CONCORD, Mass.– Tremeau Pharmaceuticals announced today that Gurnet Point Capital has agreed to fund the clinical development of its investigational drug TRM-201 (rofecoxib), including a Phase III trial of TRM-201 for hemophilic arthropathy (HA). Gurnet Point Capital, a private investment firm focused on the healthcare and life sciences sectors, is Tremeau’s primary investor.
HA is a painful and degenerative joint disease caused by recurrent intra-articular bleeding in patients with inheritable bleeding disorders. Although HA is the leading cause of morbidity in patients with hemophilia,1 there currently are no medications in the United States indicated to treat joint pain in people with bleeding disorders, and opioids are the most frequently used prescription treatment.2
“Patients with hemophilic arthropathy need an alternative to opioids,” said Bradford C. Sippy, Chief Executive Officer of Tremeau. “TRM-201 could be this much-needed option, and the investment and support from Gurnet Point Capital will enable us to make our vision a reality.”
Rofecoxib is a COX-2 selective non-steroidal anti-inflammatory drug (NSAID). Previously marketed as VIOXX, rofecoxib was shown to have no effect on bleeding time3, and was the only COX-2 selective NSAID ever approved in the US to demonstrate a reduced risk of gastrointestinal bleeding versus a traditional NSAID in a controlled trial.4 VIOXX was voluntarily withdrawn from the market in 2004 due to concerns about cardiovascular safety. It has since been demonstrated in multiple, often industry-independent studies that cardiovascular safety is a dose- and duration-dependent risk of all NSAIDs.5-9
“Hemophilia treatment has advanced significantly but hemophilic arthropathy hasn’t gone away,” said David Moore, Partner at Gurnet Point Capital. “We made this investment because we see an opportunity to provide a pain management option that’s long overdue to the bleeding disorder community.”
Dr. Tyler Buckner, a practicing hematologist in Denver who has published widely on hemophilia treatment, said: “For many of my patients with bleeding disorders, the joint pain they experience has a profound negative impact on their lives. The withdrawal of VIOXX took away an important treatment option for many of our patients.”
In a recent End of Phase II Meeting, the FDA agreed that Tremeau has established comparable levels of rofecoxib exposure between TRM-201 and the previously marketed version of VIOXX, and the company can proceed into a Phase III study.