Oclaiz (octreotide subcutaneous depot) / Camurus - LARVOL DELTA

CAM2029 Octreotide Subcutaneous Depot Maintains Control of IGF-I and Symptoms of Acromegaly Across the 4-Week Dosing Interval and During Intervals Greater Than 28 Days: Data from the ACROINNOVA 1 Trial (ENDO 2025) - P3 | "These data inform on the efficacy profile of CAM2029 when administration occurs both within and beyond a 28-day dosing window.*. .*"

Acromegaly • Endocrine Disorders • IGF1 • SSTR

CAM2029, an Octreotide Subcutaneous Depot, Provides Long-Term and Sustained Biochemical Control of Acromegaly: Final Analysis of the Core Part of the ACROINNOVA 2 Phase 3 Trial (ENDO 2025) - P3 | "CAM2029, developed using FluidCrystal® technology, is a long-acting octreotide subcutaneous depot designed for convenient self‑administration via an autoinjector pen. In ACROINNOVA 1, a 24-week (W), Phase 3 trial (NCT04076462), CAM2029 achieved superior biochemical control vs placebo (PBO; 72.2% vs 37.5%; P=0.0018) in patients previously controlled on standard of care (SoC; octreotide long-acting repeatable [LAR]/lanreotide Autogel [ATG])...These results reinforce previous findings, supporting CAM2029 as a new treatment option for acromegaly.*. .*"

P3 data • Acromegaly • Dermatology • Endocrine Disorders • Infectious Disease • Novel Coronavirus Disease • IGF1

Improved Patient‑Reported Outcomes with CAM2029 Treatment, an Octreotide Subcutaneous Depot, in Patients with Acromegaly Previously on Standard-of-Care Injectable Somatostatin Receptor Ligands: Final Analysis of the Core Part of the ACROINNOVA 2 Phase 3 Trial (ENDO 2025) - P3 | "BackgroundStandard-of-care somatostatin receptor ligand therapies (SoC; octreotide long-acting repeatable/lanreotide Autogel) for acromegaly require in-office administration and can be burdensome. CAM2029, a long-acting, octreotide subcutaneous depot developed using FluidCrystal® technology, is conveniently self‑administered via autoinjector pen...CAM2029 has the potential to enhance QoL and treatment satisfaction, both important unmet needs in patients with acromegaly.*. .*"

Clinical • P3 data • Patient reported outcomes • Acromegaly • Endocrine Disorders • SSTR

CHMP recommends approval of Oczyesa for treatment of acromegaly in the EU (PRNewswire) - "Camurus...announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for market authorization of Oczyesa, octreotide subcutaneous depot (CAM2029), for the maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues...The CHMP positive opinion is backed by a comprehensive clinical program comprising seven clinical studies, including two Phase 3 studies. The ACROINNOVA 1 study demonstrated that treatment with Oczyesa results in a significantly higher proportion of patients achieving normalized insulin growth-factor-1 (IGF-1) levels compared to placebo. The persistence of mean IGF-1 values and reduction of symptoms were confirmed over 52 weeks in the ACROINNOVA 2 study....A final decision on the marketing authorization of Oczyesa based on the CHMP recommendation is anticipated from the European Commission in mid-2025."

CHMP • EMA approval • Acromegaly

Results from the core phase of the open-label, Phase 3 ACROINNOVA 2 trial: CAM2029, a subcutaneous octreotide depot, achieves sustained, long-term biochemical control in acromegaly (ESPE-ESE 2025) - No abstract available

Clinical • P3 data • Acromegaly • Endocrine Disorders

CAM2029, a self-administered subcutaneous octreotide depot, improved PROs and symptoms in patients with acromegaly in the ACROINNOVA 2 Phase 3 trial: final analysis of the core phase results (ESPE-ESE 2025) - No abstract available

Clinical • P3 data • Acromegaly • Endocrine Disorders

CAM2029 octreotide subcutaneous depot provides stable control of IGF-I and improves key symptoms throughout a 4-week post-dose interval: analysis from the ACROINNOVA 1 trial (ESPE-ESE 2025) - No abstract available

IGF1

Results from the core phase of the open-label, Phase 3 ACROINNOVA 2 trial: CAM2029, a subcutaneous octreotide depot, achieves sustained, long-term biochemical control in acromegaly (ESPE-ESE 2025) - No abstract available

Clinical • P3 data • Acromegaly • Endocrine Disorders

"Cold" Somatostatin Analogs in Neuroendocrine Neoplasms: Decoding Mechanisms, Overcoming Resistance, and Shaping the Future of Therapy. (PubMed, Cells) - "This paper provides a comprehensive analysis of the cellular and molecular mechanisms of SSAs. SSAs remain integral to the management of NENs, providing effective tumor stabilization and symptom control. However, resistance mechanisms and tumor heterogeneity necessitate innovative approaches, including high-dose regimens, combination strategies, and next-generation formulations. Future research should focus on refining these strategies to optimize patient outcomes, enhance long-term efficacy, and expand the therapeutic landscape for NENs."

