Potential MS therapy IMP761 to be tested in healthy volunteers
Initial data from Immutep's Phase 1 trial in Netherlands expected by year's end
Immutep has been cleared to start a Phase 1 clinical trial in the Netherlands to test IMP761, its experimental antibody therapy for autoimmune diseases such as multiple sclerosis (MS), in healthy volunteers.
The first-in-human Phase 1 clinical trial seeks to assess the safety and pharmacological properties of IMP761. A total of 49 participants are expected to enroll at the Centre for Human Drug Research in Leiden. Recruitment is anticipated to start in the next couple of months, and initial data should be available by year’s end.
“The regulatory and ethical clearance for the first-in-human trial of IMP761 is a significant milestone for Immutep and marks an important step in the development of this novel autoimmune disease approach,” Frédéric Triebel, MD, PhD, chief scientific officer of Immutep, said in a company press release.
MS and other autoimmune conditions are caused by an erroneous inflammatory response that targets the body’s own tissues and organs. Several immune cells are involved in this inflammatory attack, but most autoimmune conditions are marked by an excess activity of immune T-cells.
IMP761 designed to reduce T-cell levels
IMP761 is designed to reduce T-cell levels to restore immune balance by targeting and activating an inhibitory receptor, called LAG-3, that’s found at the surface of these cells.
In lab and animal studies, the molecule has been shown to reduce T-cell growth and activation, and also lower the production of pro-inflammatory molecules that can further contribute to the progression of autoimmune conditions.
Immutep is currently developing IMP761 for rheumatoid arthritis, type 1 diabetes, and MS, among other autoimmune diseases.
The upcoming Phase 1 clinical trial will assess IMP761 in two parts. First, participants will receive a single infusion of the investigational dose, or a placebo, at ascending doses. Then, ascending doses of IMP761 or a placebo will be given via multiple infusions over a certain treatment period. Neither participants nor treating physicians will know who is receiving active treatment and who is on the placebo.
The trial will assess IMP761’s safety, pharmacokinetics (how it moves into, through, and out of the body), and pharmacodynamics (its effects on the body). The researchers will also use a unique challenge model to explore how IMP761 affects T-cell responses in early stages of development.
“Molecules such as LAG-3… hold significant potential in the treatment of autoimmune diseases,” said Bent Deleuran, MD, a professor of immunology at Aarhus University in Denmark. “It is exciting to see IMP761 move into the clinical setting to evaluate the potential of this new immunotherapy to address autoimmune diseases.”
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