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- The Paediatric Committee (PDCO) of the European Medicines Agency (EMA) has given a positive final opinion on Antisense Therapeutics’ (ANP) Paediatric Investigation Plan
- Provides ANP with confidence to conduct a phase 2b/three trial in Europe, testing the efficacy and safety of ATL1102 for patients with Duchenne muscular dystrophy
- To support the planned trial, ANP is looking to raise up to nearly $37 million through a placement which it has received commitments for and subsequent entitlement offer
- Company shares are down 18.6 per cent to trade at 24 cents
The Paediatric Committee (PDCO) of the European Medicines Agency (EMA) has given a positive final opinion on Antisense Therapeutics’ (ANP) Paediatric Investigation Plan.
The plan addresses the entire paediatric development program for the company’s ATL1102 drug candidate in Duchenne muscular dystrophy (DMD).
Receiving a positive final opinion from PDCO ensures planned clinical studies of ATL1102 in DMD-afflicted boys in Europe will be run in accordance with the PDCO’s expectations for future product approval.
Managing Director Mark Diamond said the feedback “provides us with great confidence to undertake our phase 2b/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 phase 2b and three trial is a randomised, double-blind, placebo-controlled study to
determine the efficacy, safety, and pharmacokinetic profile of ATL1102, which will be administered once per week for 52 weeks in non-ambulatory participants with DMD. The trial may be followed up with an open label extension trial.
Antisense has appointed clinical research organisation Parexel to conduct and manage the trial. Parexel is currently finalising site evaluations to select up to 30 sites across Europe. Once the requisite clinical trial approvals are received for each jurisdiction, patient recruitment will begin.
To fund the trial, potential extension trial, ongoing research and development, and working capital, the company has launched a placement and entitlement offer.
The company has received firm commitments for an oversubscribed institutional placement to raise $20 million through the issue of approximately 83.3 million new shares at 24 cents each. The issue price marks an 18.6 per cent discount to the last closing price on October 27.
New shares are expected to settle on November 4 and are expected to be allocated and commence trading on the following day.
Following the placement, ANP will undertake a non-underwritten one-for-9.4 entitlement
offer which aims to raise $16.8 million at the same price as the placement.
Participants in the placement and the entitlement offer will also be offered one free-attaching option, each exercisable at 48 cents for every two new shares subscribed for.
Company shares were down 18.6 per cent to trade at 24 cents at 12:58 pm AEDT.
