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.
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.
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.
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.
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.