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 naïve' 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.1-3 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 naïve 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 naïve 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%. Reduced acromegaly symptom burden during treatment with CAM2029 as measured by proportion of patients with any acromegaly symptom and the Acromegaly Index of Severity (AIS) score (sum of scores of the six acromegaly symptoms of headache, sweating, fatigue, joint pain, paresthesia, and soft tissue swelling).

Increased patient and treatment satisfaction as measured by the Patient Satisfaction score and Treatment Satisfaction Questionnaire for Medication (TSQM) scores. Improved quality of life as measured by the Acromegaly Quality of Life Questionnaire (AcroQoL) scores and the EuroQoL 5D-5L VAS. The interim results of ACROINNOVA 2 will be part of the regulatory submissions for CAM2029 and presented at upcoming medical meetings and in a scientific publication.

About the ACROINNOVA clinical program: ACROINNOVA comprises two Phase 3 studies evaluating efficacy and safety of octreotide SC depot (CAM2029). The first trial (ACROINNOVA 1, NCT04076462) is a 24-week, randomized, double-blind, multi-center, placebo-controlled Phase 3 trial that randomized 72 adult patients with acromegaly, who were on stable treatment with octreotide LAR4 or lanreotide ATG at enrollment. Topline results from ACROINNOVA 1 were announced on 20 June, 2023.

Additionally, Camurus is conducting an open-label, Phase 3 long-term safety and extension trial of octreotide SC depot (ACROINNOVA 2, NCT04125836). 81 new participants have been enrolled in the trial and 54 patients have rolled over from ACROINNOVA 1 from 24 weeks treatment with CAM2029 or placebo (treatment naïve patients) to the extension part of the trial. Complete results from the 52 weeks treatment period are expected in Second Quarter 2024.

The study has been extended with an additional year of treatment and is expected to continue until 2025. About acromegaly and octreotide subcutaneous (SC) depot (CAM2029): Acromegaly is a rare, slowly progressive, and serious condition typically caused by a tumor of the pituitary gland, resulting in overproduction of growth hormone and insulin growth factor 1. This may cause physiological changes, disease symptoms, diminished quality of life, and, if untreated, premature death. The prevalence of acromegaly is estimated at about 60 cases per million.