Pharma Focus Europe

Camurus Announces Phase 3 Trial Findings Supporting the Long-term Safety and Efficacy of Octreotide Sc Depot (CAM2029) in Acromegaly Patients

Monday, July 17, 2023

Camurus, a company listed on NASDAQ STO under the ticker symbol CAMX, has recently shared interim topline data from a clinical trial called ACROINNOVA 2. The trial evaluated the long-term safety and efficacy of CAM2029, an octreotide subcutaneous (SC) depot, in 135 adult patients with acromegaly. The study included both new patients and those who had previously participated in a randomized controlled trial called ACROINNOVA 1. The Phase 3 data revealed a favorable safety profile and strong long-term efficacy of CAM2029 over a 52-week treatment period.

According to Fredrik Tiberg, the President & CEO and CSO of Camurus, the Phase 3 data from ACROINNOVA 2 is encouraging, showing improved control of biochemical markers and symptoms compared to the standard of care. Additionally, the data indicated an improvement in the quality of life of patients, further supporting the potential of CAM2029 as a new treatment option for acromegaly.

Acromegaly is a rare and serious chronic disease caused by a benign pituitary tumor, resulting in excessive production of growth hormone and increased levels of insulin-like growth factor-1. This condition leads to various physical changes, burdensome symptoms, and reduced quality of life for patients. The current first-line medical treatment for acromegaly involves the use of injectable somatostatin receptor ligands (SRLs) such as octreotide and lanreotide.

The interim topline data from ACROINNOVA 2 demonstrated that CAM2029 was well-tolerated and had a safety profile comparable to the current standard of care with first-generation SRLs. There were no severe adverse events related to CAM2029, except for one patient who experienced cholelithiasis, which was resolved, allowing the patient to continue in the trial. Only two patients discontinued treatment due to adverse reactions, and one patient had an adverse reaction leading to a dose reduction.

Apart from its favorable safety profile, ACROINNOVA 2 showed statistically significant improvements in multiple endpoints compared to baseline and placebo at the end of the 52-week treatment period with CAM2029. These improvements included an increased IGF-1 response rate, reduced acromegaly symptom burden, increased patient and treatment satisfaction, and improved quality of life.

Prof. Diego Ferone, an endocrinologist and the coordinating investigator in the trial, emphasized the impressive nature of the ACROINNOVA 2 data. He stated that CAM2029 has the potential to address key unmet medical needs of acromegaly patients, including improving biochemical control, symptoms, and quality of life. Furthermore, high patient satisfaction was observed due to the convenience of the prefilled pen and syringe, allowing for easy self-administration.

The interim results from ACROINNOVA 2 will be included in regulatory submissions for CAM2029 and presented at upcoming medical meetings and in scientific publications.

The ACROINNOVA clinical program consists of two Phase 3 studies: ACROINNOVA 1 and ACROINNOVA 2. ACROINNOVA 1 was a 24-week, randomized, double-blind, placebo-controlled trial involving acromegaly patients who were already receiving stable treatment with octreotide LAR or lanreotide ATG. ACROINNOVA 2 is an open-label, long-term safety and extension trial, with new participants and patients rolling over from ACROINNOVA 1. Complete results from the 52-week treatment period of ACROINNOVA 2 are expected in Q2 2024, with the trial projected to continue until 2025.

CAM2029 is an octreotide SC depot developed for the treatment of acromegaly, as well as gastroenteropancreatic neuroendocrine tumors and polycystic liver disease. It offers the convenience of once-monthly administration using an injection pen, potentially improving efficacy, convenience, and quality of life compared to current treatments. CAM2029 has undergone five completed Phase 1 and 2 studies, demonstrating increased plasma exposure compared to octreotide LAR 4.

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