US-based biopharmaceutical company Lycera has started the Ulcerative Colitis Phase 2 Study to Assess Remission by Treatment (UPSTART) clinical trial of LYC-30937-Enteric Coated to treat ulcerative colitis (UC).
LYC-30937 is developed as an orally administered, gut-directed ATPase modulator to specifically target and induce cell death (apoptosis) in disease-causing immune cells (T-lymphocytes), while leaving normal cells unaffected.
The randomised, double-blind, placebo-controlled parallel group Phase II trial is expected to include 120 patients who will be randomised on a 1:1 basis, to be administered with either LYC-30937-EC or placebo.
The patients will be treated for a period of eight weeks with an additional two-week safety follow-up.
The trial has been designed to evaluate the safety and efficacy of LYC-30937-EC when administered orally on a once-daily basis to patients affected by ulcerative colitis.
It is primarily focused on achieving a clinical remission of disease of the patients after eight weeks, determined by the basis of modified Mayo score (MMS).
It will also evaluate the safety in the administration of LYC-30937-EC.
Lycera president and CEO Paul Sekhri said: "The initiation of the Phase II clinical trial of LYC-30937-EC is an important milestone in Lycera's continued progress, and is one of several clinical studies we plan to initiate in the second half of 2016 as we build our portfolio of novel immune modulatory treatments.
"Based upon the results of our preclinical and Phase I studies, we believe LYC-30937-EC may possess key advantages for patients, including localised therapy at the site of disease, and the potential for reduced systemic exposure and side effects.
“Our candidate also offers the convenience of once-daily oral dosing. Despite progress in treatment options for patients with UC, we believe there is still significant need, one where LYC-30937-EC may play an important future role."
Preclinical studies have suggested the efficacy of LYC-30937 in treating ulcerative colitis, as well as in other autoimmune diseases.