Camurus announced positive topline results from a 24-week Phase 3, randomized, double-blind, placebo-controlled trial, ACROINNOVA 1, evaluating the efficacy and safety of the company's octreotide subcutaneous (SC) depot (CAM2029) in adults with acromegaly. The product is designed for convenient, once-monthly administration with ready-to-use syringe or injection pen to facilitate easy administration by patients. ACROINNOVA 1 enrolled 72 patients on stable treatment with standard of care (SoC) with octreotide LAR1 or lanreotide ATG2, who were randomized in a 2:1 ratio to treatment with octreotide SC depot or placebo.

The trial met both the primary and the keysecondary endpoints with statistical significance, including all sensitivity and supportive analyses. Acromegaly is a rare and chronic disease caused by a benign pituitary tumor resulting in overproduction of growth hormone (GH) and excess insulin-like growth factor (IGF-1). Together, this leads to abnormal growth of tissue and bone, causing enlargement of hands, feet and facial features, and a range of disease symptoms such as fatigue, joint pain, muscle weakness, weight gain, sleep apnea, headache, and excessive sweating and paresthesia.3 Patients with acromegaly have reduced quality of life and often report high treatment burden.

Key topline findings of the trial are summarized below for the intention-to-treat population: Superior IGF-1 response rate (primary endpoint) of 72.2% in patients treated with octreotide SC depot versus 37.5% in patients treated with placebo (mean IGF-1=upper limit of normal (ULN) week 22 and 24); p=0.0018, Superior IGF-1 and GH response rate (key secondary endpoint) of 70.0% in patients treated with octreotide SC depot versus 37.5% in patients treated with placebo (mean IGF-1=ULN week 22 and week 24, and GH <2.5 µg/L week 24); p=0.0035, All sensitivity and supportive analyses confirmed the main findings. The response rate in the per protocol population was 81.0% for octreotide SC depot vs. 38.1% for placebo; p=0.0002, Median time to loss of response (IGF-1>ULN) was not reached for patients treated with octreotide SC depot and was 8.4 weeks for placebo; p<0.0001, IGF-1 was well controlled until the end of the trial with a significant treatment difference versus placebo; p=0.0004, Increased quality of life (AcroQoLTotal score) indicated from baseline to week 24 for octreotide SC depot vs.

SoC; p=0.0038. Significant increases were seen for all AcroQoL domains for octreotide SC depot, Increased treatment satisfaction (incl. TSQM convenience score) from baseline to week 24 for octreotide SC depot vs.

SoC; p<0.0001. The promising data obtained for patienttreatment satisfaction, symptom control and quality of life will be expanded by data from the ongoing Phase 3 long-term safety extension study of octreotide SC depot, ACROINNOVA 2.