elismetrep liquid-filled softgel capsule / Kallyope - LARVOL DELTA

Liquid-Filled Softgel Capsule Formulation Results in More Rapid Absorption which is Predicted to Improve Efficacy and Result in Earlier Onset of Pain Relief (Businesswire) - "Elismetrep absorption was rapid and accelerated with the LSGC formulation (median time to maximum concentration [Tmax] = 1-h) compared to the DFC formulation (median Tmax = 2.5-h). While absorption was more rapid with the LSGC formulation, the overall extent of absorption was similar and there was no meaningful difference in tolerability between the two formulations...Model-based simulations with the PK data from the biocomparison study predicted ~50% and ~40% improvements in placebo-corrected response rates for 2-h pain freedom and 2-h freedom from the most bothersome symptom, respectively, as well as earlier onset of efficacy with the LSGC vs the DFC."

P1 data • Migraine

New Elismetrep Formulation (Yahoo Finance) - "Kallyope has developed a new liquid-filled softgel capsule (LSGC) formulation of elismetrep that results in substantially more rapid absorption compared to the formulation used in Phase 2b. The LSGC formulation will be used in future trials and is expected to result in earlier onset of migraine relief and enhanced efficacy at 2 hours (the timepoint where the primary endpoints for registrational trials are assessed). Full pharmacokinetic data from the LSGC formulation will be presented at an upcoming medical meeting in 2026."

Clinical data • Pipeline update • PK/PD data • Migraine

Kallyope’s Phase 2b Study of Elismetrep, A Novel Approach for Treating Migraine, Presented at the American Academy of Neurology Annual Meeting (Yahoo Finance) - "In the primary and supporting analyses for 2h pain freedom, response rates for elismetrep 20 mg vs. placebo were 17.6% vs. 9.1% (odds ratio [OR]=2.1, P=0.0650) (e-Diary only) and 19.6% vs. 9.1% (OR=2.4, nominal P=0.0344) (All Data) respectively. Response rates for 2h freedom from most bothersome symptom for elismetrep 20 mg vs. placebo were 38.3 % vs. 24.2% (OR=1.9, nominal P=0.0425). Response rates for 2h pain relief for elismetrep 20 mg vs. placebo were 58.8% vs. 42.4% (OR=1.9, nominal P=0.0293)...There were no serious adverse events (AEs). The incidence of AEs was dose dependent."

P2b data • Migraine