Antisense Therapeutics (ASX:ANP) has announced the higher dose clinical trial of ATL1103 in acromegaly patients is closed.
The last patient’s last clinic visit was in late September 2016. The final data is being compiled and a clinical study report is in preparation, said the company in a statement.
The higher dose study was an open-label study of the safety, tolerability, pharmacokinetics and efficacy in acromegaly patients. The primary efficacy endpoint of the trial was the reduction of serum Insulin like Growth Factor I (sIGF-I) levels in acromegaly patients as they have significantly higher levels than healthy individuals and sIGF-I normalisation is accepted by authorities as the therapeutic goal for the treatment of acromegaly.
Three patients were enrolled in the study and dosed with ATL1103 at 300 mg twice weekly (2 patients), capped at a weekly dose of 6 mg/kg (1 patient). All 3 patients were dosed for 13 weeks, with one patient at the request of the Principal Investigator receiving an extended dosing period of an additional 12 weeks. There was a follow-up period of 2 months for all patients.
"Positive results of an interim analysis of the data from the study were reported by the Company on 27th July 2016," said the company. "At that time two patients had completed the study and one patient was still being dosed in the extended dosing period. The interim analysis confirmed that the drug appeared effective and safe at the doses tested with normalisation of IGF-I in one patient and therapeutically relevant reductions in two patients.
"Now that the 3rd patient has completed the study the Company can confirm that the patient’s IGF-I level was normalised during the extended dosing period. Maximal suppression of IGF-I in that patient was 44% from baseline at week 26 (vs 33% at week 13). This is higher than the mean reduction reported in the interim analysis (26.7% at week 13 and 18.6% at week 14) and is consistent with ATL1103 dose modelling predictions that greater effects are achievable with longer ATL1103 dosing regimens."
Mark Diamond, CEO of Antisense Therapeutics, said: ”While it was a small study, it is most pleasing to report on the very encouraging efficacy and safety profile of ATL1103 demonstrated in this higher dose trial. All 3 patients received a therapeutic benefit from the drug and 2 of the 3 patients achieved the goal of sIGF-I normalisation including the patient administered with ATL1103 for an extended dosing period of 6 months whose disease had not been controlled on their prior acromegaly medications. The clinical experience gained from this trial will be important in the continued development and commercialisation of ATL1103 for acromegaly.”