BRP-192

A trailblazing treatment targeting an orphan inflammatory-mediated pain syndrome.

Mast cells are a well-known immune cell responsible for combatting pathogens and mounting allergic responses. Mast Cell Activation Syndrome (MCAS) is a group of disorders where mast cells act abnormally and release excessive amounts of their chemical mediators. As mast cells are found all over the body, this causes widespread, multi-system effects from chronic inflammation, severe pain to anaphylaxis. In Australia, the prevalence of MCAS is not precisely documented, but its effect is profound. Estimates suggest that thousands of Australians may be affected, emphasising the need for research and innovative treatments to address the challenges posed by MCAS.

BRP-192 has a unique formulation containing a compound scientifically known as palmitoyl ethanolamide (PEA). In pre-clinical studies, PEA showcases the ability to down-modulate mast cell activity, which translates to less chemical mediators being released into the body. A lower amount of mediators would mean that the symptoms of MCAS, including neurogenic pain, could be alleviated. As such, BRP-192 offers a new hope to those suffering the symptoms of MCAS.

BRP-192 has already passed through rigorous Phase 1 clinical trials, which demonstrated both its tolerability and safety in humans. The Phase 2 clinical trial is quickly approaching, and set to observe the efficacy of BRP-192. This prospective, randomised, double-blind, placebo controlled parallel group study will aim to enrol a statistically powerful number of participants affected by MCAS. From here, they will be trialed with either an active version of BRP-192 or a placebo for a set amount of time. The primary outcome will be defined as a statistically significant difference between the BRP-192 and placebo arms in the reduction from baseline in average pain perception, as measured on a numerical pain rating scale. Secondary outcomes will also be measured, and further elaborated upon in the study protocol.