Imcyse’s peptides work by priming cytolytic T cells to recognize and destroy those immune cells attacking the pancreas beta cells.
With 7% of the population suffering from some form of autoimmune disease, the immunotherapy market is hot with companies trying to bring cures to the market. Belgium’s Imcyse is developing modified synthetic peptides as a potential treatment, and its Phase II study for Type 1 Diabetes (T1D) is already showing promise.
T1D is caused by immune cells going rogue, killing off the insulin-producing cells in the pancreas, leaving the body unable to regulate glucose levels. Often striking during childhood or teen years, around 1.6 million Americans are living with the chronic, hard-to-manage disease. That number is expected to more than triple over the next 30 years.
Imcyse’s peptides work by priming cytolytic T cells to recognize and destroy those immune cells attacking the pancreas beta cells. An interim analysis from 17 patients treated with Imotope showed promising results over the placebo including an increasing number of the CD4+ T cell “soldiers,” expansion of anti-inflammatory markers, no treatment-induced FOXP3+ regulatory T cells, and prevention of the expansion of antigen-specific CD4+ T cells with pathogenic signature.
With the European-based study at a midpoint in recruitment, the U.S. Food and Drug Administration and Australia’s regulatory counterpart have approved Imcyse to initiate its Imotope study in their countries. These arms will be included in the current study, which should have recruitment completed by mid-summer this year. A pediatric trial is also in the works, as T1D affects an estimated 652,000 children ages 0-14 worldwide, with over one hundred thousand new diagnoses in that age group occurring each year.
Promising treatments for T1D patients are desperately needed. Less than one-third of the population affected by the disease are able to consistently achieve target levels of their blood glucose. People with T1D are more likely to get heart disease, stroke, kidney failure, high blood pressure, blindness and nerve damage.
Though much needed, the path for treating T1D is not an easy one. Many developing immunotherapies have failed along the way.
A high-potential drug from Provention Bio was shot down last summer with a CRL from the FDA. A study had shown that a single 14-day course of Provention’s teplizumab delayed clinical disease and insulin dependence by at least 2 years in pre-symptomatic patients with stage 2 T1D. The FDA stated a failure to show pharmacokinetic (PK) comparability in the clinical trials as their reasoning. Further meetings in the fall have provided a potential path forward, but approval has not yet been granted.
While T1D is Imcyse’s flagship program, it’s not the only potential for treatment with Imotopes. A Phase I trial is beginning this year for multiple sclerosis, with an Imotope developed to stop immune attacks on the CNS to enable uninterrupted nerve transmission. Last February, Pfizer renewed its 2018 partnership with Imcyse to develop an Imotope to target the immune response that drives rheumatoid arthritis. Programs for neuromyelitis optica and celiac disease are also in the works at Imcyse.
