Camurus announces positive Phase 3 results from the ACROINNOVA 2 study of octreotide SC depot (CAM2029) in acromegaly patients

Rhea-AI Summary

Camurus (NASDAQ: CAMX) announced positive final results from the 52-week Phase 3 ACROINNOVA 2 study of octreotide SC depot (CAM2029) in acromegaly patients. The study met its primary safety endpoint, showing a profile consistent with standard-of-care. Key findings include:

1. Increased biochemical response rates vs. baseline
2. Continuous improvement in acromegaly symptoms and quality of life
3. Well-tolerated treatment with no new safety signals

The study included 135 patients, with 81 new and 54 roll-over patients. Results showed a 12.7% increase in treatment response rates overall, and 22.8% in new patients. Regulatory reviews are ongoing in the US and EU, with an FDA decision expected by October 21, 2024.

Positive

• Phase 3 ACROINNOVA 2 study met its primary safety endpoint
• Increased biochemical response rates of 12.7% overall and 22.8% in new patients
• Continuous improvement in acromegaly symptoms and quality of life scores
• Well-tolerated treatment with safety profile consistent with standard-of-care
• Regulatory reviews ongoing in US and EU with potential FDA approval by October 21, 2024

Negative

• Two patients (1.5%) discontinued treatment due to adverse events

Financial Analyst

The positive results from the ACROINNOVA 2 study present significant implications for Camurus. This Phase 3 study data demonstrates the potential for CAM2029 to offer a new treatment option for acromegaly patients, potentially leading to approval by regulatory bodies such as the FDA and EMA. From a financial perspective, this could translate into substantial future revenue streams if the approval is granted and the product is successfully commercialized.

Key financial considerations:

• Revenue Potential: Effective treatments for rare diseases like acromegaly often command premium pricing due to the lack of alternatives, positioning CAM2029 to generate considerable revenue upon approval.
• Market Expansion: Success in acromegaly could open doors to the application of CAM2029 for other indications, further broadening Camurus' market potential.
• Cash Flow Impact: While regulatory reviews and potential approval processes entail costs, the long-term benefit in terms of revenue could outweigh these initial expenditures.

Investors should monitor regulatory developments closely as approval announcements can significantly impact stock prices.

Medical Research Analyst

The ACROINNOVA 2 study results are quite significant from a clinical and research perspective. The demonstrated efficacy and safety profile of CAM2029 enhance its standing as a preferred treatment for acromegaly. Notably, the 52-week data showing maintained or regained biochemical control in roll-over patients and significant improvement in treatment response rates in the overall population, highlight the drug's potential superiority over existing standard-of-care treatments.

Key clinical insights:

• Improved Biochemical Response: A 12.7% increase in treatment response rates is noteworthy as it indicates better management of IGF-1 levels, important in controlling acromegaly symptoms.
• Patient Quality of Life: Continuous improvement in patient-reported outcomes suggests a tangible improvement in the daily lives of patients, addressing an important unmet need.
• Convenience: The once-monthly SC dosing using an autoinjector pen contributes to treatment adherence and satisfaction, reducing the treatment burden on patients.

These factors make CAM2029 a compelling candidate in the acromegaly treatment landscape, potentially influencing clinical practice guidelines and patient management strategies.

• Treatment well tolerated with a safety profile consistent with standard-of-care (SoC)
• Increased biochemical response rates (IGF-1≤1xULN) vs SoC at baseline
• Continuous improvement of acromegaly symptom and quality of life scores vs baseline
• Study results reinforce previously reported interim results from ACROINNOVA 2¹

LUND, Sweden, July 15, 2024 /PRNewswire/ -- Camurus (NASDAQ: CAMX) (STO: CAMX) today announced positive, final, topline results from the 52-week Phase 3 open-label ACROINNOVA 2 (NCT04125836) study, which evaluated safety and efficacy of the company's once-monthly octreotide subcutaneous (SC) depot (CAM2029). The study included a total of 135 patients with acromegaly who were biochemically controlled (IGF-1≤1xULN) or uncontrolled on stable doses of standard-of-care (SoC) with first generation somatostatin ligands (SRL) at screening; of these, 81 were new to study patients and 54 were roll-over patients from 24-week randomized treatment with octreotide SC depot or placebo (ACROINNOVA 1).

"Today's results from ACROINNOVA 2 highlight the long-term safety profile and efficacy of octreotide SC depot in patients with acromegaly, including patients with uncontrolled disease on standard-of-care," says Fredrik Tiberg, Camurus' President & CEO, CSO. "These data further strengthen the evidence base for CAM2029 octreotide SC depot as a new treatment option for people living with acromegaly, if approved. Regulatory reviews are ongoing in both the US and EU with a first approval decision expected from the US FDA by the PDUFA action date 21 October 2024."

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.

