Advertisement Momenta seeks clearance to move anticoagulant into clinic - Pharmaceutical Business review
Pharmaceutical Business review is using cookies

ContinueLearn More
Close

Momenta seeks clearance to move anticoagulant into clinic

Momenta Pharmaceuticals has submitted an electronic investigational new drug application to the FDA to begin a phase I human clinical study of M118, the company's lead novel development candidate, for the treatment of acute coronary syndromes.

Momenta developed M118 using its proprietary technology for the detailed analysis and design of complex sugar therapeutics. By isolating, characterizing and engineering the key sugar structures within heparin that contribute to anticoagulation, Momenta designed a proprietary compound that it believes could provide baseline anticoagulant therapy to treat acute coronary syndromes (ACS) patients who require a coronary intervention, as well as those ACS patients who are medically managed, or do not require intervention in order to treat their coronary attack.

M118 is designed to be a reversible and monitorable anticoagulant that has a pharmacokinetic profile similar to a low molecular weight heparin. Thus, M118 is designed to be a therapeutic option that can be used across a variety of ACS treatment paths.

“M118 has the potential to be a significant future advancement in the treatment and management of ACS,” said Alan Crane, CEO of Momenta. “We are very encouraged by our preclinical studies which show that M118 could be a potent agent that provides consistent, flexible and reversible anticoagulant therapy. We look forward to continuing to advance M118 into phase I clinical trials in the coming months.”

Based on preclinical studies, M118 has been shown to be at least as effective in inhibiting clot formation as unfractionated heparin without causing increased bleeding complications. Moreover, preclinical studies found that M118’s anticoagulant activity was reversible by protamine sulfate, unlike currently marketed low molecular weight heparins or direct thrombin inhibitors.