A Randomized, Placebo-controlled, Double-blind, Multi-center Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients With Symptomatic Polycystic Liver Disease

The purpose of the trial is to compare the effectiveness and safety of 2 treatment regimens of CAM2029 (given weekly or every 2 weeks) to placebo in participants with symptomatic PLD, either isolated as in autosomal dominant PLD (ADPLD) or associated with autosomal dominant polycystic kidney disease (ADPKD).
In the Treatment Period of the trial, participants will be allocated at random to 1 of the 3 treatment arms in a 1:1:1 ratio. After completing the Treatment Period (53 weeks) participants may proceed to a 120-week open-label extension part of the trial and then only receive the same CAM2029 treatment.
The active ingredient in CAM2029, octreotide, is administered as a subcutaneous depot using Camurus' FluidCrystal® technology.

Start Date28 Jun 2022

Sponsor / Collaborator

Camurus AB

NCT05050942

/ Active, not recruitingPhase 3

A Randomized, Multi-center, Open-label, Active-controlled Phase 3 Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) Versus Octreotide LAR or Lanreotide ATG in Patients with GEP-NET

The purpose of this study is to compare the effectiveness and safety of CAM2029 to octreotide LAR or lanreotide ATG in patients with advanced, well-differentiated GEP-NET. Patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified treatment with CAM2029.

Start Date22 Oct 2021

Sponsor / Collaborator

Camurus AB

EUCTR2021-000598-95-ES

/ Not yet recruitingPhase 2

A Phase 2, randomized, double-blind, placebo-controlled, multi-center trial to assess the efficacy and safety of octreotide subcutaneous depot (CAM2029) in patients with acute respiratory distress syndrome (ARDS) caused by COVID-19 or other disorders

Start Date30 Jul 2021

Sponsor / Collaborator

Camurus AB

100 Clinical Results associated with Octreotide (Camurus)

100 Translational Medicine associated with Octreotide (Camurus)

100 Patents (Medical) associated with Octreotide (Camurus)

4,397

Literatures (Medical) associated with Octreotide (Camurus)

01 Jan 2025·The American Journal of the Medical Sciences

Comparison of 24 vs 72-hr octreotide infusion in acute esophageal variceal hemorrhage - A multi-center, randomized clinical trial

Article

Author: Rockey, Don C ; Malespin, Miguel ; Lara, Luis F. ; Shuja, Asim ; Agrawal, Deepak ; Feagins, Linda A ; Lara, Luis F ; Allam, Jad ; Rockey, Don C. ; De Melo, Silvio

BACKGROUNDCurrent guidelines lack clarity about the optimal duration of octreotide therapy for patients with esophageal variceal hemorrhage (EVH). To address this lack of evidence, we conducted a randomized clinical trial (RCT) of 24-hr versus 72-hr continuous infusion of octreotide for patients with EVH.METHODSThis multi-center, prospective RCT (NCT03624517), randomized patients with EVH to 24-hr versus 72-hr infusion of octreotide. Patients were required to undergo esophageal variceal band ligation prior to enrollment. The primary endpoint was rebleeding rate at 72 hr. The study was terminated early due to an inability to recruit during and after the COVID-19 epidemic.RESULTSFor patients randomized to 72-hr (n = 19) of octreotide vs 24-hr (n = 15), there were no differences in the need for transfusion, average pRBC units transfused per patient (3 units vs 2 units), infection (5% vs 0%), mechanical ventilation (11% vs 7%), or the need for vasopressors (5% vs 3%), respectively (none of these differences were statistically significantly different). There were 2 re-bleeding events in the 72-hr group (11%), and no re-bleeding events in the 24-hr group (p = 0.49). 8/15 of patients receiving 24 hr of octreotide were discharged at or before hospital day 3 while none in the 72-hr group was discharged before day 3 (p < 0.001). There was one death (in the 72-hr group) within 30 days.CONCLUSIONSA 24-hr infusion is non-inferior to a 72-hr infusion of octreotide for prevention of re-bleeding in patients with EVH. We propose that shortened octreotide duration may help reduce hospital stay and related costs in these patients.

01 Jan 2025·Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy

Utilizing erythrosine B absorption spectrum shifts for quantitative determination of octreotide and bromocriptine in their pure forms and pharmaceutical formulations. Evaluation of the method greenness

Article

Author: Abdulrazik, Shrouk G ; Attia, Tamer Z ; Attia, Tamer Z. ; Abdulrazik, Shrouk G. ; Derayea, Sayed M. ; Derayea, Sayed M

