Treatment well tolerated with a safety profile consistent with standard-of-care (SoC)

治疗耐受性良好，安全性符合护理标准（SoC）

Increased biochemical response rates (IGF-1≤1xULN) vs SoC at baseline

基线时生化反应率（IGF-1≤1xULN）与SoC的关系增加

Continuous improvement of acromegaly symptom and quality of life scores vs baseline

肢端肥大症症状和生活质量评分与基线的持续改善

Study results reinforce previously reported interim results from ACROINNOVA 21

研究结果强化了先前报道的ACROINNOVA 21的中期结果

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).

瑞典隆德，2024年7月15日/PRNewswire/-Camurus（NASDAQ:CAMX）（STO:CAMX）今天宣布了为期52周的第三阶段开放标签ACROINNOVA 2（NCT04125836）研究的最终结果，该研究评估了该公司每月一次的奥曲肽皮下（SC）仓库（CAM2029）的安全性和有效性。

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)..

该研究共纳入135例肢端肥大症患者，这些患者在筛查时被生化控制（IGF-1≤1xULN）或不受稳定剂量的标准治疗（SoC）和第一代生长抑素配体（SRL）的控制；其中，81名是新研究患者，54名是奥曲肽SC仓库或安慰剂（ACROINNOVA 1）24周随机治疗的翻身患者。。

'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.

Camurus的CSO总裁兼首席执行官弗雷德里克·蒂贝格（FredrikTiberg）说：“今天来自ACROINNOVA 2的研究结果突出了奥曲肽SC仓库对肢端肥大症患者的长期安全性和有效性，包括标准护理中未控制疾病的患者。”如果获得批准，这些数据进一步加强了CAM2029奥曲肽SC仓库作为肢端肥大症患者的新治疗选择的证据基础。

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.'.

美国和欧盟正在进行监管审查，预计美国食品和药物管理局将在2024年10月21日的PDUFA行动日做出第一个批准决定。”。

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.

主要终点是52周研究治疗的安全性。奥曲肽SC仓库耐受性良好，长期安全性与第一代生长抑素受体配体（SRL），缓释奥曲肽和兰瑞肽的SoC一致，没有新的安全信号。最常见的不良事件（AE）是轻度至中度注射部位反应和胃肠道事件。

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..

没有与奥曲肽SC仓库相关的严重AE病例。一名患者出现了与治疗相关的胆石症严重不良事件（中度），并得到了解决，患者在试验中继续治疗。两名患者（1.5%）因不良事件停止治疗；轻度抑郁症1例，轻度注射部位出血1例。。

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.

ACROINNOVA 2包括多个次要终点，包括生化控制率，症状评分和一些患者报告的结果。奥曲肽SC仓库治疗52周后，总体人群的治疗反应率显着增加12.7%（95%CI:5.5%，19.9%），新患者的治疗反应率显着增加22.8%（95%CI:11.6,33.9）基线时的SoC。

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..

在SoC基线时具有受控IGF-1值的翻身患者在用奥曲肽SC仓库治疗期间维持或恢复（对于安慰剂）生化控制。与基线时的SoC相比，奥曲肽SC仓库的治疗也导致肢端肥大症症状评分和患者报告结果的持续改善，包括治疗满意度，肢端肥大症生活质量和自我注射评估评分。。

'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.

“ACROINNOVA 2的结果非常令人鼓舞，并证明CAM2029奥曲肽SC仓库可有效使患者组的IGF-1水平正常化，并在整个52周的治疗过程中持续改善肢端肥大症的症状。此外，使用预充式自动注射器笔每月一次SC给药的便利性有助于提高治疗满意度和生活质量，这对于肢端肥大症患者来说是重要的未满足需求，”医学博士JoannaSpencerSegal说。

Professor of Internal Medicine, Div. of Metabolism, Endocrinology and Diabetes, University of Michigan, Ann Arbor, Michigan, US, and ACROINNOVA 2 study investigator..

美国密歇根州安阿伯市密歇根大学代谢，内分泌和糖尿病系内科教授，以及ACROINNOVA 2研究研究员。。

For more information

有关更多信息

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

总裁兼首席执行官Fredrik Tiberg+46 (0)46 286 4692fredrik.tiberg@camurus.com

Fredrik Joabsson, Chief Business Development OfficerTel. +46 (0)70 776 17 37ir@camurus.com

弗雷德里克·乔布森（FredrikJoabsson），首席商业发展办公室（Certel）+46（0）70 776 1737ir@camurus.com

About acromegaly

关于肢端肥大症

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.

肢端肥大症是一种罕见的缓慢进展性疾病，通常由垂体肿瘤引起，产生过量的生长激素并刺激胰岛素生长因子-1（IGF-1）水平升高。这导致骨骼和组织异常生长，手脚，面部特征和内脏肿大，以及疲劳，关节疼痛，头痛，视野缺损，出汗过多和感觉异常等症状。生化和症状控制不足可能对肢端肥大症患者的生活质量和死亡率产生不利影响。3-8肢端肥大症的患病率估计约为百万分之六十。

About the ACROINNOVA clinical program

关于ACROINNOVA临床计划

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.