Journal • Review • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor • SSTR

SORENTO: A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients with GEP-NET (clinicaltrials.gov) - P3 | N=332 | Active, not recruiting | Sponsor: Camurus AB | Trial completion date: Dec 2026 ➔ Dec 2027 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor • SSTR

The current status of somatostatin analogs in the treatment of neuroendocrine tumors and future perspectives. (PubMed, Expert Rev Neurother) - "Perspectives on emerging nonpeptide SSAs such as paltusotine and innovative formulations of octreotide (CAM2029) are included. Octreotide and lanreotide appear to be clinically interchangeable, and no signs of superiority of one agent over the other has been observed so far. Whether SSAs may be exploited in the maintenance setting following more aggressive treatments, whether continuing SSAs beyond-progression after first-line therapy could be an effective treatment strategy, and whether new-generation SSAs such as pasireotide could overcome resistance to established SSAs are key areas of investigation."

Journal • Review • Carcinoid Tumor • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor

Octreotide subcutaneous depot for acromegaly: A randomized, double-blind, placebo-controlled phase 3 trial, ACROINNOVA 1. (PubMed, J Clin Endocrinol Metab) - P3 | "CAM2029 provides a convenient and effective treatment option for acromegaly, with superior biochemical control versus placebo. Symptom control, QoL and satisfaction were improved from baseline SoC."

Clinical • Journal • P3 data • Acromegaly • Endocrine Disorders • IGF1

POSITANO: A Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With PLD (clinicaltrials.gov) - P2/3 | N=71 | Active, not recruiting | Sponsor: Camurus AB | Trial completion date: Aug 2025 ➔ Aug 2027

Trial completion date • Hepatology

A Randomized Phase 3 Trial to Assess Efficacy and Safety of a Novel Formulation of Octreotide Subcutaneous Depot (CAM2029) in Patients With Acromegaly (AACE 2024) - P3 | "Methods In this Phase 3, multinational, randomized, double-blind, placebo-controlled trial (NCT04076462), patients on stable SoC treatment (octreotide LAR or lanreotide Autogel) who had IGF-1 ≤1x upper limit of normal (ULN) at screening were randomized 2:1 to once-monthly CAM2029 20 mg or placebo for 24 weeks. Discussion/Conclusion CAM2029 provided robust biochemical control of acromegaly superior to placebo, substantially improved PROs vs baseline SoC and placebo, and had a safety profile consistent with SoC. These findings support CAM2029 as a potential therapeutic alternative to SoC acromegaly treatments that addresses unmet patient needs."

Clinical • P3 data • Acromegaly • CNS Disorders • Dermatology • Endocrine Disorders • Gastroenterology • Hepatology • Migraine • Pain • IGF1

CAM2029, Octreotide Subcutaneous Depot, Improves Patient-Reported Outcomes From Standard-of-Care Baseline in Patients With Acromegaly: Interim Results From a Phase 3 Study (ACROINNOVA 2) (ENDO 2024) - P3 | "In a 24-week Phase 3 trial (ACROINNOVA 1), CAM2029 achieved superior insulin-like growth factor 1 (IGF-1) response vs placebo in acromegaly patients (pts) previously controlled with SoC (octreotide LAR/lanreotide Autogel). Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO."

Clinical • P3 data • P3 data: top line • Patient reported outcomes • Acromegaly • Endocrine Disorders • Fatigue • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Pain • IGF1

Efficacy and Safety of CAM2029 in Patients With Controlled or Inadequately Controlled Acromegaly on Standard-of-Care Treatment: Interim Data for the "New to CAM2029" Patient Subgroup in a Phase 3 Study (ACROINNOVA 2) (ENDO 2024) - P3 | "Here, we report interim data from another Phase 3 trial of CAM2029 (ACROINNOVA 2; NCT04125836), focusing on the "New to CAM2029" subgroup of patients whose acromegaly was either controlled or uncontrolled under SoC.MethodsThis 52-week, Phase 3, open-label trial (with a 52-week extension) enrolled patients who had received CAM2029 or placebo in ACROINNOVA 1 (reported separately) and "New to CAM2029" patients who were adequately or inadequately controlled (IGF-1 ≤2x ULN) on a stable dose of octreotide LAR/lanreotide Autogel for ≥3 months (data reported here). Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO."

