Imcyse Announces First Patient Dosed in Adaptive Phase 1/2 Clinical Trial for Multiple Sclerosis

Imcyse recently announced the first patient has been dosed in the adaptive Phase 1/2 clinical trial evaluating Imotope IMCY-0141 in patients with relapsing-remitting multiple sclerosis (RRMS). Subject to meeting the planned recruitment milestones, Imcyse expects to report interim results in Q4 2023.

“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 RRMS, which is an often devastating and highly unpredictable disease,” said Denis Bedoret, Imcyse CEO. “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 multiple sclerosis and, if treatment is begun early enough, to allow patients to live with minimal impact from the disease.”

The IMCY-MS-001 Phase 1/2 trial will evaluate IMCY-0141 in adult patients with RRMS. The Phase 1 open-label, dose escalation part of the trial is expected to enroll up to 12 patients and will evaluate the safety of three dose levels. The Phase 2 expansion arm of the trial will be double-blind, randomized, and placebo controlled with an adaptive design. The study aims to include approximately 150 patients in total and will assess immune responses while continuing to evaluate disease marker activity. In addition, Phase 2 will allow for dose optimization in preparation for registration studies to follow.

IMCY-0141 is a synthetic peptide based on MOG (Myelin Oligodendrocyte Glycoprotein), a dominant autoantigen, designed to stop the progression of multiple sclerosis (MS) and the destruction of the myelin sheath protecting the nerves. Imotopes stimulate the expansion of a population of antigen-specific cytolytic CD4 T cells that reset the body’s autoimmune response. By specifically interrupting the autoantigen-driven disease pathway, Imotopes™ halt the attack on the central nervous system. IMCY-0141 has shown promising results in several MS preclinical models, demonstrating an immune response that supports the proposed mode of action. Notably, in those models, Imotopes also demonstrated induction of a memory response so that the treatment effect is long-lasting and require less frequent dosing regimens.

“Although the therapeutic landscape for MS has changed significantly over the past 15 years, today’s treatments are still associated with significant adverse events and compliance challenges,” said Prof. Patrick Vermersch, MD, PhD, Vice President for Research in Biology and Health at the University of Lille, France, and Chairman of the IMCY-MS-001 trial steering committee. “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.”

Multiple Sclerosis (MS) induces damage to the proteins protecting the nerves, also called nerve sheath demyelination, which exposes the underlying nerves and can lead to paralysis. Symptoms include muscle weakness, weak reflexes, tremors, and muscle spasms. More than three million people globally have been diagnosed with MS. The disease can affect people as young as 15 years old, and women are twice as likely as men to contract MS. The true cause of the disease is unknown; however, a combination of hereditary and environmental factors is believed to enable the autoimmune attack.

There is no cure for MS. MS treatments typically focus on speeding recovery from attacks, slowing disease progression and managing symptoms. Although current medications are effective in reducing the frequency of disease relapse, they are also associated with significant side effects and compliance challenges. Thus, there remains a major need for new treatments with a more favorable safety profile that can slow or even stop disease progression.

Imcyse is a clinical-stage biopharmaceutical company pioneering the development of a new class of active specific immunotherapies for the treatment of severe chronic autoimmune diseases. The company’s unique technology platform allows it to locally target immune cells involved in the destruction of the diseased organ. This platform is based on the administration of Imotopes, which are specifically modified peptides, allowing for the generation of cytolytic CD4 T-cells that specifically eliminate autoantigen-presenting cells and autoantigen-specific lymphocytes involved in the disease pathways. Imcyse’s approach, sustained over time, may help to prevent and treat diseases with no current therapeutic options and to potentially cure patients without impairing their immune defenses. The company has established proof of concept in several indications and has completed its first clinical trial in type 1 diabetes with promising results. Beyond type 1 diabetes and MS, Imcyse is developing a pipeline of Imotopes for the treatment of several autoimmune diseases. Imcyse was founded as a spin-off from the Catholic University of Leuven and is headquartered in Liège, Belgium. The MS preclinical program has been supported by the Walloon Region through the Sclerovac grant AR 7649. For more information, visit www.imcyse.com.