Imcyse completes enrollment in Phase 1 trial testing IMCY-0141 for RRMS

Imcyse has completed patient enrollment and initial dosing in a Phase 1 clinical trial evaluating IMCY-0141, its next-generation immunotherapy, in people with relapsing-remitting multiple sclerosis.

The study, the first portion of a Phase 1/2 trial called IMCY-MS-001 (NCT05417269), is an open-label trial evaluating three doses of IMCY-0141 in up to 12 adults with relapsing-remitting MS (RRMS). The first patient was dosed last year.

“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,” Denis Bedoret, CEO of Imcyse, said in a press release.

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Multiple sclerosis (MS) is an autoimmune disease caused by the immune system mistakenly attacking the myelin sheath, a protective coating around nerve fibers that helps them send messages efficiently. Damage to myelin interferes with normal nerve cell function, leading to disease symptoms.

While more than 20 therapies are approved to treat MS, mostly relapsing forms of the disease, the majority works to promote a general suppression of the immune system, increasing the risk of significant side effects, such as infections.

Imcyse, however, is working to develop therapies that specifically target the portion of the immune system that contributes to a given autoimmune condition. Using its proprietary Imotope technology platform, the company creates small proteins, based on the targeted proteins, that stimulate the patient’s immune system to block the autoimmune response.

How IMCY-0141 works

IMCY-0141 is an Imotope whose structure is based on the myelin oligodendrocyte glycoprotein (MOG) protein, a basic component in myelin that often is the target of autoimmune attacks in MS.

The therapy stimulates the production of a type of immune cell called cytolytic T-cells, which are primed to attack and kill other immune cells targeting the MOG protein and causing damage to the body’s own structures. The rest of the immune system, however, remains intact.

“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,” Bedoret said.

Previous studies in preclinical mouse models have shown the therapy is effective at inducing the proposed immune response. Moreover, it also promotes immunological memory, meaning that some immune cells remain in the body and control the cells that promote the anti-MOG response.

IMCY-0141 may provide long-lasting effects

This indicates the therapy may provide long-lasting effects, requiring infrequent doses, like a vaccine, according to the company. Also, if the treatment is started early in the disease course, patients may live with minimal disease symptoms.

The two-part, IMCY-MS-001 trial is testing IMCY-0141 in up to 150 adults with RRMS, at a site in the Republic of Moldova. In the Phase 1 part, participants are receiving IMCY-0141 (at doses of 150, 450, or 1,350 micrograms), given as two subcutaneous, or under-the-skin, injections on each arm.

This part’s main goal is to determine the therapy’s safety, but researchers also will look at preliminary signs of efficacy, to determine the best doses for further testing. So far, analyses of the two lowest dose levels have revealed no safety issues.

“The pre-specified Independent Data Monitoring Committee analyses to date have found no safety concerns, and we expect the final … review of the data from the third and highest dose level from our Phase 1 trial by the end of this year,” said Jean Van Rampelbergh, PhD, chief clinical development officer at Imcyse.

“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,” Van Rampelbergh said.

The Phase 2 part will enroll 138 participants, who will be assigned randomly to receive one of three doses of IMCY-0141, a placebo, or dimethyl fumarate (sold as Tecfidera and generics) for 36 weeks (about eight months).

The main goal is to determine the total number of lesions on brain scans from weeks 12 to 36. Secondary measures include changes in relapse rates, disability levels, and markers of nerve damage, as well as safety and changes in vital signs.

“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,” he added.