Antisense Therapeutics (ASX:ANP) has provided an update on its agreement with early access provider myTomorrows to implement an ATL1103 Early Access Program (EAP) for the treatment of acromegaly patients within select countries of the European Union.
Labelled and packaged ATL1103 drug product is currently being stored in the United Kingdom for shipment to myTomorrows in the Netherlands for potential EAP distribution, said the company in a statement.
However, it also said it has to date been unable to obtain myTomorrows’ clearance for importation.
Antisense said further to myTomorrows' requests, it has generated additional product data and documentation in order for the ATL1103 drug product to be supplied in accordance with the required regulatory and quality standards.
"Following a review by an external Quality Person (QP), requested by myTomorrows, of the manufacturing documentation including this newly generated data, the QP advised that due to the ATL1103 material intended for use in the EAP being supplied by a different manufacturer to the one used for the manufacture of material previously used in the Phase II clinical trial of ATL1103, it would first need to be approved by a European Health authority for use in a new clinical trial, for the material to be cleared for the EAP," it said.
The company said it had not expected this clinical trial approval prerequisite for ATL1103 EAP initiation.
"A new clinical trial would require a substantial financial commitment from the Company to proceed with the next phase of clinical development for ATL1103," it continued, adding it will not apply further resources to the EAP process but continue to direct its focus and funds on the ATL1102 trial for Duchenne muscular dystrophy.
Antisense said it is still exploring opportunities to provide ATL1103 drug product to experts to generate supportive clinical data for its use in acromegaly.
"ANP is also continuing to pursue the potential out-licensing of ATL1103 to support and fund its ongoing clinical development and is presently entertaining preliminary interest from some regionally based pharmaceutical companies," it said.