Antisense Therapeutics (ASX:ANP) has announced positive news from the Paediatric Committee (PDCO) of the European Medicines Agency (EMA) and the successful completion of a successful capital raise.
The company said PDCO has adopted a positive final opinion on its Paediatric Investigation Plan (PIP) for the development of ATL1102 for Duchenne muscular dystrophy (DMD).
A PIP is a development plan aimed at ensuring that the necessary data is obtained through studies in children. Approval of the PIP is required to support the authorisation of a medicine for children in the European Union.
The PIP addresses the entire paediatric development program for ATL1102 in DMD.
The company said the positive final opinion ensures that its planned clinical studies including its Phase IIb/III clinical trial of ATL1102 in non-ambulant DMD boys in Europe, will be run in accordance with PDCO expectations for future product approval.
Antisense said it has also received firm commitments in an oversubscribed institutional placement to raise $20 million via an issue of approximately 83.3 million new fully paid ordinary shares at $0.24 per share.
It said the placement was strongly supported by existing shareholders and that it has also welcomed a number of new institutional investors to the share register.
The company also intends to conduct a non-underwritten 1 for 9.4 entitlement offer targeting to raise $16.8 million at the same price as the placement.
Managing director Mark Diamond said, “We are both pleased and extremely proud to have received this positive Opinion from PDCO on our PIP for ATL1102 in DMD which provides us with great confidence to undertake our Phase IIb/III trial in DMD in a manner consistent with the expectations of the regulator and which if successfully completed, could bring us an approval to market ATL1102 for the treatment of DMD in Europe, the world’s second largest pharmaceutical market.
"The achievement of this major clinical development milestone has allowed us to move forward with the successful financing also announced today. The capital raising itself represents a pivotal moment in the history of the Company in providing a potential funding pathway for the conduct of the Phase IIb/III clinical trial through to trial results and in doing so gets us closer to bringing a much-needed therapy to patients in desperate need of better treatments. Accordingly, we would like to thank our existing shareholders and welcome all new investors who participated in the placement for supporting our development efforts.
With only a small number of ASX listed companies having made the journey into Phase III clinical development we know that we are in rarified pharmaceutical company. We appreciate the challenges that may lay ahead, though our highly experienced board and management team are very excited and energized to be embarking on this final stage of clinical development for treatment of non-ambulant DMD, a momentous occasion in the history of ANP, and we hope also in the lives of boys with DMD.”
