The first patient has been dosed in a phase 1/2 clinical trial to evaluate the safety, optimal dose, and initial efficacy of Imotope™ IMCY-0141 for the treatment of multiple sclerosis (MS), as published in a press release by Imcyse, the developers of the treatment.
“The dosing of the first patient in this study is an important milestone for Imcyse, as we advance our second [Imotope] into the clinic. We are excited to progress our pipeline of next-generation targeted immunotherapies for the treatment of [relapsing-remitting MS], which is an often devastating and highly unpredictable disease,” Denis Bedoret, chief executive officer of Imcyse said.
The open-label phase 1 portion of the trial will evaluate the safety of 3 dose levels in 12 patients with relapsing-remitting MS. The double-blind, randomized, controlled, phase 2 arm of the trial will feature an adaptive design for dose optimization to investigate the immune response to IMCY-0141 along with disease markers.
Overall, the study plans to recruit around 150 patients. Imcyse expects interim results in the fourth quarter of 2023 if planned recruitment milestones continue to be met.
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“Backed by promising preclinical data and the encouraging clinical results we have observed across our Imotope platform, we believe IMCY-0141 has the potential to substantially slow down or even halt the progression of [MS] and, if treatment is begun early enough, to allow patients to live with minimal impact from the disease,” Bedoret said.
IMCY-0141 is a synthetic peptide designed to stop demyelination and the progression of MS. Its design utilizes Imcyse’s proprietary platform and is based on a dominant autoantigen, myelin oligodendrocyte glycoprotein. Imotopes stimulate the production of the cytolytic cluster of differentiation 4 T cells that can halt the attack on the central nervous system.
Testing in several preclinical MS models yielded immune responses that support the proposed mechanism of action and also demonstrated a memory response that would increase make treatment long-lasting and require less frequent dosing.
“The unmet need for effective and convenient therapies with fewer side effects remains high. Imcyse’s technology has the potential to shift the treatment paradigm for this autoimmune disease, intervening earlier in the disease process with a potentially immense impact to patients. We look forward to seeing the results of IMCY-0141 from this first-in-human study,” said Patrick Vermersch, MD, PhD, chairman of the IMCY-MS-001 trial steering committee.
Imcyse announces first patient dosed in adaptive phase 1/2 clinical trial of ImotopeTM IMCY0141 for multiple sclerosis. News release. Imcyse; April 13, 2022.