- Antisense Therapeutics (ANP) has released the results from a phase two clinical trial of its ATL1102 drug for Duchenne Muscular Dystrophy (DMD)
- The primary endpoints of the trial were met, confirming the drug’s safety and tolerability
- Secondary endpoints related to ATL1102’s activity and efficacy were also surpassed
- The company will now move towards a phase 2b clinical trial in Europe and the U.K., and will look to gain a deeper understanding of the drug’s effects
- Antisense Therapeutics is up a substantial 50 per cent today, trading for 7 .2 cents per share
Antisense Therapeutics (ANP) has released the results from a phase two clinical trial of its ATL1102 drug for Duchenne Muscular Dystrophy (DMD).
Over the course of the six-month trial, 25mg of ATL1102 was administered to nine patients with DMD, aged between 10 and 18 years, every week. It was conducted at the neuromuscular centre of the Royal Children’s Hospital in Melbourne.
With the trial now complete, ATL1102 was shown to successfully meet its primary endpoint related to the safety and tolerability of the drug. No serious adverse effects were reported, and there were no concerns raised by the Data Safety Monitoring Board.
However, some cases of mild erythema and skin discolouration were reported at the injection site of the drug. This was regarded only as a mild side effect, and the cases were either fully or largely resolved by the end of the monitoring period.
In addition, secondary endpoints related to ATL1102’s activity and efficacy were also surpassed. This data measured the effect of the drug on immune cell numbers in the blood and evaluated changes in the participant’s functional capacity, including grip and pinch strength.
With such positive results to date, Antisense Therapeutics will now submit a clinical trial application for a phase 2b trial in Europe and the U.K. Further to this, a submission is currently in progress for Orphan Drug Designation for ATL1102’s use in DMD in the United States and the European Union.
With these tasks underway, the company will conduct additional laboratory analyses in order to gain a deeper understanding of the drug’s effects.
Mark Diamond, CEO of Antisense Therapeutics, said that the company’s current primary focus is on moving towards the phase 2b trial.
“As we gain further certainty from the regulatory process on the parameters of the next trial, which may lead to early market approval, we will assess funding and trial management options and also engage in discussions with interested potential partners ahead of the commencement of phase 2b.
“This will allow the Company to consider the most advantageous way to proceed with the pivotal trial on its own or with a partner. Potential partners’ input into the trial program may also be beneficial for future commercialisation plans,” he added.
Antisense Therapeutics is up a substantial 50 per cent today, trading for 7 .2 cents per share at 12:23 pm AEST.