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Merck Initiates Phase 2 Trial of MK-6194 in Vitiligo

Merck is recruiting for a Phase 2 trial of MK-6194, a novel investigational interleukin-2 mutein (IL-2M) inhibitor in patients with non-segmental vitiligo.

Administered via a subcutaneous injection, MK-6194 selectively expands regulatory T cells without activating cytotoxic immune cell counterparts. IL-2M is a protein that helps regulate the body’s immune response, and MK-6194’s mechanism may help rebalance the dysregulated immune responses of patients with a wide range of autoimmune diseases.

Researchers are also studying MK-6194 in several other immune disorders, including moderate-to-severe atopic dermatitis, ulcerative colitis, and systemic lupus erythematosus (SLE).

“This drug has a unique mechanism of action,” says vitiligo study investigator lltefat Hamzavi, MD, a dermatologist at Hamzavi Dermatology/Dermatology Specialists, with offices throughout Michigan, and senior staff physician at Henry Ford Health System’s Department of Dermatology in Detroit, MI. “It works on IL2m, which affects the regulatory function of T-cells.”

By contrast, the only other approved medication for non-segmental vitiligo works along the Janus kinase (JAK)-signal transducer and activator of transcription proteins (STAT)  signaling pathway. “A large unmet need exists among vitiligo patients, and the more treatments we have, the greater the percentage of vitiligo patients who can be treated,” he tells TDD.

“There is no itch or pain associated with vitiligo, but the psychosocial effects are very extensive,” he says. “Depression is common in patients with vitiligo, and society is now aware of how important it is to treat vitiligo.”

Treating vitiligo requires patience and expectation management. “Once you rebalance the immune milieu, it takes a long time for melanocytes to migrate and repigmentation to occur,” he says. The process can take more than one year. Setting this expectation is important for this potential treatment for vitiligo, he adds.

Learn more about Merck’s REGINA vitiligo study and trial locations here.