Clinical development

There are several GLP-1 drugs on the market for the management of diabetes but ROSE-010 has unique qualities for use in pain management. Delivered by subcutaneous injection, it can be detected rapidly in blood and starts to show effects after 30 minutes. Other GLP-1 analogues have been optimized for chronic use whilst ROSE-010 is both rapid acting and cleared within a few hours, ideal characteristics for treating episodic pain.

Pain Study:

The efficacy of ROSE-010 in treating pain in all IBS-subtypes was investigated in a placebo controlled trial using 2 doses of ROSE-010. At 1 hour post treatment, there were twice as many  pain relief responders in the ROSE-010 groups as the placebo group.

Click link to publication Hellstrom et al

Further sub-group analysis of the study patients showed that ROSE-010 was most effective in relieving pain in IBS-C and IBS-M. There was also a differential response noted between men and women which has also been observed in studies with treatments for IBS motility symptoms with other drug products.

Click link to publication Touny et al

GI Transit Study:

The motility effects of ROSE-010 on each element of the GI system was investigated in a study population of women with IBS-C. Transit time in the small intestine was increased by ROSE-010 whilst transit time through the colon was decreased, showing the potential to improve motility symptoms in IBS-C as well as pain.

Click link to publication Camilleri et al

Future Studies:

In 2022, we will conduct a placebo controlled Phase IIb study in IBS-C and IBS-M patients. Patients will self-inject and record pain on a standard numeric rating scale commonly used for IBS pain.
Phase III studies will then be carried out for product approval.