Ramoplanin™ Oral Capsule - Phase 2 clinical program

Ramoplanin™ (CAS: 76168-82-6)

Glycolipodepsipeptide Antibiotic

Ramoplanin™ is a glycolipodepsipeptide antibiotic that is bactericidal for many gram-positive aerobic and anaerobic bacteria, including C. difficile. infection (CDI), vancomycin-resistant enteroccocus (VRE) and methicillin-resistant Staphylococcus aureus (MRSA).

Ramoplanin has also been reported to have activity against C. difficile spores, both in vitro and in an animal model. The sporicidal mechanism is relatively novel, in that the exosporium may be the target for Ramoplanin™ binding, permitting an “ambush” type of vegetative cell killing. The natural history of CDI, regretfully, does not end with successful treatment of the infection. Approximately 25% of patients will experience a recurrence with higher rates among older age groups as well as increasing comorbidities. These relapses are thought to be at least partially due to residual spores in the human gut in clinically cured patients. Elimination of these spores could reduce relapse rates, decreasing the risk of readmission, further treatment requirements or adverse clinical outcomes.

The Ramoplanin oral capsule is currently in a Phase 2 clinical program and has been studied in 12 phase 1 studies, two Phase 2 studies (one in CDI and one in VRE) as well as one Phase 3 study (in CDI)

Nanopharmaceutics believes that Ramoplanin, based on its relatively novel mechanism of action, non-absorbable kinetics (enhanced by dosing to non-inflamed gut mucosa) and established safety profile from prior studies, would fill the unmet need left by the inability of current treatments to kill all the residual CDI spores.

Intellectual Property

Nanopharmaceutics holds world-wide exclusive rights to U.S. patents 5,539,087, 6,720,305, 7,317,001 and related foreign filings.

References (over 180 total)

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