JERSEY CITY, N.J., March 19, 2024 – Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the first patient was enrolled in the INSPIRE (Increased Sun Exposure Without Pain In Research Subjects With EPP Or XLP) clinical study (NCT 06144840). INSPIRE is a phase 3 clinical study investigating the efficacy, safety, and tolerability of dersimelagon (MT-7117), in adults and adolescents with erythropoietic protoporphyria (EPP) or X-linked protoporphyria (XLP). Dersimelagon is an investigational treatment under study for its potential to increase the time in sunlight before patients experience prodromal symptoms (i.e., the appearance of initial symptoms such as burning, tingling, itching, or stinging) or fully develop a phototoxic reaction associated with sunlight exposure.
Up to 150 patients with a confirmed diagnosis of EPP or XLP from ages 12 to 75 years may qualify for enrollment. The study measures changes from baseline in average daily sunlight exposure time to first prodromal symptom associated with sunlight exposure between 1-hour post-sunrise and 1-hour pre-sunset at week 16.
There are currently no approved treatments for adolescents for the treatment of the symptoms associated with EPP or XLP beyond sun protection.1
INSPIRE is a phase 3, randomized, double-blind, placebo controlled study sponsored by MTPA. Patients can receive more recruitment information by contacting the United Porphyrias Association (UPA) and submitting a confidential interest form, or by contacting their EPP medical expert to learn if there is a clinical trial site near their home.
About Dersimelagon (MT-7117)
Dersimelagon is a novel synthetic, orally-administered, non-peptide small molecule, which acts as a selective agonist of melanocortin 1 receptor (MC1R) with a potential for being effective to increase pain free light exposure in patients with a history of phototoxicity from erythropoietic protoporphyria (EPP) or X-linked protoporphyria (XLP). Mitsubishi Tanabe Pharma Corporation (MTPC) is developing dersimelagon as a potential treatment option for EPP or XLP. Dersimelagon is an investigational medication and not approved by FDA or any other regulatory authority. Dersimelagon received Fast Track Designation from the U.S. FDA in June 2018 and was granted Orphan Drug Designation in June 2020.
About Mitsubishi Tanabe Pharma America, Inc.
Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). It was established by MTPC to develop and advance our pipeline as well as commercialize approved pharmaceutical products in North America. For more information, please visit www.mt-pharma-america.com or follow us on X (formerly Twitter), Facebook and LinkedIn.
About Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation (MTPC), the pharma arm of Mitsubishi Chemical Group (MCG), is one of the oldest pharmaceutical companies in the world, founded in 1678. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan’s pharmaceutical industry. MCG has positioned health care as its strategic focus in its management policy, “Forging the future”. MTPC sets the MISSION of “Creating hope for all facing illness”. To that end, MTPC is working on the disease areas of central nervous system, immuno-inflammation, diabetes and kidney, and cancer. MTPC is focusing on “precision medicine” to provide drugs with high treatment satisfaction and additionally working to develop “around the pill solutions” to address specific patient concerns based on therapeutic medicine, including prevention of diseases, pre-symptomatic disease care, prevention of aggravation and prognosis. For more information, go to https://www.mt-pharma.co.jp/e/.
Media inquiries:
Media_MTPA@mt-pharma-us.com
1 Dickey A, et al. Evidence-based consensus guidelines for the diagnosis and management of erythropoietic protoporphyria and X-linked protoporphyria. J Am Acad Dermatol. 2023;89(6):1227-1237.