Cambridge, UK-based CeNeS says that its loss for the first six months of the year jumped 34% from the year-earlier period to £3.1 million, as a substantial rise in sales was not enough to buffer the planned increase in clinical development activities.
Turnover from out-licensing activities jumped to £27,000 from £13,000, while R&D costs rocketed 75% to £2.1 million on increased expenditure on development and pre-clinical programmes. The company says it expects this growth in R&D spend to continue through the rest of the year as its potential new pain drug, M6G (morphine-6-glucuronide), enters its second Phase III trial in Europe.
Alongside its financial results, the firm also reported that it has initiated patient recruitment into a Phase III study of M6G in Europe, assessing the agent for the treatment of pain following procedures such as bowel and major gastrointestinal surgery. The trial, which is scheduled to run until 2006, aims to enroll 428 patients in at least six countries in the European Union.
The group also intends to conduct supportive clinical evaluation, such as Phase I drug distribution trials, in addition to this Phase III study, to back an initial Marketing Authorisation Application for to market M6G as a therapy for moderate-to-severe acute post–operative pain in Europe.
In addition, the firm is considering meeting with regulatory authorities in Europe to discuss the drug’s overall clinical development plan in relation to certain label claims which, if successful, would enable the planned profile to show that its use results in less respiratory depression than morphine at equi-analgesic doses. The filing of an Investigational New Drug application in the USA is scheduled for next year.
Commenting on the agent’s potential, Chief Executive Neil Clark said: “Our continuing analysis of the post-operative pain market and the needs of patients and clinicians confirms our view that there is a significant opportunity for CeNeS in realising the clinical and commercial potential of M6G as a novel, safe and effective analgesic with a good side effect profile.”