Camurus proclaims constructive Part 3 outcomes from the ACROINNOVA 2 examine of octreotide SC depot (CAM2029) in acromegaly sufferers By Investing.com

• Therapy nicely tolerated with a security profile in line with standard-of-care (SoC)
• Elevated biochemical response charges (IGF-1 ‰¤1xULN) vs SoC at baseline
• Steady enchancment of acromegaly symptom and high quality of life scores vs baseline
• Research outcomes reinforce beforehand reported interim outcomes from ACROINNOVA 2¹

LUND, Sweden, July 15, 2024 /PRNewswire/ — Camurus (NASDAQ: CAMX) (STO: CAMX) at the moment introduced constructive, closing, topline outcomes from the 52-week Part 3 open-label ACROINNOVA 2 (NCT04125836) examine, which evaluated security and efficacy of the corporate’s once-monthly octreotide subcutaneous (SC) depot (CAM2029). The examine included a complete of 135 sufferers with acromegaly who have been biochemically managed (IGF-1 ‰¤1xULN) or uncontrolled on secure doses of standard-of-care (SoC) with first technology somatostatin ligands (SRL) at screening; of those, 81 have been new to check sufferers and 54 have been roll-over sufferers from 24-week randomized therapy 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 first endpoint was security over 52 weeks of examine therapy. Octreotide SC depot was nicely tolerated with a long-term security profile in line with that of SoC with first technology somatostatin receptor ligands (SRL), extended-release octreotide and lanreotide, with no new security alerts. The commonest adversarial occasions (AEs) have been delicate to reasonable injection web site reactions and gastrointestinal occasions. There have been no circumstances of extreme AEs associated to octreotide SC depot. One affected person had a treatment-related critical adversarial occasion of cholelithiasis (reasonable), which resolved, and the affected person continued therapy within the trial. Two sufferers (1.5%) discontinued therapy attributable to AEs; one case of delicate despair and as soon as case of delicate injection web site hemorrhage.

ACROINNOVA 2 included a number of secondary endpoints, together with biochemical management charges, symptom scores, and a number of other patient-reported outcomes. Therapy with octreotide SC depot over 52 weeks resulted in vital will increase in therapy response charges of 12.7% (95percentCI: 5.5%, 19.9%) within the general inhabitants, and 22.8% (95percentCI: 11.6, 33.9) in new sufferers in contrast SoC at baseline. Roll-over sufferers, with managed IGF-1 values on the SoC baseline, maintained or regained (for placebo) biochemical management throughout therapy with octreotide SC depot. Therapy with octreotide SC depot additionally resulted in steady enchancment of acromegaly symptom scores and affected person reported outcomes, together with therapy satisfaction, acromegaly high quality of life, and self-injection evaluation scores in comparison with 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 Inside Medication, Div. of Metabolism, Endocrinology and Diabetes, College of Michigan, Ann Arbor, Michigan, US, and ACROINNOVA 2 examine investigator.

For extra data

Fredrik Tiberg, President & CEO
Tel. +46 (0)46 286 46 92
fredrik.tiberg@camurus.com

Fredrik Joabsson, Chief Business Improvement Officer
Tel. +46 (0)70 776 17 37
ir@camurus.com

About acromegaly

Acromegaly is a uncommon, slowly progressive illness, usually attributable to a tumor of the pituitary gland producing extra progress hormone and stimulating elevated insulin progress factor-1 (IGF-1) ranges. This leads to irregular progress of bone and tissue, enlarged palms, ft, facial options and internal organs, and signs reminiscent of fatigue, joint ache, headache, visible discipline defects, extreme sweating, and paresthesia.²  Insufficient biochemical and symptom management can have detrimental impacts on high quality of life and mortality of sufferers with acromegaly.^3-8 The prevalence of acromegaly is estimated to about 60 circumstances per million.⁹

