Camurus reports positive Phase 3 results for CAM2029 in acromegaly

In a significant development, Camurus (NASDAQ: CAMX) (STO: CAMX) has announced the positive final topline results of its 52-week Phase 3 ACROINNOVA 2 study (NCT04125836). This open-label study assessed the safety and efficacy of the company's once-monthly octreotide subcutaneous (SC) depot (CAM2029) in treating acromegaly. The trial included 135 patients, both those biochemically controlled and uncontrolled on stable doses of standard-of-care (SoC) with first-generation somatostatin ligands (SRL). Out of these, 81 were new participants, and 54 were roll-over patients from the previous 24-week randomized ACROINNOVA 1 study involving octreotide SC depot or placebo.

Fredrik Tiberg, President & CEO, and CSO of Camurus, stated, "The ACROINNOVA 2 results underscore the long-term safety and efficacy of octreotide SC depot in managing acromegaly. These findings further solidify the potential of CAM2029 as a new therapeutic option pending approval. Regulatory reviews are ongoing in the US and EU, with the US FDA expected to make a decision by October 21, 2024."

The study's primary endpoint was to evaluate safety over the 52-week treatment period. Octreotide SC depot was well tolerated, showing a safety profile consistent with existing treatments, such as extended-release octreotide and lanreotide, without new safety concerns. Common adverse events (AEs) included mild to moderate injection site reactions and gastrointestinal issues. There were no severe AEs attributed to the treatment. One patient experienced a moderate treatment-related serious adverse event (cholelithiasis), which resolved, allowing the patient to continue treatment. Only two patients (1.5%) discontinued the treatment due to AEs, one due to mild depression and another due to mild injection site hemorrhage.

The study also looked at several secondary endpoints, such as biochemical control rates, symptom scores, and patient-reported outcomes. Treatment with octreotide SC depot over 52 weeks resulted in a significant increase in treatment response rates by 12.7% in the overall population and 22.8% in new patients compared to SoC at baseline. Patients who had rolled over from the previous study maintained or regained biochemical control. Additionally, treatment led to continuous improvement in acromegaly symptom scores, treatment satisfaction, quality of life, and self-injection assessment scores compared to baseline.

Dr. Joanna Spencer-Segal, a study investigator and Assistant Professor of Internal Medicine at the University of Michigan, commented, "The results from ACROINNOVA 2 are very promising. CAM2029 octreotide SC depot effectively normalizes IGF-1 levels and improves acromegaly symptoms over the 52-week period. The convenience of a once-monthly SC dosing with a prefilled autoinjector pen significantly enhances treatment satisfaction and quality of life, addressing important unmet needs for acromegaly patients."

Acromegaly is a rare, progressive disorder often caused by a pituitary gland tumor leading to excessive growth hormone production and elevated insulin growth factor-1 (IGF-1) levels. This results in abnormal growth of bones and tissues, enlarged extremities and facial features, and various symptoms such as fatigue, joint pain, headaches, visual defects, excessive sweating, and paresthesia. Poor biochemical and symptom control can severely impact the quality of life and increase mortality risks for acromegaly patients. The condition's prevalence is estimated at about 60 cases per million.

The ACROINNOVA clinical program includes two Phase 3 trials assessing the efficacy and safety of CAM2029. The first was a 24-week randomized, double-blind, placebo-controlled study involving 72 patients. The second is the 52-week extension trial involving 135 participants. Interim results from ACROINNOVA 2 were previously released in July 2023, with the study expected to continue until 2025.

CAM2029 is an investigational, ready-to-use octreotide designed for subcutaneous administration, aimed at treating acromegaly, gastroentero-pancreatic neuroendocrine tumors (GEP-NET), and polycystic liver disease (PLD). The drug offers enhanced octreotide exposure with convenient once-monthly administration using a prefilled autoinjector pen. The CAM2029 clinical program comprises seven trials, demonstrating superior biochemical control and improvements in symptom management, treatment satisfaction, and quality of life compared to baseline SoC treatments. The safety profile of CAM2029 aligns with existing treatments without new adverse findings.

Camurus is a science-driven biopharmaceutical company from Sweden, focusing on developing long-acting medications for severe and chronic conditions, leveraging its proprietary FluidCrystal® drug delivery technologies. The company's clinical pipeline includes treatments for dependency, pain, cancer, and endocrine diseases, developed both in-house and in collaboration with global pharmaceutical partners.