Clinical • P3 data • P3 data: top line • Acromegaly • Dermatology • Endocrine Disorders • Pain • IGF1

CAM2029, Octreotide Subcutaneous Depot, Provides Sustained Biochemical Control of Acromegaly: Interim Results From a Phase 3 Study (ACROINNOVA 2) (ENDO 2024) - P3 | "In a 24-week Phase 3 trial (ACROINNOVA 1, NCT04076462), CAM2029 achieved superior IGF-1 control vs placebo (IGF-1 ≤ upper limit of normal [ULN]: 72.2 vs 37.5%; P=0.0018) in acromegaly patients previously controlled with standard-of-care (SoC; octreotide long-acting repeatable/lanreotide Autogel). Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO."

P3 data • P3 data: top line • Acromegaly • Endocrine Disorders • Gastroenterology • IGF1

A RANDOMIZED PHASE 3 TRIAL TO ASSESS EFFICACY AND SAFETY OF A NOVEL FORMULATION OF OCTREOTIDE SUBCUTANEOUS DEPOT IN PATIENTS WITH ACROMEGALY (ICE-EDEC 2024) - P3 | " In this phase 3, multinational, randomized, double-blind, placebo-controlled trial (NCT04076462), patients on stable treatment with octreotide LAR or lanreotide autogel, and with normal IGF-1 levels at screening, were randomized 2:1 to once-monthly CAM2029 20 mg or placebo for 24 weeks. CAM2029 treatment resulted in robust biochemical control superior to placebo, substantially improved PROs compared to baseline SoC and placebo, and a safety profile consistent with SoC somatostatin receptor ligand treatments, demonstrating the potential of CAM2029 as an alternative to SoC acromegaly treatments that addresses unmet patient needs."

Clinical • P3 data • Acromegaly • CNS Disorders • Dermatology • Endocrine Disorders • Gastroenterology • Hepatology • Migraine • Pain • IGF1 • SSTR

POSITANO: A Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With PLD (clinicaltrials.gov) - P2/3 | N=71 | Active, not recruiting | Sponsor: Camurus AB | Recruiting ➔ Active, not recruiting

Enrollment closed • Hepatology

SORENTO: A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET (clinicaltrials.gov) - P3 | N=332 | Active, not recruiting | Sponsor: Camurus AB | Recruiting ➔ Active, not recruiting

Enrollment closed • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor • SSTR

Methodology of the SORENTO clinical trial: a prospective, randomised, active-controlled phase 3 trial assessing the efficacy and safety of high exposure octreotide subcutaneous depot (CAM2029) in patients with GEP-NET. (PubMed, Trials) - P3 | "This is the first trial investigating the efficacy of CAM2029 versus SoC SRL therapy using a head-to-head, superiority trial design. It is expected to be the first trial to investigate the efficacy of increased dosing frequency of a high-exposure SRL. A BIRC will limit bias and measurement variability and ensure high-quality efficacy data. Additionally, inclusion of patients with well-differentiated Grade 3 NET may elucidate treatment strategies for this rarely investigated patient population."

Journal • P3 data • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Solid Tumor • SSTR

POSITANO: A Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With PLD (clinicaltrials.gov) - P2/3 | N=69 | Recruiting | Sponsor: Camurus AB | Trial completion date: Aug 2024 ➔ Jun 2025 | Trial primary completion date: Jan 2024 ➔ Dec 2024

Trial completion date • Trial primary completion date • Hepatology

A Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly (clinicaltrials.gov) - P3 | N=135 | Active, not recruiting | Sponsor: Camurus AB | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2023 ➔ Jun 2025 | Trial primary completion date: Sep 2023 ➔ Jun 2025

Enrollment closed • Trial completion date • Trial primary completion date • Acromegaly • Endocrine Disorders • IGF1

Randomized, Placebo-Controlled Phase 3 Trial Protocol Assessing the Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients with Acromegaly (ENDO 2023) - P3 | "Key inclusion criteria included a biochemical and clinical diagnosis of acromegaly due to a pituitary adenoma with persistent or recurrent disease, treatment with a stable dose of octreotide long-acting release or lanreotide Autogel for at least 3 months as monotherapy, and controlled disease with IGF-1 =1 x upper limit of normal (ULN). Key exclusion criteria included GH =2.5 µg/L at screening, pituitary surgery within 6 months of screening, prior pituitary irradiation, and recent treatment with pasireotide, pegvisomant, or dopamine agonists...Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.*"

Clinical • P3 data • Acromegaly • Endocrine Disorders • Oncology • Pituitary Gland Carcinoma • IGF1

A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly (clinicaltrials.gov) - P3 | N=72 | Completed | Sponsor: Camurus AB | Active, not recruiting ➔ Completed

Trial completion • Acromegaly • Endocrine Disorders • IGF1