Antisense Therapeutics reported that 24 acromegalic patients have been successfully enrolled and randomized to one of the two treatment regimens of dosing in the Phase II trial of ATL1103 for the growth disorder, acromegaly (Press release Antisense Therapeutics, MAR 21, 2014, View Source [SID:1234501494]). This satisfies the necessary patient numbers proposed for the trial.
Following from the positive results achieved from the interim analysis of the serum Insulin-like Growth Factor-I (sIGF-I) data from the 8 patients who had completed the full 13 weeks of dosing in the trial, a further 8 (16 in total) have now completed dosing. Notably to date no patients dosed with ATL1103 have withdrawn from the study nor have there been any reports of serious adverse events identified as treatment related.
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With patient enrollment now complete, ANP anticipates reporting the results of the statistical analysis of the sIGF-I data from all patients by mid 2014. Reducing sIGF-I levels is the primary marker of ATL1103 activity in this trial as acromegaly patients have elevated sIGF-I levels compared to the normal population, and reduction of sIGF-I to within a normal range in a significant proportion of patients is the goal in Phase III registration trials for acromegaly treatments.
Mark Diamond, Managing Director and CEO of Antisense Therapeutics said "Completion of patient recruitment into a clinical trial is a major milestone and especially in the case of trials involving patients with a rare or orphan status disease such as acromegaly and so we are very pleased to report this significant achievement. We now look forward to completing the dosing in all patients and to the reporting of the results."
ATL1103 Phase II trial is a randomised, open-label, parallel group study of the safety, tolerability, pharmacokinetics and efficacy of two subcutaneous dosing regimens of ATL1103 in 24 adult patients with acromegaly dosed with ATL1103 for 13 weeks (3 months) with two months of follow up. Two ATL1103 dosing regimens are being tested (a) 200 mg 3 times in the first week then once weekly thereafter (200 mg/week) or (b) 200 mg 3 times in the first week then twice weekly thereafter (400 mg/week). The primary endpoints or main purposes of the trial as listed on the trial protocol are (i) to evaluate the safety and tolerability of ATL1103 in patients with acromegaly, and (ii) to evaluate the single dose and multiple dose pharmacokinetic profiles of ATL1103 via the subcutaneous route in patients with acromegaly. A secondary, but important endpoint that is also on the trial protocol is the evaluation of ATL1103’s effect on serum insulin like growth factor I (IGF-I) levels in patients. The secondary endpoint is the average percentage reduction in serum IGF-I levels at the end of treatment compared to baseline levels for each of the two dosing regimens used in the Phase II study.