Imcyse Announces Completion of Enrollment in Phase 1 Clinical Trial of Imotope^TM IMCY-0141 for the Treatment of Multiple Sclerosis 

Liège, Belgium, September 13, 2023 – Imcyse, a clinical-stage biopharmaceutical company pioneering the development of a new class of active and specific immunotherapies for the treatment of severe autoimmune diseases, today announced completion of enrollment and initial dosing in the Phase 1 portion of its adaptive Phase 1/2 clinical trial, IMCY-MS-001. The Phase 1 open-label, dose escalation part of the study is assessing the safety of three doses of Imotope™ IMCY-0141 in patients with relapsing-remitting multiple sclerosis (RRMS).

“Completing enrollment in the Phase 1 trial with IMCY-0141 is an important step towards bringing this therapy to patients suffering from RRMS, a disease with devastating and often unpredictable symptoms,” said Denis Bedoret, CEO of Imcyse. “IMCY-0141 is now the second Imotope™ from Imcyse’s proprietary platform to progress to the next clinical stage, demonstrating our commitment to finding new therapies for patients suffering from severe, chronic autoimmune diseases.”

Jean Van Rampelbergh, CCDO of Imcyse, added: “The pre-specified Independent Data Monitoring Committee analyses to date have found no safety concerns, and we expect the final outcome of the IDMC’s review of the data from the third and highest dose level from our Phase 1 trial by the end of this year. The results from the Phase 1 portion of the trial will allow further refining of the Phase 2 protocol design and selection of the most appropriate doses to be evaluated. We look forward to continuing to explore the role of IMCY-0141 in the treatment of multiple sclerosis, which, if applied early-on in the course of disease, could slow down or even halt its progression, leading to a potentially curative approach.”

IMCY-0141 is being evaluated in an ongoing Phase 1/2 trial, IMCY-MS-001, in adult patients with RRMS. Following the Phase 1 dose escalation portion, the Phase 2 expansion arm of the trial will be designed to assess immune responses, while continuing to evaluate disease marker activity. In addition, it will allow for dose optimization in preparation for registration studies.

For more information on this clinical trial, please visit: , NCT05417269.

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ABOUT IMCY-0141

IMCY-0141 is the Company’s second clinical-stage compound. This Imotope™ is designed based on MOG (Myelin Oligodendrocyte Glycoprotein) with the aim to halt the progression of multiple sclerosis (MS) by stopping the body’s immune system from attacking the central nervous system and disrupting undesirable autoimmune responses that drive the destruction of the myelin sheath protecting the nerves.

IMCY-0141 has shown promising results in several MS preclinical models, demonstrating an immune response that supports the proposed mode of action and inducing a memory response so that the treatment effect is long-lasting and requires less frequent dosing regimens. Also, if treatment is begun early enough, it has the potential to allow patients to live with minimal impact from the disease.

ABOUT MULTIPLE SCLEROSIS (MS)

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 favourable safety profile that can slow or even stop disease progression.

ABOUT IMCYSE

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 the local targeting of immune cells involved in the destruction of the diseased organ. This platform is based on the administration of Imotopes™, which are synthetic peptides encompassing a T-cell epitope and an active thioredox motif. Imotopes™ generate 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, has completed its first clinical trial in type 1 diabetes with promising results and is expecting top-line data from the fully enrolled Phase 2 study in this indication in 2024. A Phase 1/2 clinical trial in multiple sclerosis (MS) was initiated in April 2022. Beyond type 1 diabetes and MS, Imcyse is developing a pipeline of Imotopes™ for the treatment of several autoimmune diseases in large and rare disease indications. Imcyse was founded as a spin-off from the Catholic University of Leuven and is headquartered in Liège, Belgium.

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