Biotech Values

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MNTA M118 - Novel Heparin Compound Shows Promise in Patients Undergoing PCI

Key Points:
•New heparin agent well tolerated in stable CAD patients
•Noninferior to unfractionated heparin with respect to composite endpoints
•Larger, more definitive trials needed to elucidate role of new agent

Results Encouraging

In an e-mail communication with TCTMD, William J. French, MD, of Harbor-UCLA Medical Center (Torrance, CA), said the study of the new agent is interesting and added that being able to measure with ACT is important for any low-molecular-weight heparin.

“The overall results are encouraging, with low incidence of bleeding and transfusion,” he said. “A new agent would be most acceptable with lower bleeding rates than UFH or even bivalirudin.”

Dr. Rao added that when something does go wrong, the ability to measure M118 adds clarity about whether the drug itself is not having the intended effect and more needs to be given, or if there is some other issue that has nothing to do with the drug.

In terms of comparisons with bivalirudin, Dr. Rao said any new anticoagulant in the PCI realm would need to be tested against the agent. “That’s definitely something that needs to be done in larger definitive trials. Bivalirudin is an excellent agent. It reduces bleeding complications significantly, and it is statistically noninferior to heparin or heparin [plus GPI] in terms of reducing ischemic events. But many of the challenges of bivalirudin have centered on this idea of noninferiority,” he said. “I think most of us who use it have come to accept that there is a slight lift in ischemic events, but we are saving on the bleeding side. But really the question is, can we do better? We don’t have evidence from the EMINENCE trial that M118 is it, but certainly it can’t hurt to have more agents to study.”

http://www.tctmd.com/show.aspx?id=89522