Camurus (STO: CAMX), a commercial stage biopharmaceutical company specialising in long-acting medicines for severe and chronic disorders, announced on Thursday that the US Food and Drug Administration (FDA) has accepted an Investigational New Drug (IND) application to initiate a phase 3 study with CAM2029 once-monthly octreotide subcutaneous depot for treatment of acromegaly.

According to the company, with the receipt of this IND approval, it will now proceed to start the pivotal phase 3 study of CAM2029 octreotide subcutaneous depot for the treatment of acromegaly.

This phase 3 trial is a randomised, double-blind, placebo-controlled, multinational, multi-centre study in patients with acromegaly and previously treated with long-acting somatostatin analogues. Patients will be treated with CAM2029 or placebo for 24 weeks, and the primary efficacy measure is biochemical response, as measured by insulin growth hormone-1 (IGF-1) levels.

This study will be performed at around 50 clinical sites in the US and in Europe and is expected to be completed early 2021.

CAM2029 has been granted orphan designation by the European Commission for acromegaly.