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CeNeS Pharmaceuticals plc: Update on Successful Phase III results,announced on Lead Product M6G

own in previous studies that the dose of M6G required to provide analgesia immediately after surgery is three times that of morphine. In accordance with this, the M6G022 trial was designed such that M6G was available in a 3:1 ratio to morphine during the titration to comfort phase. Thereafter pain relief was provided using patient controlled analgesia (PCA) in a dose ratio of 2:1 (M6G:morphine). The secondary data announced today demonstrated again that in the initial phase after surgery the dose of M6G required to titrate patients to comfort was 3 times that required for morphine on a weight basis. However, during the prolonged PCA phase, the ratio was lower (0-24 hours 1.6:1; 24-48 hours 1.4:1). This shows that patients in the M6G group made less demands for pain relief after titration to comfort, as assessed by presses on the PCA button. These data support the hypothesis that M6G has a longer duration of analgesic action than morphine.

Sedation/safety

The M6G022 data shows that M6G patients experience lower levels of sedation compared to those on morphine for up to 48 hours. This is another advantage of M6G that has been indicated from previous clinical data and adds to the considerable package of potential benefits to patients and clinicians. The M6G patients also showed no adverse cardiovascular effects which again supports CeNeS claims that M6G has a very good safety profile.

Partnering strategy

There is a clear need for new drugs that can improve the quality of pain management currently given to patients by standard morphine regimens across the world and M6G is well positioned to address that market. Since the announcement of the successful data last week significant interest has been expressed by Pharma companies in reviewing the large M6G data package that CeNeS has assembled. CeNeS is confident that agreements can be finalised with partner(s) based on the existing set of clinical trial data. Concluding these deals will generate
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