Lactose is a sugar present in milk and milk-containing foods. Credit: Marco Verch.

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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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 large number of patients interested in participating in the trial highlights the clinical need for new treatment options.”

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.