For more information

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

About acromegaly

Acromegaly is a rare, slowly progressive disease, typically caused by a tumor of the pituitary gland producing excess growth hormone and stimulating increased insulin growth factor-1 (IGF-1) levels. This results in abnormal growth of bone and tissue, enlarged hands, feet, facial features and inner organs, and symptoms such as fatigue, joint pain, headache, visual field defects, excessive sweating, and paresthesia.² Inadequate biochemical and symptom control can have detrimental impacts on quality of life and mortality of patients with acromegaly.^3-8 The prevalence of acromegaly is estimated to about 60 cases per million.⁹

About the ACROINNOVA clinical program

ACROINNOVA comprises two Phase 3 trials evaluating efficacy and safety of octreotide SC depot (CAM2029) in patients with acromegaly. The 24-week Phase 3, randomized, double-blind, multi-center, placebo-controlled study (ACROINNOVA 1, NCT04076462) included 72 adult patients who were biochemically controlled (IGF-1≤1xULN) on stable doses of standard-of-care (SoC) at screening and transferred to randomized 2:1 treatment to octreotide SC depot (CAM2029) or placebo. The second study is a 52-week Phase 3 long-term safety and extension trial of octreotide SC depot (ACROINNOVA 2, NCT04125836) in 135 patients with acromegaly on stable treatment with SoC at baseline; 81 new patients directly enrolled in the trial who were either biochemically controlled or uncontrolled at screening (IGF-1<2xULN), and 54 patients who had rolled over from ACROINNOVA 1 after 24 weeks of randomized treatment with CAM2029 or placebo (washed-out patients) and were biochemically controlled at screening (IGF-1≤1xULN). Interim results from ACROINNOVA 2 were announced on 17 July, 2023.¹ The study includes an extension phase with an additional 52-weeks of treatment, which is expected to continue until 2025.

About CAM2029

Octreotide SC depot, CAM2029, is an investigational, ready-to-use octreotide for subcutaneous administration under development for the treatment of acromegaly, as well as gastroentero-pancreatic neuroendocrine tumors (GEP-NET), and polycystic liver disease (PLD). CAM2029 is designed for enhanced octreotide exposure and convenient, once-monthly administration with a prefilled autoinjector pen to facilitate easy self-administration by patients.

The CAM2029 clinical program for acromegaly comprises of seven clinical trials, including four Phase 1 studies, one Phase 2 study, and two Phase 3 studies within the ACROINNOVA clinical program. CAM2029 has demonstrated an approximate five-fold higher bioavailability compared to the currently approved, long-acting, intramuscular (IM) octreotide.¹⁰ In the Phase 3 ACROINNOVA program, CAM2029 showed superior biochemical control compared to placebo as well as improvements in symptom control, treatment satisfaction, and quality of life compared to SoC at baseline with first-generation somatostatin receptor ligands (SRLs), octreotide and lanreotide. The safety profile of CAM2029 was consistent with SoC with no new findings.

About Camurus

Camurus is a Swedish, science-led biopharmaceutical company committed to developing and commercializing innovative, long-acting medicines for the treatment of severe and chronic conditions. New drug products with best-in-class potential are conceived based on the company's proprietary FluidCrystal^® drug delivery technologies and its extensive R&D expertise. Camurus' clinical pipeline includes products for the treatment of dependence, pain, cancer and endocrine diseases, which are developed in-house and in collaboration with international pharmaceutical companies. The company's shares are listed on Nasdaq Stockholm under the ticker CAMX. For more information, visit www.camurus.com.

References

1. Press release 17 July, 2023: https://www.camurus.com/media/press-releases/2023/camurus-announces-new-phase-3-data-reinforcing-long-term-safety-and-efficacy-of-octreotide-sc-depot-cam2029-in-patients-with-acromegaly/ 
2. Colao A., et al. Acromegaly. Nat Rev Dis Primers. 2019;5(1):20.
3. Webb SM, et al. Quality of Life in Acromegaly. Neuroendocrinology. 2016;103(1):106-111.
4. Strasburger CJ, et al. Patient-reported outcomes of parenteral somatostatin analogue injections in 195 patients with acromegaly. Eur J Endocrinol. 2016 Mar;174(3):355-62.
5. Melmed S., et al. Causes and clinical manifestations of acromegaly, UpToDate, last updated May 2020, accessed May 2023.
6. Melmed S., et al. Diagnosis of acromegaly, UpToDate, last updated Dec 2021, accessed May 2023.
7. Katznelson L., et al. Acromegaly: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2014;99(11):3933-51.
8. Holdaway IM, et al. Factors influencing mortality in acromegaly. J Clin Endocrinol Metab. 2004;89(2):667-74
9. Crisafulli S., et al. Global epidemiology of acromegaly: a systematic review and meta-analysis. Eur J Endocrinology. 2021; 185:251-63.
10. Prescribing Information SANDOSTATIN^® LAR, https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021008Orig1s047Corrected_lbl.pdf 

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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SOURCE Camurus AB

FAQ

What were the main results of Camurus' ACROINNOVA 2 Phase 3 study for CAM2029 in acromegaly?

The ACROINNOVA 2 study showed positive results, meeting its primary safety endpoint. It demonstrated increased biochemical response rates, continuous improvement in acromegaly symptoms and quality of life, and a well-tolerated safety profile consistent with standard-of-care for CAM2029 in acromegaly patients.

When is the expected FDA decision date for Camurus' CAM2029 (CAMX)?

The FDA decision for Camurus' CAM2029 (CAMX) is expected by the PDUFA action date of October 21, 2024.

What was the treatment response rate increase in the ACROINNOVA 2 study for CAMX?

The ACROINNOVA 2 study showed a 12.7% increase in treatment response rates overall, and a 22.8% increase in new patients for Camurus' CAM2029 (CAMX) compared to standard-of-care at baseline.

How many patients were included in Camurus' ACROINNOVA 2 Phase 3 study for CAM2029 (CAMX)?

The ACROINNOVA 2 Phase 3 study included a total of 135 acromegaly patients, with 81 new patients and 54 roll-over patients from the previous ACROINNOVA 1 study.