Protagonist Therapeutics: Administration of PN-943 was 'safe and well tolerated'
Protagonist Therapeutics announced results from the initial single ascending dose part of the Phase 1 study of PN-943, an oral, gut-restricted alpha-4-beta-7 integrin specific antagonist in development for the potential treatment of inflammatory bowel disease. Results of the first clinical study of PN-943 in a randomized, double-blind, placebo-controlled, dose escalation study in healthy volunteers demonstrated that administration of PN-943 was safe and well tolerated, with no reported serious adverse events. The pharmacokinetic and pharmacodynamic parameters were consistent with the design of PN-943 as a gastrointestinal-restricted alpha-4-beta-7 integrin antagonist. "These dose-finding results are consistent with the preclinical properties of PN-943, including superior target engagement as compared with prior compound PTG-100," commented Samuel Saks, M.D., Protagonist Chief Medical Officer. "PN-943 has been designed with superior potency and a longer half-life of dissociation. In addition, PN-943 applies the oral, gut-restricted, integrin antagonist approach that has been validated by previous studies in ulcerative colitis patients with PTG-100."