M118 - prospects?
Dew have you covered M118 prospects and it's market positioning if it ever comes to market (is this competitor to lovenox?). the below had interesting excerpts...Why has this not taken off in terms of partnership or funding to do take it through Phase 3 ? I believe it is now in 'clinical limbo' for >1 year. By just reading the clinical advantages , it seems like a drug worth phase 3 investment...interesting to find out why no big pharma or other have come forward
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Clinical Perspective on p 1721
It has been demonstrated that LMWHs can be engineered to have certain attributes specifically tailored to the intended clinical setting.12 M118 is a novel LMWH that combines the beneficial properties of UFH and enoxaparin while addressing their respective limitations. It is produced by depolymerization of UFH that is derived from porcine intestinal mucosa. This process significantly reduces molecular weight to a range from 5500 to 9000 Da from the parent UFH molecule and positions the pentasaccharide and thrombin heparin-binding regions on the nonreducing and reducing ends of the molecule, respectively. M118 shows broad anticoagulant activity, including potent activity against factor Xa and thrombin (factor IIa), low polydispersity, subcutaneous bioavailability ({approx}70% in humans), and predictable subcutaneous and intravenous pharmacokinetics. The anti-Xa to anti-IIa ratio of approximately 1.4:1 remains constant over time in vivo. The plasma half-life of M118 is approximately 1 hour after intravenous bolus injection and 2 to 3 hours after subcutaneous injection. Additionally, M118 does not activate platelets, and its anticoagulant activity can be monitored by standard coagulation assays such as activated clotting time (ACT) and activated partial thromboplastin time; in addition, owing to its charge, it is reversible to subtherapeutic levels with protamine sulfate administered at a 1 mg per 100-IU dose.13
Given these properties, M118 may address many limitations of existing anticoagulants. To demonstrate the safety and feasibility of intravenous M118 in the setting of elective PCI, we performed a phase 2 randomized trial comparing 3 doses of intravenous M118 with a standard dose of intravenous UFH.
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