Date: 2016-10-06
Type of information: Treatment of the first patient
phase: 2a
Announcement: treatment of the first patient
Company: Topivert Pharma (UK)
Product: TOP1288
Action
mechanism: kinase inhibitor. TOP1288 is a Narrow Spectrum Kinase Inhibitor (NSKI). NSKIs are a novel class of small molecules targeting key kinases which play pivotal roles as signalling molecules in multiple inflammatory pathways. Inhibition of this combination of kinases leads to potent and broad anti-inflammatory effects in both innate and adaptive immune responses. The compounds are specifically designed to prevent absorption into the circulation, thereby avoiding any propensity for systemic side effects.
Disease: ulcerative colitis
Therapeutic area: Autoimmune diseases - Inflammatory diseases - Digestive diseases
Country: Bulgaria, Czech Republic, Hungary, Latvia, Lithuania, Poland, Ukraine, UK
Trial
details: This Phase 2a, randomised, double-blind, placebo-controlled study will evaluate the safety/tolerability and efficacy of TOP1288 200 mg rectal solution once daily for 4 Weeks in symptomatic ulcerative colitis patients with moderate to severe disease activity. (NCT02888379)
Latest
news: * On October 6, 2016, TopiVert Pharma announced that the first patients have been dosed in its Phase 2a proof-of-concept study to evaluate the safety, tolerability and efficacy of a rectal formulation of TOP1288 in symptomatic
ulcerative colitis patients with moderate to severe disease activity. TopiVert reported encouraging results from a phase 1 study of a rectal formulation of TOP1288 in healthy volunteers earlier this year, and this has subsequently been supported by data from an additional patient cohort. These clinical data, which include encouraging biomarker responses and
negligible systemic absorption, support the concept that TOP1288 has the potential to produce sustained effects in mucosal tissues after local administration, but without the undesirable side effects often seen in ulcerative colitis patients treated with systemically available therapies.
The ongoing Phase 2a study with TOP1288 is a randomised, double-blind, placebo-controlled study to evaluate the efficacy, safety and tolerability of TOP1288 administered once daily for four weeks in symptomatic ulcerative colitis patients with moderate to severe disease activity. The study, which aims to recruit up to 60 patients at sites across eight European countries, is expected to report in the second half of 2017. The current study utilises a rectal formulation of TOP1288, to help demonstrate POC, and a Phase 1 study with an oral formulation of TOP1288, as the intended commercial presentation, is on track to commence in early 2017, with results also anticipated in the second half of 2017.
