Research & Development

Gasteroenterology

Melokinex™ for Post Operative Ileus

Melokinex™ is a clinical candidate for the treatment of post operative ileus ('POI'), developed in China by Botanic Century (Beijing) Ltd ('BCCL'), a botanical drug development company in which Phynova has a 45% equity stake. POI is a form of bowel hypomotility associated with surgery and/or the use of opiate painkillers that is widely seen after abdominal surgery and is an important cause of post-operative morbidity and delayed hospital discharge. BCCL’s candidate has shown promising efficacy in preclinical studies targeting increased bowel movement in conditions where the bowel motility has been impaired.

In addition to extensive preclinical safety and efficacy data, a dosing-regime clinical study was recently completed in China.  The study aimed to investigate the optimum time for dosing for Melokinex™.  Three regimes were tested and Melokinex™ was administered:

  • 6 and 12 hours after surgery or,
  • 12 and 24 hours after surgery or,
  • 24 and 48 hours after surgery. 

 

 

The study showed that the ideal timing for dosing was 12 and 24 hours after surgery.  All dosing groups showed a trend for improvement over historical control data, with the 12/24hours group showing most improvement in the two key endpoint (time to first flatus – 63 hours improvement over control data; and time to first bowel movement – 55 hour improvement over control data).  Based on the data obtained, a larger, placebo control, proof of concept Phase 2b trial is underway and aims to evaluate further the safety and efficacy of Melokinex™ in patients suffering from POI as a result from abdominal surgery. Results are expected in the forth quarter of 2011.



Timing to first passing flatus after surgery. Group B showed trend for most improvement with mean time of 54.7 hours. Median time was 48.2 hours (Q1=42.9hrs; Q3=61.3hrs). This data compares favourably with historic ileus data, where first flatus in patients receiving standard hospital care occurs after 118 hours

 

 

Timing to first bowel movement (BM) after surgery. Group B showed trend for most improvement with mean time of 72.8 hours. Median time was 48.2 hours (Q1=44.0hrs; Q3=84.9hrs). This data compares favourably with historic ileus control data, where first BM in patients receiving standard hospital care occurs after 128.1 hours.