The chemistry outsourcing partner will help develop Summit’s antibiotic for Clostridium difficile
Cambridge Major Laboratories Europe (CMLE), a supplier of chemistry services supporting drug development, has been selected by Oxford, UK based drug discovery company Summit Corporation plc (Summit) to provide medicinal chemistry synthesis, perform solid state studies and manufacture cGMP material for use in clinical studies for preclinical development candidate SMT 19969.
Summit recently announced the selection of SMT 19969 as the preclinical development candidate in its programme developing new antibiotics that target infection caused by the hospital superbug Clostridium difficile.
Roger McDonald, European business development director for CMLE said: ‘This is a Wellcome Trust-funded programme and it is important to have a clear, risk-managed focus on delivery to ensure Summit is able to achieve its milestones as quickly as possible. A key aspect of how we manage such first-time scale-up programmes is the ability to perform crystallization and polymorph screens in parallel with process chemistry. This approach is extremely efficient and manages risk very effectively.’
SMT 19969 is currently in formal preclinical development studies, the successful completion of which will enable it to enter human clinical trials. Summit anticipates submitting an application to regulatory authorities to commence clinical trials in Q3 2012.
Operating from FDA inspected facilities in the US and Europe, Cambridge Major Laboratories produces pharmaceutical intermediates and Active Pharmaceutical Ingredients (API), from early preclinical development to commercial manufacture.