Protagonist Therapeutics Starts Phase 1 Trial of Potential Ulcerative Colitis Treatment PN-10943

Protagonist Therapeutics Starts Phase 1 Trial of Potential Ulcerative Colitis Treatment PN-10943
Protagonist Therapeutics has begun dosing patients in a Phase 1 clinical trial of an oral ulcerative colitis (UC) treatment candidate known as PN-10943, the company announced in a press release. PN-10943 is a gut-restricted blocker of a protein called alpha-4-beta-7 integrin, an adhesion molecule that regulates the migration and homing of lymphocytes (immune cells) to gut-associated lymphoid tissue (GALT). The GALT contains immune T- and B-cells that protect against pathogens. The Phase 1 trial is a randomized, double-blind, placebo-controlled study in up to 80 healthy volunteers. It contains two parts: While the first will explore single ascending doses (100, 300, 1,000, and 1,400 mg) of PN-10493, the second will involve once-daily administration of PN-10943 over 14 consecutive days in ascending dose groups. The trial’s primary objectives are the potential therapy’s safety and tolerability. Other goals include evaluation of pharmacological parameters. According to Dinesh V. Patel, PhD, Protagonist’s president and CEO, the company expects to have top-line results in the first half of 2019. The data will be used to design a Phase 2a trial of PN-10943 in UC patients, expected to begin in the second half of 2019. Preclinical studies have shown that PN-10943 outperformed Protagonist’s PTG-100 — also a gut-restricted blocker of alpha-4-beta-7 integrin — as measured by in vitro
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