Epiphany Biosciences Initiates Valomaciclovir Study For Shingles

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Herpes, Shingles

Epiphany Biosciences announced that the first patient was enrolled in a Phase 2b clinical trial with valomaciclovir (EPB-348) for the treatment of herpes zoster, also known as shingles. Valomaciclovir is a highly potent anti-viral with enhanced delivery and bioavailability.

"The initiation of this dose-finding study is an important milestone in our development of valomaciclovir," said Fred Volinsky, MD, Chief Executive Officer. "Shingles, especially in the elderly population, can pose a serious threat to quality of life. Despite the approval of the adult zoster vaccine, we believe that the potential market for effective zoster medications will double in size based on the published vaccine efficacy rates and the aging of the baby boomers."

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"There are roughly one million cases of herpes zoster in the United States annually and current therapy requires multiple dosing, anywhere from three to five times a day. These dosing schedules can be problematic for patient populations who are already taking multiple medications for other co-morbid conditions," stated Brian Murphy, MD, Chief Medical Officer. "This clinical trial is designed to examine the safety and efficacy of once-daily valomaciclovir against an active comparator, three times daily valacyclovir, and is adequately powered to assess a number of pivotal outcomes."

"Advancing a therapy that is conducive to better compliance is sorely needed in this therapeutic space," noted Dr. Stephen Tyring, Professor of Medicine at the University of Texas Health Science Center in Houston and principal investigator for the study. "In light of the improved pharmacodynamic profile offered by this drug, it is important to study it in larger, diverse populations that can be affected by herpes zoster."

The number of elderly patients at-risk for this disease is expected to increase dramatically over the next decade as the world population ages. "While we are working to advance valomaciclovir to become the next global brand for the management of shingles, we are pleased that this compound also exhibits activity both in vitro and in vivo against other types of viruses. We plan to explore these potential broad therapeutic possibilities given the spectrum of this anti-viral profile," said Dr. Volinsky.

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