Antisense Therapeutics Ltd. reported the primary efficacy results from its Phase 2 clinical trial of ATL1103 in patients with the potentially life threatening growth disorder, acromegaly. The Phase 2 trial met its primary efficacy endpoint showing a statistically significant average reduction in the serum insulin-like growth factor-I (sIGF-I) levels of 26% from baseline (p<0.0001) at week 14 (one week past the last dose) at the 400mg per week dose tested.
All patients treated with 400mg per week of ATL1103 had a reduction in sIGF-I levels from baseline at week 14. Greater reductions in sIGF-I were observed in patients who had lower body weights and thereby received a relatively higher dose per kg bodyweight (correlation of p=0.0001) with the patients who received >5.5 mg/kg per week showing a 36% average reduction in their sIGF-I levels.
The positive results achieved in this Phase 2 trial position ATL1103 to move into Phase 3 stage of development. Consequently, ANP will accelerate out-licensing activities to secure a pharmaceutical development partner for the drug’s further development.
Chief Investigator for the study, Dr. Peter Trainer, professor of endocrinology, The Christie NHS Foundation Trust, UK, said: “There are limited therapeutic options for patients with acromegaly and there is an acknowledged need for new therapies. The results achieved in this Phase 2 trial suggest ATL1103 with appropriate dose adjustment should be capable of achieving disease control in a significant proportion of patients with acromegaly. ATL1103’s profile as a potentially efficacious and well tolerated conveniently dosed therapy strongly supports its move into Phase 3 stage of development.”
Mark Diamond, managing director and CEO of Antisense Therapeutics said: “We are very pleased to have achieved this significant milestone in the late stage development of ATL1103. These results greatly enhance our partnering prospects for the drug and we expect a number of interested pharmaceutical companies to enter formal due diligence on ATL1103 in coming months.”
Date: September 3, 2014
Source: Antisense Therapeutics