TopiVert Begins Phase 1 Study of Oral TOP1288 as Colitis Treatment

TopiVert Begins Phase 1 Study of Oral TOP1288 as Colitis Treatment
The first participant has been dosed in a Phase 1 American study evaluating TopiVert Pharma's oral version of TOP1288 as a treatment for ulcerative colitis (UC). The study will assess TOP1288's safety, tolerability, pharmacokinetics and pharmacodynamics in healthy volunteers. Pharmacokinetics refers to the body's absorption, distribution, metabolism, and excretion of a substance. Pharmacodynamics refers to its biological and physiological effects. TopiVert is also conducting a randomized, double-blind, placebo-controlled Phase 2a trial (NCT02888379) in Europe. It will evaluate the effectiveness, safety, and tolerability of a 200-mg rectal formulation of TOP1288 administered once a day for four weeks to 60 people with moderate to severe symptomatic ulcerative colitis. The rectal-formulation study is aimed at guiding the development of the oral formulation that TopiVert hopes to market. The company expects results from both the oral and rectal studies in the second half of the year. “We are delighted to have commenced the clinical evaluation of an oral formulation of TOP1288 as our intended commercial presentation,” Ajay Duggal, TopiVert’s chief medical officer, said in a press release. “The Phase 1 study will evaluate the ability to deliver TOP1288 to the colon by the oral route, as well as assessing safety and tolerability of the formulation. In parallel, a rectal formulation of TOP1288 is being evaluated in a Phase 2a study to demonstrate proof of concept in UC patients.” “Both studies will report [results] in the
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