Concerning the ACROINNOVA scientific program

ACROINNOVA contains two Part 3 trials evaluating efficacy and security of octreotide SC depot (CAM2029) in sufferers with acromegaly. The 24-week Part 3, randomized, double-blind, multi-center, placebo-controlled examine (ACROINNOVA 1, NCT04076462) included 72 grownup sufferers who have been biochemically managed (IGF-1 ‰¤1xULN) on secure doses of standard-of-care (SoC) at screening and transferred to randomized 2:1 therapy to octreotide SC depot (CAM2029) or placebo. The second examine is a 52-week Part 3 long-term security and extension trial of octreotide SC depot (ACROINNOVA 2, NCT04125836) in 135 sufferers with acromegaly on secure therapy with SoC at baseline; 81 new sufferers straight enrolled within the trial who have been both biochemically managed or uncontrolled at screening (IGF-117 July, 2023.¹ The examine contains an extension part with an extra 52-weeks of therapy, which is anticipated to proceed till 2025.

About CAM2029

Octreotide SC depot, CAM2029, is an investigational, ready-to-use octreotide for subcutaneous administration below improvement for the therapy of acromegaly, in addition to gastroentero-pancreatic neuroendocrine tumors (GEP-NET), and polycystic liver illness (PLD). CAM2029 is designed for enhanced octreotide publicity and handy, once-monthly administration with a prefilled autoinjector pen to facilitate simple self-administration by sufferers.

The CAM2029 scientific program for acromegaly contains of seven scientific trials, together with 4 Part 1 research, one Part 2 examine, and two Part 3 research inside the ACROINNOVA scientific program. CAM2029 has demonstrated an approximate five-fold increased bioavailability in comparison with the at present permitted, long-acting, intramuscular (IM) octreotide.¹⁰  Within the Part 3 ACROINNOVA program, CAM2029 confirmed superior biochemical management in comparison with placebo in addition to enhancements in symptom management, therapy satisfaction, and high quality of life in comparison with SoC at baseline with first-generation somatostatin receptor ligands (SRLs), octreotide and lanreotide. The protection profile of CAM2029 was in line with SoC with no new findings.

About Camurus

Camurus is a Swedish, science-led biopharmaceutical firm dedicated to creating and commercializing progressive, long-acting medicines for the therapy of extreme and persistent situations. New drug merchandise with best-in-class potential are conceived primarily based on the corporate’s proprietary FluidCrystal ^®  drug supply applied sciences and its intensive R&D experience. Camurus’ scientific pipeline contains merchandise for the therapy of dependence, ache, most cancers and endocrine illnesses, that are developed in-house and in collaboration with worldwide pharmaceutical firms. The corporate’s shares are listed on Nasdaq Stockholm below the ticker CAMX. For extra data, go to www.camurus.com.

References

1. Press launch 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. High quality of Life in Acromegaly. Neuroendocrinology. 2016;103(1):106-111.
4. Strasburger CJ, et al. Affected person-reported outcomes of parenteral somatostatin analogue injections in 195 sufferers with acromegaly. Eur J Endocrinol. 2016 Mar;174(3):355-62.
5. Melmed S., et al. Causes and scientific manifestations of acromegaly, UpToDate, final up to date Might 2020, accessed Might 2023.
6. Melmed S., et al. Analysis of acromegaly, UpToDate, final up to date Dec 2021, accessed Might 2023.
7. Katznelson L., et al. Acromegaly: An Endocrine Society Scientific Apply Guideline. J Clin Endocrinol Metab. 2014;99(11):3933-51.
8. Holdaway IM, et al. Elements influencing mortality in acromegaly. J Clin Endocrinol Metab. 2004;89(2):667-74
9. Crisafulli S., et al. World epidemiology of acromegaly: a scientific evaluate and meta-analysis. Eur J Endocrinology. 2021; 185:251-63.
10. Prescribing Info SANDOSTATIN ^®  LAR, https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021008Orig1s047Corrected_lbl.pdf  

This data is data that Camurus AB is obliged to make public pursuant to the EU Market Abuse Regulation. The data was submitted for publication, via the company of the managing director, at 7:30 am CET on 15 July 2024.

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