Camurus announced topline, interim data from an open-label, long-term safety and extension trial, ACROINNova 2, assessing CAM2029, octreotide subcutaneous (SC) depot, in 135 adult patients with acromegaly. These include both new patients and roll-over patients from the previous randomized controlled trial, ACROINNOVA 1, where they received treatment with CAM2029 or placebo ("treatment naive" patients). The Phase 3 data show a favorable safety profile and robust long-term efficacy over 52 weeks of treatment with CAM2029.

Acromegaly is a rare and severe chronic disease caused by a benign pituitary tumor causing excess levels of growth hormone (GH), leading to increased levels of insulin-like growth factor-1 (IGF-1). The disease causes significant morbidity, physical changes, burdensome symptoms, and diminished quality of life of patients. First-line medical treatment of acromegaly is represented by first-generation injectable somatostatin receptor ligands (SRL), octreotide and lanreotide.

Interim topline data from ACROINNOVA 2 show that CAM2029 is well tolerated with a safety profile comparable to current standard of care (SoC) with first-generation SRLs. There were no severe adverse events related to CAM2029. One patient had a related serious adverse event of cholelithiasis, which resolved, and the patient continued in the trial.

Two patients discontinued treatment due to adverse reactions, and one patient had an adverse reaction leading to dose reduction. In addition to a beneficial safety profile, ACROINNOVA 2 shows statistically significant improvements for multiple endpoints from baseline, with SoC and placebo (in treatment naive patients), to the end of study treatment with CAM2029 at week 52. These improvements include: Increased IGF-1 response rate [mean (95% CI) IGF-1<=1xULN] for; Full population from 49.7% to 58.4% with a difference of 8.7% [0.6%, 16.8%), New patients from 12.0% to 30.3% with a difference of 18.3% [6.5%, 30.1%]; Treatment naive patients from 20.2% to 93.8% with a difference of 73.7% [51.5%, 95.8%] CAM2029 patients had stable response rate from 92.8% to 89.4%.