In the present study, two drugs for treating acromegaly are investigated which are either synthetic growth hormone inhibiting hormone (GHIH) or dopamine receptor agonist. Octreotide (OCT) and bromocriptine (BCT) were quantified with a quick, simple, and sensitive spectrophotometric approach in their authentic forms and commercial dosage forms. This approach was based upon formation of ion pair complex between erythrosine B and investigated drugs in an aqueous buffered solution. For OCT determination the higher sensitivity was obtained using ΔA at 525 nm. On the other hand, BCT was estimated using the absorbance at 556 nm. Under optimal conditions for the reaction, construction of calibration curves were performed within concentration range of 0.4-4 µg ml^-1 for OCT and 1-9 µg ml^-1 for BCT with with low detection limits (0.094 and 0.235 µg ml^-1) and low quantitation limits (0.29 and 0.71 µg ml^-1) for OCT and BCT respectively. The developed approach was assessed for linearity, accuracy, precision, limits of detection, and limits of quantitation in compliance with ICH validation recommendations. The suggested approaches demonstrated good linearity, as evidenced by determination coefficients (r²) of 0.999 with a slope 0.14 for OCT and 0.9989 with a slope 0.06 for BCT. Additionally, the environmental friendliness of the investigated method was assessed with some of the recent green analytical chemistry metrics.

18 Dec 2024·The Journal of Clinical Endocrinology & Metabolism

Acromegaly Disease Control Maintained After Switching From Injected Somatostatin Receptor Ligands to Oral Paltusotine

Article

Author: Buchfelder, Michael ; Clemmons, David ; Snyder, Peter J ; Guitelman, Mirtha A ; Mezősi, Emese ; Doknic, Mirjana ; Bidlingmaier, Martin ; Biller, Beverly M K ; Tóth, Miklós ; Casagrande, Alessandra ; Trainer, Peter J ; Fan, Xiaolin ; Shimon, Ilan ; Raverot, Gerald ; Boguszewski, Cesar L ; Strasburger, Christian J ; Gadelha, Mônica R ; Krasner, Alan ; Struthers, R Scott

AbstractContextPaltusotine is a nonpeptide selective somatostatin receptor 2 agonist in development as once-daily oral treatment for acromegaly.ObjectiveTo evaluate the efficacy and safety of paltusotine in the treatment of patients with acromegaly previously controlled with injected somatostatin receptor ligands (SRLs).MethodsThis phase 3, randomized, double-blind, placebo-controlled trial enrolled adults with acromegaly who had IGF-I ≤1.0 times the upper limit of normal (×ULN) while receiving a stable dose of depot octreotide or lanreotide. Patients were switched from injected SRLs and randomized to receive paltusotine or placebo orally for 36 weeks. The primary endpoint was proportion of patients maintaining IGF-I ≤1.0× ULN. Secondary endpoints were change in IGF-I level, change in Acromegaly Symptom Diary score, and maintenance of mean 5-sample GH <1.0 ng/mL.ResultsThe primary endpoint was met: 83.3% (25/30) of patients receiving paltusotine and 3.6% (1/28) receiving placebo maintained IGF-I ≤1.0× ULN (odds ratio, 126.53; 95% CI, 13.73->999.99; P < .0001). Paltusotine was also superior to placebo for all secondary endpoints: mean (± SE) change in IGF-I of 0.04 ± 0.09× ULN vs 0.83 ± 0.1× ULN (P < .0001); mean (± SE) change in Acromegaly Symptom Diary score of −0.6 ± 1.5 vs 4.6 ± 1.6 (P = .02); mean GH maintained at <1.0 ng/mL in 20/23 (87.0%) vs 5/18 (27.8%) patients (odds ratio, 16.61; 95% CI, 2.86-181.36; P = .0003). The most common adverse events were acromegaly symptoms and gastrointestinal effects characteristic of SRLs.ConclusionReplacement of injected SRLs by once-daily oral paltusotine was effective in maintaining both biochemical and symptom control in patients with acromegaly and was well tolerated.

News (Medical) associated with Octreotide (Camurus)

07 Nov 2024

·www.camurus.com

Camurus’ Interim Report Third Quarter 2024

“Solid third quarter and raised full-year outlook” Summary third quarter 2024 July - September January - September Significant events after the period Financial summary third quarter 2024 Excluding one-time milestones related to the Brixadi approval by the FDA in the US in 2023 At constant exchange rate Fredrik Tiberg, President and CEO: “Camurus has had another good quarter with positive financial development and excellent performance across our businesses. Sales of Buvidal and Brixadi continued to grow, resulting in our best result to date, excluding one-time revenues. Our pipeline progressed well with positive Phase 3 results from the ACROINNOVA 2 study, confirming the long-term safety profile and efficacy of CAM2029 in patients with acromegaly. In parallel, our clinical studies of CAM2029 for the treatment of neuroendocrine tumors and polycystic liver disease advanced. In the US, the FDA continued its review of our new drug application for CAM2029 in acromegaly. After the quarter, a Complete Response Letter was received from the Agency, solely relating to a cGMP-inspection at a third-party manufacturing site and pending issuance of an inspection classification.” Audiocast Financial analysts and media are invited to attend a telephone conference and presentation of the results today at 2.00 pm (CET). The conference call can also be followed by a link on www.camurus.com or via external link: https://financialhearings.com/event/48851 For more information: Fredrik Tiberg, President and 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 Camurus Camurus is a Swedish science-led biopharmaceutical company committed to developing and commercializing innovative and differentiated 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 disease, 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. This information is information that Camurus AB is obliged to make public pursuant to the EU Market Abuse Regulation and to the Securities Markets Act. The information was submitted for publication, through the agency of the chief executive officer, at 07.00 am CET on 7 November, 2024.

