- Antisense Therapeutics (ANP) applies for the lifting of a partial clinical hold that limits dosing of its muscular dystrophy drug
- After positive feedback from a US Phase IIb/III study, ANP lodged a FastTrack Designation (FTD) request to the US Food and Drug Administration (FDA)
- The FDA was encouraging of ANP’s work, but clarified that a partial clinical hold limiting dosing would need to be lifted before the FTD could be granted
- The company is working with advisors to submit its complete response and says it will continue to update the market on its US regulatory planning
- Shares have been trading 10 per cent lower at 18 cents apiece at 11:23 am AEST
Antisense Therapeutics (ANP) is applying for the lifting of a partial clinical hold that limits dosing of its muscular dystrophy drug.
The Company is developing ATL1102 for Duchenne muscular dystrophy (DMD) patients and was recently encouraged by Phase II trial results.
After receiving “positive feedback” on the design parameters for a US Phase IIb/III study, ANP submitted a FastTrack Designation Request (FTD) to the US Food and Drug Administration (FDA).
The company outlined in the FTD its intent to submit a revised clinical study protocol, with design features as discussed with the FDA during a Type C meeting, including higher and longer dosing.
ANP also expects to submit the protocol synopsis for a nine-month chronic monkey toxicology study to support the dosing of patients beyond 6 months.
However, the FDA has responded to let ANP know there is an Investigational New Drug partial clinical hold that limits the dosing of ATL1102 to 25 miligrams per week for 6 months.
The regulatory body noted in its response that “DMD is certainly a serious condition, and it appears that ATL1102 may have the potential to demonstrate an effect on a serious aspect of the condition and provide benefit over currently approved therapies.”
It went on to say it could not determine whether the overall development plan will enable the company to obtain the data necessary to evaluate whether the product meets this unmet medical need due to the limiting hold.
Before the FTD can be granted, the company will need to complete the regulatory process for lifting the hold.
Specifically, ANP said the process involves including the requisite documentation, which is updated clinical and toxicology protocols, in a resubmission as suggested by the FDA.
The Company said it has been working with its advisors on the submission of its complete response and will continue to update the market on material progress in its US regulatory planning.
ANP’s Chair, Dr Charmaine Gittleson said lifting the partial hold would facilitate the drug becoming active and would potentially allow patients in the USA to access it through a clinical program, as well as clear the path for FDA consideration of the FTD submission.
Shares have been trading 10 per cent lower at 18 cents apiece at 11:23 am AEST.