US-based biotechnology firm Kineta has enrolled the first patient in a Phase Ib clinical trial of its lead drug ShK-186, a novel immune-sparing therapeutic, being developed to treat several autoimmune diseases.
Derived from the toxic tentacles of the sun anemone, Stichodactyla helianthus, ShK-186 is a selective and potent blocker of the voltage-gated Kv1.3 potassium channel.
Claimed to be the first Kv1.3 specific inhibitor advanced into the clinic, ShK-186 is a synthetic peptide with a novel mechanism of action that targets autoimmune diseases without broadly suppressing the immune system.
Data secured from preclinical trials and the recently completed Phase Ia trial suggest that ShK-186 will have activity across a variety of autoimmune diseases and may be well-tolerated.
Patients enrolled in the two-phase trial will be patients refractory to disease modifying drugs and biologics.
In the first stage, healthy participants will be given escalating doses of ShK-186 until the maximum tolerated or the biologically effective dose is reached, and they will be randomised to one of four dose levels in a 28-day cycle.
While the second stage of the trial will include about two dosing cohorts treated at doses selected from the first stage and will assess both safety and effect on disease in patients with active psoriatic arthritis (PsA).
Kineta president and CEO Charles Magness said there is a significant unmet medical need for patients with psoriatic arthritis, and ShK-186 represents a potential new therapy for these patients.
"Demonstration of drug activity in PsA will provide Kineta with development options to investigate ShK-186 in other autoimmune diseases, such as rheumatoid arthritis, lupus, multiple sclerosis and psoriasis," Magness said. "We expect clinical results from this study in mid-2014."
Psoriatic arthritis is a chronic inflammatory disease that occurs when the immune system attacks healthy cells and tissues.