Financial StatementClinical ResultDrug ApprovalPhase 3

22 Oct 2024

·endpts.com

FDA hits Camurus with CRL for acromegaly therapy over manufacturing issues

The FDA handed a CRL to the Swedish biotech Camurus for its hormone disorder therapy over “facility-related deficiencies” at a third-party manufacturer. The therapy, dubbed CAM2029, had a PDUFA date of Oct. 21 for acromegaly, but production issues were found at a third-party factory in September. There were no issues with the candidate’s efficacy or safety, Camurus said in a Tuesday release. CAM2029 does not have a new decision date, but Camurus said “timely resolution of the CRL” will depend on the unnamed third-party manufacturer’s responses. Labeling discussions for the asset were already in the final stages when the CRL was given, the company said. Acromegaly occurs when the body makes too much growth hormone, which leads to abnormally large hands and feet. Subcutaneously administered CAM2029 features a peptide inhibitor of growth hormones called octreotide. Camurus announced data from a pair of Phase 3 trials investigating CAM2029 in June and July 2023, showing acromegaly symptoms improved in patients. In May, Camurus said the EMA had received its regulatory application. Jefferies analysts said the delay could lead to Camurus launching its drug later than expected. Crinetics Pharmaceuticals has its own acromegaly candidate and announced the submission of its FDA application last month. CAM2029 is also being investigated for gastroenteropancreatic neuroendocrine tumors and polycystic liver disease.

Phase 3NDA

22 Oct 2024

·www.pharmamanufacturing.com

FDA issues CRL to Camurus' hormone disorder drug

The FDA has issued a Complete Response Letter (CRL) for Camurus’ new drug application (NDA) for CAM2029, an extended-release injection for treating acromegaly. The CRL resulted from deficiencies found during a recent inspection of a third-party manufacturer. No concerns were raised regarding CAM2029’s clinical efficacy or safety. Camurus is now collaborating with the FDA and the third-party manufacturer to address the inspection-related observations. Labeling discussions with the FDA had advanced before the CRL, and the prescribing information is well-developed. The regulatory review for CAM2029 in the European Union is ongoing. Additionally, Camurus is advancing two development programs for CAM2029 to treat gastroenteropancreatic neuroendocrine tumors and polycystic liver disease unaffected by the CRL. CAM2029 is a long-acting formulation of octreotide, a somatostatin analogue that works by binding to somatostatin receptors, primarily in the pituitary gland, to inhibit the excessive secretion of growth hormone (GH). By reducing GH levels, CAM2029 helps control the elevated insulin-like growth factor-1 (IGF-1) that drives the symptoms and complications of acromegaly.

NDAOligonucleotide

100 Deals associated with Octreotide (Camurus)

External Link

KEGG	Wiki	ATC	Drug Bank
D11204	-	-	DB00104

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acromegaly	NDA/BLA	US	Camurus AB	05 Mar 2024
Gastro-Enteropancreatic Neuroendocrine Tumor	Phase 3	AU	Camurus AB	22 Oct 2021
Gastro-Enteropancreatic Neuroendocrine Tumor	Phase 3	FR	Camurus AB	22 Oct 2021
Gastro-Enteropancreatic Neuroendocrine Tumor	Phase 3	HU	Camurus AB	22 Oct 2021
Gastro-Enteropancreatic Neuroendocrine Tumor	Phase 3	IT	Camurus AB	22 Oct 2021
Gastro-Enteropancreatic Neuroendocrine Tumor	Phase 3	RO	Camurus AB	22 Oct 2021
Gastro-Enteropancreatic Neuroendocrine Tumor	Phase 3	BE	Camurus AB	22 Oct 2021
Gastro-Enteropancreatic Neuroendocrine Tumor	Phase 3	IL	Camurus AB	22 Oct 2021
Gastro-Enteropancreatic Neuroendocrine Tumor	Phase 3	ES	Camurus AB	22 Oct 2021
Gastro-Enteropancreatic Neuroendocrine Tumor	Phase 3	CA	Camurus AB	22 Oct 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04125836 (ACROINNOVA 2, PRNewswire) Manual	Phase 3	Acromegaly	135	Octreotide SC depot (CAM2029)	(vhiloznrvr) = The most common adverse events (AEs) were mild to moderate injection site reactions and gastrointestinal events. awntrjoxiq (xipnyeqgrf ) View more	Positive	15 Jul 2024
NCT04125836 (ACROINNOVA 2, ENDO2024)	Phase 3	Acromegaly IGF-1	81	CAM2029 20 mg	olibwwogxo(hekbrtoyoz) = n=12 ofwokpsqey (triopdnpkn ) View more	Positive	01 Jun 2024

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