Salute e Benessere
Camurus announces positive Phase 3 results from the ACROINNOVA 2 study of octreotide SC depot (CAM2029) in acromegaly patients
The primary endpoint was safety over 52 weeks of study treatment. Octreotide SC depot was well tolerated with a long-term safety profile consistent with that of SoC with first generation somatostatin receptor ligands (SRL), extended-release octreotide and lanreotide, with no new safety signals. The most common adverse events (AEs) were mild to moderate injection site reactions and gastrointestinal events. There were no cases of severe AEs related to octreotide SC depot. One patient had a treatment-related serious adverse event of cholelithiasis (moderate), which resolved, and the patient continued treatment in the trial. Two patients (1.5%) discontinued treatment due to AEs; one case of mild depression and once case of mild injection site hemorrhage.
ACROINNOVA 2 included multiple secondary endpoints, including biochemical control rates, symptom scores, and several patient-reported outcomes. Treatment with octreotide SC depot over 52 weeks resulted in significant increases in treatment response rates of 12.7% (95%CI: 5.5%, 19.9%) in the overall population, and 22.8% (95%CI: 11.6, 33.9) in new patients compared SoC at baseline. Roll-over patients, with controlled IGF-1 values at the SoC baseline, maintained or regained (for placebo) biochemical control during treatment with octreotide SC depot. Treatment with octreotide SC depot also resulted in continuous improvement of acromegaly symptom scores and patient reported outcomes, including treatment satisfaction, acromegaly quality of life, and self-injection assessment scores compared to SoC at baseline.
"The results from ACROINNOVA 2 are very encouraging and demonstrated that CAM2029 octreotide SC depot was effective in normalizing IGF-1 levels across patient groups and continuously improving symptoms of acromegaly throughout the 52 weeks of treatment. Additionally, the convenience of a once-monthly SC dosing using the prefilled autoinjector pen contributed to improved treatment satisfaction and quality of life, which are important unmet needs for patients living with acromegaly," says Joanna Spencer-Segal , M.D., Ph.D., Asst. Professor of Internal Medicine, Div. of Metabolism, Endocrinology and Diabetes, University of Michigan, Ann Arbor , Michigan , US, and ACROINNOVA 2 study investigator.
Fredrik Tiberg , President & CEO
Tel. +46 (0)46 286 46 92
fredrik.tiberg@camurus.com
Fredrik Joabsson, Chief Business Development Officer
Tel. +46 (0)70 776 17 37
ir@camurus.com
This information is information that Camurus AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the managing director, at 7:30 am CET on 15 July 2024 .
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View original content: https://www.prnewswire.co.uk/news-releases/camurus-announces-positive-phase-3-results-from-the-acroinnova-2-study-of-octreotide-sc-depot-cam2029-in-acromegaly-patients-302196596.html