Ritter Pharmaceuticals has completed patient enrolment in the pivotal Phase III Liberatus clinical trial of RP-G28 for the treatment of lactose intolerance (LI).
Recruitment has been closed at approximately 555 participants, which is slightly higher than the initially expected 525 subjects. Liberatus is being conducted at more than 30 centres in the US.
Lactose is a sugar present in milk and milk-containing foods, and RP-G28 is being developed to alleviate lactose intolerance symptoms by driving the growth of lactose-metabolising bacteria that minimises lactose-derived gas production.
The multi-centre, randomised, parallel-group Phase III trial will assess the safety, efficacy and tolerability of RP-G28.
The primary endpoint of the double-blind, placebo-controlled trial is a mean change in LI symptom composite score 30-days following therapy, while secondary endpoints include evaluation of LI signs and symptom outcomes to determine continued treatment benefit.
Top-line results from the Liberatus study are expected to be available in the fourth quarter of this year.
Ritter Pharmaceuticals CEO Andrew Ritter said: “The large number of patients interested in participating in the trial highlights the clinical need for new treatment options in this patient population.
“As we near data readout and continue to build our commercialisation strategy for RP-G28, we look forward to advancing our ongoing discussions with potential partners for the continued further development and potential launch of this exciting product candidate.”
The company reported positive results from a Phase IIb/III trial of RP-G28 in August 2017. Data demonstrated a clear drug effect with a significant and clinically meaningful reduction in LI symptoms.