ACROINNOVA包括两项3期临床试验，评估奥曲肽SC depot（CAM2029）对肢端肥大症患者的疗效和安全性。这项为期24周的3期随机、双盲、多中心、安慰剂对照研究（ACROINOVA 1，NCT04076462）包括72名成年患者，这些患者在筛查时接受了稳定剂量的标准治疗（SoC），并接受了奥曲肽SC仓库（CAM2029）或安慰剂的2:1随机治疗。

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).

第二项研究是一项为期52周的奥曲肽SC depot（ACROINNOVA 2，NCT04125836）3期长期安全性和延长试验，对135例肢端肥大症患者进行基线SoC稳定治疗；81名直接参加试验的新患者在筛查时受到生化控制或不受控制（IGF-1<2xULN），54名患者在接受CAM2029或安慰剂随机治疗24周后从ACROINNOVA 1翻身（淘汰患者），并在筛查时受到生化控制（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..

ACROINNOVA 2的中期结果于2023年7月17日公布。该研究包括延长阶段，再进行52周的治疗，预计将持续到2025年。。

About CAM2029

关于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..

奥曲肽SC仓库CAM2029是一种研究性的，即用型奥曲肽，用于皮下给药，正在开发中，用于治疗肢端肥大症，胃肠胰神经内分泌肿瘤（GEP-NET）和多囊肝病（PLD）。CAM2029旨在增强奥曲肽的暴露，并使用预充自动注射器笔方便地每月一次给药，以方便患者自我给药。。

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.

CAM2029肢端肥大症临床计划包括七项临床试验，包括ACROINNOVA临床计划中的四项1期研究，一项2期研究和两项3期研究。与目前批准的长效肌内（IM）奥曲肽相比，CAM2029的生物利用度高出约五倍[10]。在3期ACROINNOVA计划中，与安慰剂相比，CAM2029显示出更好的生化控制以及症状控制，治疗满意度和生活质量比第一代生长抑素受体配体（SRLs），奥曲肽和兰瑞肽的基线SoC有所改善。

The safety profile of CAM2029 was consistent with SoC with no new findings..

CAM2029的安全性与SoC一致，没有新发现。。

About Camurus

关于卡穆鲁斯

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是一家以科学为主导的瑞典生物制药公司，致力于开发和商业化用于治疗严重和慢性疾病的创新长效药物。基于该公司专有的FluidCrystal®药物输送技术及其广泛的研发专业知识，构思出具有同类最佳潜力的新药。

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..

卡穆鲁斯的临床渠道包括用于治疗依赖、疼痛、癌症和内分泌疾病的产品，这些产品是内部开发的，并与国际制药公司合作开发的。该公司股票在纳斯达克斯德哥尔摩证券交易所以CAMX股票代码上市。有关更多信息，请访问www.camurus.com。。

References

参考文献

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/

2023年7月17日新闻稿：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/

Colao A., et al. Acromegaly. Nat Rev Dis Primers. 2019;5(1):20.

Colao A.等人，肢端肥大症。Nat Rev Dis入门。2019;5(1):20.

Webb SM, et al. Quality of Life in Acromegaly. Neuroendocrinology. 2016;103(1):106-111.

Webb SM等人。肢端肥大症的生活质量。神经内分泌学。2016年；103（1）：106-111。

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.

Strasburger CJ等人报道了195例肢端肥大症患者肠胃外注射生长抑素类似物的结果。Eur J内分泌。2016年3月；174（3）：355-62。

Melmed S., et al. Causes and clinical manifestations of acromegaly, UpToDate, last updated May 2020, accessed May 2023.

Melmed S.等人，《肢端肥大症的病因和临床表现》，最新更新于2020年5月，2023年5月访问。

Melmed S., et al. Diagnosis of acromegaly, UpToDate, last updated Dec 2021, accessed May 2023.

Melmed S.等人，《肢端肥大症的诊断》，UpToDate，最后更新于2021年12月，2023年5月访问。

Katznelson L., et al. Acromegaly: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2014;99(11):3933-51.

Katznelson L.等人，《肢端肥大症：内分泌学会临床实践指南》。J临床内分泌代谢。2014年；99（11）：3933-51。

Holdaway IM, et al. Factors influencing mortality in acromegaly. J Clin Endocrinol Metab. 2004;89(2):667-74

Holdaway IM等人。影响肢端肥大症死亡率的因素。J临床内分泌代谢。2004年；89（2）：667-74

Crisafulli S., et al. Global epidemiology of acromegaly: a systematic review and meta-analysis. Eur J Endocrinology. 2021; 185:251-63.

Crisafulli S.等人，《肢端肥大症的全球流行病学：系统综述和荟萃分析》。Eur J内分泌学。2021年；185:251-63。

Prescribing Information SANDOSTATIN® LAR, https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021008Orig1s047Corrected_lbl.pdf

处方信息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.

根据欧盟市场滥用法规，卡穆鲁斯公司有义务公布该信息。该信息于2024年7月15日上午7:30通过总经理代理提交出版。

This information was brought to you by Cision http://news.cision.com

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以下文件可供下载：

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Press release

新闻稿