This article is more than 5 years old. Information may no longer be current.
Second generation antisense drug trial recruitment completed
Click Here to Manage Email Alerts
A Phase II trial evaluating a second generation antisense drug designed to block growth hormone receptor expression, and thereby reduce levels of the hormone insulin-like growth factor-1 in the blood, has achieved positive results as a potential treatment for diseases including acromegaly.
Antisense Therapeutics Limited announced that 24 patients with acromegaly were recruited into the randomized trial, broken down by two treatment regimens of ATL1103. The open-label, parallel group study investigates the safety, tolerability, pharmacokinetics and efficacy of subcutaneous doses of the drug for 13 weeks with 2 months of follow up. Both regimens give patients 200 mg of ATL1103 three times in the first week, but weekly doses thereafter may be given once (200 mg) or twice (400 mg).
The first round of eight patients to complete the dosing showed a reduction in the serum IGF-1, which is the primary marker of activity in the trial. Reduction of serum IGF-1 to within a normal range in a significant proportion of patients is the goal in Phase III registration trials.
To date, eight more have completed the dosing regimen. There have been no treatment related withdrawals or serious adverse events. The Australian biopharmaceutical drug discovery and development company expects to report the results mid-2014.
For more information: ATL1103 Acromegaly Phase II Trial Recruitment Completed