elismetrep (MT-8554) / Mitsubishi Tanabe, Kallyope - LARVOL DELTA

CRISPR-Cas9 mediated editing of starch branching enzyme, SBE2 gene in potato for enhanced resistant starch for health benefits. (PubMed, Front Genome Ed) - "K301, K302, K303, K304, K305, K306, derived from distinct events, exhibited deletions and substitutions in the target exons...Furthermore, 1H-NMR study demonstrated a substantial decline in branch chain elongation in amylopectin, and thus a low degree of branching in a range of 1.15%-3.66% was reported in mutant lines, relative to the wild type (5.46%). The present study demonstrated the efficacy of CRISPR-Cas9-mediated mutagenesis of starch biosynthetic genes to develop high-amylose potato lines with elevated resistant starch content for improved health benefits."

Journal • Gene Therapies

Kallyope Announces Positive Results from Phase 2b Study of Elismetrep for the Acute Treatment of Migraine (PharmiWeb) - "Full data to be presented at a major medical meeting in 2026; Kallyope plans to initiate registrational studies in mid-2026...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...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."

New trial • P2b data • Migraine

In silico mining of sn-1,3 regioselective Rhizomucor miehei lipase homolog with strict pH sensitivity from Cordyceps militaris. (PubMed, Food Chem) - "Molecular dynamic simulation revealed that the extended C-terminus (P270-K304) may endow rmCML2 with unexpected pH sensitivity by changing the H-bond network to expose the active site in pH-dependent manner. The sn-1,3 regioselectivity and pH sensitivity are expected to confer dual advantages of rmCML2 for processing lipid-related foods that require pH-dependent enzymatic conversion (e.g., cheese ripening)."

Journal

A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study of Elismetrep (K-304) in the Treatment of Migraine (clinicaltrials.gov) - P2 | N=431 | Completed | Sponsor: Kallyope Inc. | Active, not recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Aug 2025 | Trial primary completion date: Dec 2025 ➔ Aug 2025

Trial completion • Trial completion date • Trial primary completion date • CNS Disorders • Migraine • Pain

A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study of Elismetrep (K-304) in the Treatment of Migraine (clinicaltrials.gov) - P2 | N=400 | Active, not recruiting | Sponsor: Kallyope Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Migraine • Pain

A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study of Elismetrep (K-304) in the Treatment of Migraine (clinicaltrials.gov) - P2 | N=400 | Recruiting | Sponsor: Kallyope Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Migraine • Pain

A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study of Elismetrep (K-304) in the Treatment of Migraine (clinicaltrials.gov) - P2 | N=400 | Not yet recruiting | Sponsor: Kallyope Inc.

New P2 trial • CNS Disorders • Migraine • Pain

Exploratory Study of MT-8554 in Subjects With Painful Diabetic Peripheral Neuropathy (clinicaltrials.gov) - P2 | N=156 | Completed | Sponsor: Mitsubishi Tanabe Pharma Corporation | Active, not recruiting ➔ Completed | Trial completion date: Jun 2023 ➔ Nov 2022 | Trial primary completion date: Mar 2023 ➔ Nov 2022

Trial completion • Trial completion date • Trial primary completion date • Diabetic Neuropathy • Pain • Peripheral Neuropathic Pain

Exploratory Study of MT-8554 in Subjects With Painful Diabetic Peripheral Neuropathy (clinicaltrials.gov) - P2 | N=144 | Active, not recruiting | Sponsor: Mitsubishi Tanabe Pharma Corporation | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetic Neuropathy • Pain • Peripheral Neuropathic Pain

Exploratory Study of MT-8554 in Subjects With Painful Diabetic Peripheral Neuropathy (clinicaltrials.gov) - P2; N=144; Recruiting; Sponsor: Mitsubishi Tanabe Pharma Corporation; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Diabetic Neuropathy • Pain • Peripheral Neuropathic Pain

Exploratory Study of MT-8554 in Subjects With Painful Diabetic Peripheral Neuropathy (clinicaltrials.gov) - P2; N=144; Not yet recruiting; Sponsor: Mitsubishi Tanabe Pharma Corporation

Clinical • New P2 trial • Diabetic Neuropathy • Pain • Peripheral Neuropathic Pain

Long-term Safety and Efficacy Study of MT-8554 in Postmenopausal Women With Vasomotor Symptoms (clinicaltrials.gov) - P2; N=190; Completed; Sponsor: Mitsubishi Tanabe Pharma Development America, Inc.; Active, not recruiting ➔ Completed; N=100 ➔ 190; Trial completion date: Mar 2020 ➔ Nov 2019

Clinical • Enrollment change • Trial completion • Trial completion date

Long-term Safety and Efficacy Study of MT-8554 in Postmenopausal Women With Vasomotor Symptoms (clinicaltrials.gov) - P2; N=100; Active, not recruiting; Sponsor: Mitsubishi Tanabe Pharma Development America, Inc.; Trial completion date: Jul 2019 ➔ Mar 2020; Trial primary completion date: Apr 2019 ➔ Dec 2019

Clinical • Trial completion date • Trial primary completion date