Antisense Therapeutics (ASX:ANP) has announced that dosing has commenced in its ATL1103 higher dose study with two patients (of the planned 4) having received their initial dose of ATL1103 at one of the Australian clinical trial sites.
The ATL1103 higher dose trial is an open-label study of the safety, tolerability, pharmacokinetics and efficacy of ATL1103 in 4 adult patients with acromegaly dosed with ATL1103 up to 300mg twice weekly for 13 weeks.
Dosing of these patients will be completed before the end of the year, the company said.
According to Antisense, the timing of the reporting of results from the study will depend on the enrolment and the medication status of the additional patients required to complete the trial as patients recruited for this study are screened to confirm eligibility during a 28 day period and may need to 'washout' any current acromegaly medications for a period of 6 weeks to 4 months, depending on the type of medication, before dosing with ATL1103 may begin.
Antisense said the ATL1103 higher dose study will run in parallel with other activities to be conducted by its licensing partner, Strongbridge Biopharma.
These activities include seeking orphan drug designation from the FDA and the EMA, the conduct of Phase 3 enabling chronic toxicology studies and a pre-IND meeting with the FDA in the second half of 2015 to discuss requirements for entry into Phase 3 clinical development.
The costs associated with the higher dose study will be reimbursed by Strongbridge Biopharma as part of the ATL1103 licensing agreement announced in May 2015.
Strongbridge Biopharma are responsible for the ongoing clinical development of ATL1103 in endocrinology applications and will fund the associated future development, regulatory and drug manufacture costs.