Investment will enable Tremeau to advance the clinical development of TRM-201 (rofecoxib)
Tremeau has gained agreement with FDA to initiate a pivotal Phase III trial for TRM-201 in hemophilic arthropathy (HA), a painful and debilitating joint disease
If approved, TRM-201 would potentially be the first new oral non-opioid pain treatment in over 15 years, and the first specifically indicated for HA
CONCORD, Mass.--(BUSINESS WIRE)-- 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a reduced risk of gastrointestinal bleeding versus a traditional NSAID in a controlled trial.4 VIOXX was voluntarily withdrawn from the market in 2004 due to concerns about cardiovascular safety.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.
Tremeau plans to initiate a registrational trial for TRM-201 in early 2021. Information on the trial can be found at www.resetHAstudy.com.
Wedbush PacGrow served as Tremeau’s investment advisor.
TRM-201 is an investigational drug containing rofecoxib. Previously marketed as VIOXX, rofecoxib was shown to be a highly potent cyclooxygenase-2 (COX-2) selective non-steroidal anti-inflammatory drug (NSAID) with a
well-established efficacy profile. Rofecoxib has been shown to have no effect on bleeding time relative to placebo and was the only COX-2 selective NSAID ever approved in the U.S. to demonstrate a reduced risk of gastrointestinal bleeding versus a traditional NSAID in a controlled trial.
Nonsteroidal anti-inflammatory drugs (NSAIDs), including rofecoxib, cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. NSAIDs, including rofecoxib, are contraindicated in the setting of coronary artery bypass graft (CABG). NSAIDs, including rofecoxib, cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
About Tremeau Pharmaceuticals
Tremeau is a Massachusetts-based pharmaceutical company focused on providing non-opioid pain treatments for well-defined patient populations with significant unmet needs.
Tremeau’s unique approach to acute and chronic pain in select conditions is rooted in the mechanism of action, documented efficacy, and clinically differentiated profile of COX-2 selective NSAIDs.
Tremeau’s lead clinical stage product, TRM-201 (rofecoxib), is a COX-2 selective NSAID and a potent non-opioid analgesic with a well-established benefit-risk profile.
VIOXX is a registered trademark of Tremeau Pharmaceuticals, Inc.
- Forsyth A, Gregory M, Nugent D, et al. Haemophilia Experiences, Results and Opportunities (HERO) Study: survey methodology and population demographics. Haemophilia 2014; 20;44-51.
- Witkop M, Lambing A, Divine G, Kachalsky E, Rushlow D, Dinnen J. A national study of pain in the bleeding disorders community: a description of haemophilia pain. Haemophilia 2012; 18: e115–19.
- US Food and Drug Administration. VIOXX (Rofecoxib) U.S. Prescribing Information May 09, 2016, (accessed October 1, 2019).
- US Food and Drug Administration. Analysis and recommendations for agency action regarding non-steroidal anti-inflammatory drugs and cardiovascular risk. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders
- Cannon CP, Curtis SP, FitzGerald GA, et al. Cardiovascular outcomes with etoricoxib and diclofenac in patients with osteoarthritis and rheumatoid arthritis in the Multinational Etoricoxib and Diclofenac Arthritis Long-term (MEDAL) programme: a randomised comparison. Lancet 2006; 368: 1771–81.
- Nissen SE, et al. Cardiovascular Safety of Celecoxib, Naproxen, or Ibuprofen for Arthritis. N Engl J Med 2016;:2519-2529.
- Coxib and traditional NSAID Trialists’ (CNT) Collaboration. Vascular and upper gastrointestinal effects ofnon-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials. Lancet 2013; 382: 769–79.
- Patrono C, Baigent C. Nonsteroidal anti-inflammatory drugs and the heart. Circulation 2014;129:907–916.
- McGettigan P, Henry D. Cardiovascular risk with non-steroidal anti-inflammatory drugs: systematic review of population-based controlled observational studies. PLoS Med 2011; 8: e1001098.
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Source: Tremeau Pharmaceuticals