control critical physiological functions including the neuronal function and blood flow.

Zagociguat is a first-class SGC stimulator planted in the brain, cell paths in Melas that balanced dysregulated cellular paths. By restoring cellular functions that support mitochondria, Zagociguat can help to restore production mitochondrial energy and the physiological function.

In a phase -2a study in patients with Melas, Zagociguat showed a favorable security profile, exposure in the entire body, including in the central nervous system, and improvements in neuronal function, the mitochondria function and blood flow in the brain. Zagociguat is currently evaluated in the phase -2b -prizm study as the treatment of Melas.

You can find more information at www.tisentotx.com/our-science.

About Tisento therapeutic agents

Tisento Therapeutics, a privately owned biotech company, develops new medicines for the treatment of diseases with considerable need, starting with Melas and other genetic mitochondria diseases. Ti sento means “I hear you in Italian”; Our approach to innovation begins with listening to patients and dealing with what we learn, decisive measures that influence our research and clinical programs.

TiSento is guided by a top-class internal team of biopharma veterans and a comprehensive external network of experts from experts, patient representative groups, researchers, industry leaders and other close employees who are partners in our mission to develop sensible treatments for mitochondria diseases.

Find out more on our website www.tisentotx.com or connect with us at LinkedIn, Facebook, X (@tisentotx) or bluesky.

contact

Tisento Media Relations
Jessi Rennekamp, ​​Astrior Communications
E -mail: jessi@astriorcomms.com