IM Therapeutics Launches Phase 1b Trial of Lead Drug IMT-002 in Autoimmunity; Announces Positive Safety Data of Phase 1a Study

Excerpt from the Press Release:

WOBURN, Mass.–(BUSINESS WIRE)–ImmunoMolecular Therapeutics, Inc. (“IM Therapeutics”), a leading innovator in the field of precision medicine for autoimmune diseases, today announced it has launched a Phase 1b study as a multiple ascending dose (MAD) trial. The study is in patients who have type 1 diabetes (T1D), an as yet incurable autoimmune disorder that affects nearly 1.6 million Americans, and who also have a specific genetic trait known as HLA-DQ8, present in about 60% of T1D patients. Variants in certain genes called human leukocyte antigens (HLA) are known to play a strong role in activating an autoimmune response.

The Phase 1b trial will enroll 30 patients between the ages of 18 and 45 into four groups, each of which will have six subjects receiving varying doses of IMT-002 over a two-week duration. The remaining six subjects will receive placebo. The study will compare drug versus placebo for safety, tolerability and pharmacokinetic (PK) profiles over the two-week duration of dosing and a follow-up one week after dose completion. In addition, the study will assess pharmacodynamic (PD) activity with a blood-based assay that measures the ability of IMT-002 to block DQ8 presentation of “self-antigens” or the body’s own proteins, such as insulin or gluten, that can result in autoimmunity.

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