IM Therapeutics Announces First Patient Dosed in Phase 1 Study of its Lead Drug for Type 1 Diabetes

ImmunoMolecular Therapeutics, Inc. recently announced the dosing of the first patient in a Phase 1 study of IMT-002, an oral small molecule drug designed as a selective HLA-DQ8 blocker for the treatment of type 1 diabetes (T1D).  The trial is designed as a single ascending dose (SAD) Phase 1a study of healthy subjects to demonstrate drug safety and tolerability.

“The initiation of this clinical trial is a great milestone for IM Therapeutics and shows the outstanding progress our team has made in developing oral HLA-targeted drugs,” said Nandan Padukone, PhD, CEO of IM Therapeutics. “We believe IMT-002 is the first of multiple targeted agents that we intend to develop as first-in-class drugs for genetically preselected patients in autoimmune disease.”

The clinical trial will enroll 28 healthy volunteers to evaluate four escalating single doses of IMT-002.  The study will compare active drug versus placebo for safety, tolerability and pharmacokinetic (PK) profiles.  Following the current study, IM Therapeutics intends to study safety and efficacy with multiple ascending doses in type 1 diabetes patients preselected for DQ8-positive status.

“We are excited that our many years of research on HLA targets and treating type 1 diabetes has brought us to launch this novel drug into human studies,” said Peter Gottlieb, MD, Founder and CMO of IM Therapeutics. “We hope to show that preselecting patients with specific HLA genes can be an important direction for tailored patient care in T1D and other autoimmune conditions.”

IMT-002 has been developed as a selective HLA-DQ8 blocker based on extensive computational work, in vitro and in vivo characterization.  An enantiomer of IMT-002, L-methyldopa, which is an FDA-approved drug for treating hypertension, was studied as a tool drug in a Phase 1b study reported previously. Results of the study showed effective inhibition of DQ8 activity in new onset type 1 diabetes patients who had the DQ8 gene variant.  Several in vivo studies indicate that IMT-002, which unlike L-methyldopa is not metabolized physiologically, can have more potency against DQ8 activity while retaining the safety profile of its enantiomer.

IM Therapeutics is a clinical stage company developing personalized medicines for autoimmune diseases by building oral drug therapies against human leukocyte antigen (HLA) variants that confer high risk of disease. The Company platform screens millions of compounds for optimal docking within HLA proteins together with rational drug design and bioassays to develop targeted therapeutic candidates.  In addition to its lead drug, IMT-002, directed at HLA-DQ8 activity for treatment of type 1 diabetes, the Company is building a broad pipeline of drugs against HLA targets such as DQ2, DR3 and DR4 in a range of autoimmune disorders including celiac disease. For more information, visit