Antisense Therapeutics (ASX:ANP) has provided a progress update on the manufacture of clinical supplies for its planned Phase IIb clinical trial of ATL1102 in non-ambulant Duchenne (DMD) patients.
The company said the manufacture of ATL1102 active pharmaceutical ingredient (API) for the Phase IIb trial was undertaken in North America by Nitto Denko Avecia (Avecia). Avecia is a contract manufacturing organization (CMO) with over 27 years of experience in oligonucleotide (antisense) development and production.
Antisense said Avecia has supported the commercial launch of oligonucleotide products since 2004 and offers complete continuity of supply up to multiple kilograms per batch with its large scale and commercial capabilities in support of advanced clinical trials and subsequent commercial supply.
Upon completion of the manufacture of this batch of API by Avecia last month, the material was then shipped to Contract, Parenteral (injectable) Drug Product Manufacturer Pyramid Laboratories in Costa Messa, Southern California. It was then formulated into injectable product for use in the Phase IIb trial.
The company said this formulated injectable product (Drug Product or DP) is currently undergoing finished product release testing for clinical use, with results anticipated later next month.
Antisense CEO Mark Diamond CEO said, “We are very pleased with how the manufacture of clinical supplies for our planned Phase IIb trial of ATL1102 has proceeded particularly given the challenges that have presented to all CMO’s during the global covid pandemic.
"We are indeed fortunate to be partnered with such high-quality CMOs that have a deep experience with antisense drugs and both of which we have been working with for over 15 years and that can support manufacture all the way through to commercial sale of product”.