Involvement started when the chemistry was initially transferred, through to scale-up and production of pre-clinical material, and subsequent GMP manufacture
Ultrafine has successfully completed the manufacture of Aryx Therapeutics's lead compound, ATI 2042, to GMP.
ATI 2042, which entered Phase 1 clinical trials in Q4 2003, is currently being evaluated for its safety and efficacy in chronic antiarrhythmic therapy.
UFC's involvement in the project started when the chemistry was initially transferred from Aryx, through to scale-up and production of pre-clinical material, and subsequent GMP manufacture.
Pascal Druzgala, chief scientific officer for Aryx, commented: "Ultrafine's contributions to the ATI-2042 project have proved invaluable at each stage of the development process and have helped ensure that Aryx has been able to maintain a very tight preclinical timeline. "Ultrafine has been particulary helpful in working with us as an early stage company as we face the dual challenge of process improvement and cost effective spending".
Mike Harris, Ultrafine's head of business development, added: "ATI 2042 exhibited excellent qualities throughout pre-clinical evaluation and we are delighted to have been able to demonstrate our capabilities at each step of its evolution, from technology transfer, through process development, and GMP manufacture."
