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Wintermute Biomedical Receives Ethics Approval for Phase Ib Clinical Trial of Solexan in Shingles Patients

Richard Powell  2 min readupdated 28 Dec 2023

Breaking Ground in Shingles Treatment: Wintermute Biomedical Advances to Clinical Trials … Wintermute Biomedical is excited to report that in December 2023 they have received full approval to conduct a Phase IB clinical trial in Australia using their first-in-class topical antiviral, Solexan. Solexan has been developed over the last 12 years by Wintermute Biomedical as a novel topical antiviral for herpes viruses including shingles, herpes simplex 1 (cold sores) and herpes simplex 2 (genital herpes).

The ZosterEase clinical trial will follow a double-blind placebo-controlled format, testing the safety and proof-of-concept efficacy of topical Solexan in 30 shingles patients. The trial will commence patient recruitment in January 2024, and will be conducted in Australia. The primary objectives of the trial are to evaluate the safety and tolerability of Solexan while also gauging potential efficacy in reducing shingles pain and accelerating lesion healing. The anticipated completion time for the trial is approximately 7-12 months. “With an increase in the aging population, the need for an effective topical treatment that reduces shingles pain is growing year over year.” Said Dr. Alyce Mayfosh, Chief Scientific Officer, “While an effective shingles vaccine exists, adoption of the vaccine has not been widespread with approximately 30% of adults over the age of 60 fully vaccinated in the United States. Furthermore, individuals under the age of 50 are not recommended to receive the vaccine, leaving a large portion of the adult population susceptible to the development of shingles. This fact, coupled with a lack of effective treatments, means many individuals will suffer from shingles pain.”

“Shingles is caused by the reactivation of the Varicella Zoster Virus (VZV) in nerves and is characterized by severe pain that can drastically reduce the quality of life for those affected.” Said Dr. Thomas Rau, Wintermute’s Chief Executive Officer. “We are very excited to expand our program into a clinical trial with shingles patients that are suffering. We’re confident that topical Solexan is both safe and effective against herpes virus infections, and this trial is critical step in demonstrating that effect.”

Leading shingles physician and Clinical Advisor to Wintermute Biomedical, Professor Myron Levin, has stated that “Shingles is a major health burden in the U.S. (1.3 million cases a year) and is equally prevalent in every region of the world. There is a great need for an effective treatment that will safely reduce the consequences of shingles.”

In response to the critical unmet need in shingles patients, Wintermute Biomedical remains committed to developing and advancing new technology and treatments that address the widespread impact of shingles by reducing pain and enhancing lesion healing.

https://www.wintermutebiomedical.com

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