Kallyope is advancing its lead migraine drug to pivotal trials after it has shown to be competitive with marketed therapies in a Phase IIb trial.
In the study (NCT06848075), elismetrep, an oral transient receptor potential melastatin 8 (TRPM8) antagonist, delivered a favourable clinical profile across all endpoints that was competitive with marketed therapies. Kallyope said the data supports its potential as a new therapeutic option for acute migraine.
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Key endpoints included pain freedom, pain relief, and freedom from most bothersome migraine-associated symptom.
The double-blind, placebo-controlled, Phase IIb dose-ranging study enrolled 431 patients in the US. Kallyope said that no new safety signals were observed, and the drug was well tolerated, with adverse events (AEs) being mostly mild.
While the company did not release specific data, it said this would be presented at an upcoming medical meeting in 2026.
Kallyope CEO and president Jay Galeota said: “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.”
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By GlobalDataGaleota added that the company will initiate registrational studies in mid-2026.
Elismetrep acts by targeting TRPM8, which is expressed in trigeminal sensory neurons involved in migraine. Other approved therapies target calcitonin gene-related peptide (CGRP) such as Teva Pharmaceuticals’ Ajovy (fremanezumab), with Kallyope believing that by targeting a different mechanism, elismetrepcould act as a combination treatment.
The migraine market across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) is poised to grow at a compound annual growth rate (CAGR) of 6% from $9.2bn in 2023 to $16.4bn in 2033, according to GlobalData’s recently published report, ‘Migraine: Seven-Market Drug Forecast and Market Analysis’.
GlobalData is the parent company of Clinical Trials Arena.
This migraine success will be a welcome development for Kallyope after a difficult 2025 for its pipeline. Last month, it terminated a trial of its other investigate migraine therapy, K-645, after interim analysis determined it was unlikely to meet its endpoints. This came after the company reported disappointing data from its weight loss candidates earlier this year.
