InDex Pharmaceuticals and the contract research organization (CRO) Parexel are partnering to manage the overseas Phase 2b CONDUCT dose optimization clinical trial of Kappaproct (cobitolimod) for the treatment of moderate to severe active ulcerative colitis (UC).
Based on the contract between the companies, the first patient in the CONDUCT study will be enrolled during the second quarter of 2017, with topline data expected in late 2018.
CONDUCT is a double-blind, placebo-controlled trial that will evaluate the safety and effectiveness of Kappaproct compared to a placebo in 215 patients with left-sided moderate to severe active UC. Patients will be randomized to four treatment arms, either Kappaproct at different doses and dose frequencies or a placebo, with the aim of optimizing treatment.
The goal is to compare Kappaproct’s safety and effectiveness with other drugs on the market and in late-stage clinical development, as well as demonstrating a substantially higher efficacy than seen in previous studies. All patients will also receive standard of care treatment.
The trial will be conducted across 90 clinical sites in 12 countries: Hungary, Italy, Czech Republic, France, Germany, Romania, Russia, Poland, Serbia, Spain, Sweden and Ukraine.
Each country is undertaking the measures required to have the trial approved by its own regulators and ethics committees. InDex, a Swedish pharmaceutical company, said there will be no sites in the United States due to the high cost per patient.
“We are very pleased to have Parexel as our partner for this important trial with cobitolimod, our lead drug candidate,” Peter Zerhouni, CEO of InDex Pharmaceuticals, said in a press release. “It is a leading global CRO with considerable experience managing multinational clinical studies in inflammatory bowel disease. We are now working together to advance the CONDUCT study as efficiently and quickly as possible.”
Kappaproct (cobitolimod) is a a TLR9 agonist, which enhances its function and leads to the production of anti-inflammatory cytokines — agents that play an important role in reducing inflammation and healing mucosal wounds. TLR9, a Toll-like receptor, is important for protection against intestinal damage and for intestinal repair.
Kappaproct showed potential in clinical proof-of-concept studies in moderate to severe UC, with a favorable safety profile. Data from four placebo-controlled clinical trials indicated the drug had statistically significant effects on the most relevant endpoints for the disease from a regulatory and clinical perspective. Endpoints include pivotal clinical symptoms, such as existence of blood in stool, number of stools, and mucosal healing.
In October 2016, InDex reported positive data from COLLECT (NCT01493960), a placebo-controlled, double-blind, randomized study in European countries that assessed the effectiveness and safety of the Kappaproct in 131 chronic active UC patients who had not responded to available therapy.
In that Phase 3 trial, patients treated with Kappaproct achieved symptomatic remission of 32.1% at week 4, and 44.4% at week 8. Also at week 4, 34.6% of patients treated with Kappaproct had mucosal healing and showed a 30.9% improvement in the Geboes score (a histological score for UC severity), and 21% were in clinical remission with mucosal healing.