Oppilan Pharma Announces Positive Phase 1 Data for its Ulcerative Colitis Drug OPL-002 at Digestive Disease Week 2020 Virtual Scientific Program
Potential best-in-class profile for an oral sphingosine-1-phosphate receptor modulator
- Dose-dependent reduction in circulating lymphocytes -
- Rapid lymphocyte recovery after cessation of dosing -
- Phase 2 study in ulcerative colitis patients in 4Q 2020 -
ENCINITAS, Calif. and CAMBRIDGE, United Kingdom, June 23, 2020 (GLOBE NEWSWIRE) -- Oppilan Pharma, Ltd., a clinical-stage biopharmaceutical company focused on developing novel small molecule therapeutics for the treatment of autoimmune diseases, today announced that positive top-line results from a Phase 1 study of OPL-002, an oral, once-daily sphingosine 1-phosphate (S1P) receptor modulator, were recently presented at the Digestive Disease Week® (DDW) 2020 Virtual Scientific Program.
In the Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) study, OPL-002 was well tolerated in a once-daily administration to healthy subjects for up to 28 days. The study was designed to evaluate the safety, tolerability, dose-response, pharmacokinetics and pharmacodynamics of OPL-002 compared to placebo. 88 subjects were randomized into the double-blind, placebo-controlled trial. There were no serious adverse events. None of the subjects had liver function test elevations, pulmonary function or ocular exam abnormalities, or other notable safety findings.
In the MAD study, once-daily dosing of OPL-002 led to a dose-dependent steady state reduction in absolute lymphocyte count of up to 65%. Lymphocyte counts returned to normal or were rapidly returning to normal by 72 hours after the last dose of OPL-002.
There was no clinically significant first dose heart rate reduction during treatment for up to 28 days. In the MAD study, with doses up to 45 mg (preceded by 7 days of dose titration), the maximum decrease in heart rate from baseline after the initial dose at the target level was less than 4 beats per minute.
“The clean safety profile of OPL-002 in Phase 1, combined with potent and sustained lymphocye reduction and a rapid on and off rate, sets OPL-002 apart from other S1P modulators in development,” said Chris Krueger, Chief Executive Officer of Oppilan. “We are excited to advance OPL-002 into a Phase 2 study in moderate-to-severe ulcerative colitis patients to demonstrate its differentiated efficacy and safety and establish OPL-002 as a true best-in-class drug for IBD and other indications.”
“The new class of oral S1P modulators represent a significant advancement in the treatment of IBD,” said William Sandborn, M.D., Chief of the Division of Gastroenterology of the University of California San Diego and Chairman of Oppilan’s Clinical Advisory Board. “As with any new class of pharmacologic agents, there may be differences in pharmacologic structure that impact the safety and efficacy profile for individual members of the class. I am very encouraged by the robust lymphocyte lowering and rapid lymphocyte recovery that OPL-002 has demonstrated in Phase 1. The strong pharmacodynamic signal, combined with the safety and tolerability data, position OPL-002 as a promising new potential treatment for IBD.”
The poster can be viewed in the “ePosters and ePapers” section of the DDW website. Poster can be found HERE.
Details for the presentation are as follows:
Poster Number: TU1852
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