Kallyope, a late-stage biotechnology company leveraging unique insights into neural signaling pathways to develop innovative therapies for migraine and metabolism, today announced positive results from a Phase 2b study of the company’s lead candidate elismetrep, an oral Transient Receptor Potential Melastatin 8 (TRPM8) antagonist being studied for the acute treatment of migraine. In the study, elismetrep delivered a favorable clinical profile through its novel mechanism, supporting its potential as a new therapeutic option for the large number of patients who are suffering from the debilitating effects of migraine.
“Migraines impact one in six Americans, leading to debilitating pain, nausea, and sensitivity that can strike at a moment’s notice and prevent people from participating fully in their lives. Migraines are estimated to have an economic impact of $36 billion annually in the U.S. alone,” said Jay Galeota, CEO and President, Kallyope. “As the only TRPM8 antagonist being studied for the acute treatment of migraine, elismetrep has demonstrated the potential to bring relief and a sense of control back to the lives of millions of people who suffer from migraines. We look forward to initiating registrational studies in 2026 and working with great urgency to bring this important potential therapy to patients in need.”
The double-blind, placebo-controlled, Phase 2b dose-ranging study randomized 431 patients in the United States. Key measures were standard for clinical studies in the acute treatment of migraine and included pain freedom, pain relief, and freedom from most bothersome migraine-associated symptom. The performance of elismetrep across all endpoints was competitive with marketed therapies. No safety signals were observed, and the drug was well tolerated. Tolerability-related adverse events were mostly mild.
“Our Phase 2b data strongly support elismetrep’s ability to deliver on key measures in the assessment of migraine drugs and potentially become an important part of the standard of care,” said Brett Lauring, MD, PhD, Chief Medical Officer, Kallyope. “We look forward to sharing additional details on the novel TRPM8 mechanism, elismetrep, and expanded clinical analyses at an upcoming medical meeting.”
Currently, only around 30% of patients achieve good outcomes with any particular medication used in the acute treatment of migraine. This creates a highly dissatisfied population that switches between medications to seek relief. Elismetrep targets Transient Receptor Potential Melastatin 8 (TRPM8), an ion channel protein with a strong genetic association to migraine and has demonstrated robust efficacy in preclinical models of migraine. TRPM8 is expressed in trigeminal sensory neurons involved in migraine which are distinct from those targeted by existing therapies such as antagonists of calcitonin gene-related peptide (CGRP), suggesting potential as a combination treatment.
“Migraines are among the leading causes of disability globally, and suboptimal treatment of migraine through existing drug classes results in reduced quality of life for millions of people worldwide,” said Peter Goadbsy, MD, PhD, King Abdullah University of Science and Technology, Saudi Arabia, and King’s College London, UK. “Given the variable and inadequate response to existing therapies, patients and physicians urgently need new approaches to managing this debilitating condition, making elismetrep a compelling addition to the innovation pipeline in migraine.”
