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R&D Pipeline

Diversified pipeline with large potential

A healthy mix of in-house and partnered  programs

Camurus’ R&D pipeline with programs from early to late stage development is designed to address important unmet medical needs, with the potential to make a significant difference to patients. New product candidates are based on our proprietary FluidCrystal® technology, developed in-house and in collaboration with international pharmaceutical companies.

CAM2029

Acromegaly, GEP-NET and PLD

CAM2029 Long-acting octreotide depot with pre-filled pen administration

CAM2029 is a long-acting octreotide subcutaneous depot under development for the treatment of three rare diseases: acromegaly, gastroenteropancreatic neuroendocrine tumors (GEP-NET) and polycystic liver disease (PLD). 

Studies completed to date demonstrate that CAM2029 has the potential to provide significantly higher octreotide bioavailability and octreotide exposure with the potential for improved treatment efficacy, compared to current market leading products. CAM2029 is designed to enable easy self-administration, including the option of a pre-filled pen. 

CAM2029 is based on Camurus' proprietary FluidCrystal® technology. 

CAM2029 Acromegaly Phase 3 clinical trials

In 2019, the pivotal Phase 3 program for CAM2029 was initiated, ACROINNOVA, which comprises two Phase 3 studies evaluating efficacy and safety of octreotide SC depot (CAM2029) in patients with acromegaly.  

ACROINNOVA 1 is a 24-week, randomized, double-blind, multi-center, placebo-controlled Phase 3 trial that randomized 72 adult patients with acromegaly, who were on stable treatment with octreotide LAR or lanreotide ATG at enrollment. The patients were randomized to receive either CAM2029 or placebo as once monthly injections for 24 weeks. Positive topline results for efficacy and safety were announced in June 2023, see press release

Clinicaltrials.gov

ACROINNOVA 2 is a long-term safety and extension study of CAM2029 in patients with acromegaly. This 52-week, open-label, single-arm and multi-center study includes 135 patients, both new recruited patients as well as rollover patients from ACROINNOVA 1.
Positive interim results for safety and treatment efficacy announced in July 2023, see press release   
Positive topline final results was announced in July 2024, see press release

Clinicaltrials.gov

Camurus holds Orphan Drug Designation in the EU for CAM2029 for the treatment of acromegaly.

CAM2029 GEP-NET Phase 3 clinical trial

In 2021, Camurus initiated a Phase 3 study, the SORENTO study (Subcutaneous Octreotide Randomized Efficacy in Neuroendocrine TumOrs) in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NET). SORENTO is a randomized, multi-center, open-label, active-controlled Phase 3 study including more than 300 participants. The study aims to evaluate the efficacy and safety of long-acting octreotide subcutaneous depot (CAM2029) versus octreotide LAR or lanreotide ATG in patients with well-differentiated GEP-NET. The primary objective is to assess superiority of treatment with CAM2029 compared to current standard of care. Primary endpoint is progression-free survival (PFS), assessed by a blinded independent review committee (BIRC). 

Clinicaltrials.gov

CAM2029 Polycystic liver disease Phase 2/3 clinical trial

In 2022, Camurus initiated a Phase 2/3 study POSITANO (POlycystic liver Safety and effIcacy TriAl with subcutaNeous Octreotide) in patients with symptomatic polycystic liver disease (PLD). The study is a randomized, placebo-controlled, double-blind, multi-center trial to assess efficacy and safety of CAM2029 in patients with symptomatic PLD.

There is currently no approved pharmacological treatment for PLD, but growing scientific evidence has shown that somatostatin analogues, such as octreotide, have shown effect in slowing cyst growth, potential to reduce liver volume and symptom release.1,2

Camurus holds Orphan Drug Designation in the US for CAM2029 for the treatment of autosomal dominant polycystic liver disease.

Clinicaltrials.gov

References
1. Abu-Wasel, B., et al., Pathophysiology, epidemiology, classification and treatment options for polycystic liver diseases. World J   Gastroenterol, 2013. 19(35): p. 5775-86.
2. Perugorria, M.J., et al., Polycystic liver diseases: advanced insights into the molecular mechanisms. Nat Rev Gastroenterol Hepatol, 2014. 11(12): p. 750-61.

CAM2038

Chronic pain

CAM2038 Long-acting buprenorphine depot evaluated for the treatment of chronic pain

CAM2038 is a subcutaneous buprenorphine prolonged-release injection being developed for the treatment of chronic pain. The product candidate is based on Camurus' proprietary FluidCrystal® technology and is intended for weekly or monthly administration.

CAM2038 has been evaluated in a Phase 2 study of CAM2038 in patients with chronic non-cancer pain and opioid dependence, in a randomized, double-blind, placebo-controlled 12-week Phase 3 study in opioid experienced patients with chronic low-back pain, and in a a 12-month long-term efficacy and safety study also including patients with other chronic pain conditions. 

CAM4072

Genetic obesity disorders

CAM4072 Weekly setmelanotide depot evaluated for improved treatment compliance and adherence

CAM4072 is a weekly formulation of the MC-4 agonist setmelanotide, developed by Camurus’ license partner Rhythm Pharmaceuticals for the treatment of a range of rare genetic disorders of obesity. The aim is to offer patients an easier and more convenient dosing regimen with the possibility of improved treatment adherence.

CAM4072 has been evaluated in one Phase 1 study and one Phase 2  study including study participants with severe obesity. During 2023, Rhythm completed a Phase 3 study of weekly CAM4072 in patients with genetic obesity disorders, including Bardet-Biedl’s syndrome (BBS), who were previously treated with daily dosed setmelanotide. 

CAM2032

Prostate cancer

CAM2032 Long-acting leuprolide depot evaluated for the treatment of prostate cancer

CAM2032 is a long-acting subcutaneous leuprolide depot candidate for the treatment of prostate cancer. It is being developed based on Camurus' proprietary FluidCrystal®  technology and is intended for monthly self-administration.

CAM2032 has been evaluated in two Phase 2 studies in patients with prostate cancer. The first study being a first-in-human, single-dose, dose-escalation, open-label study assessing pharmacodynamics (serum testosterone inhibition), pharmacokinetics and safety of subcutaneous (abdominal and buttock) injections of CAM2032. The second study was an open-label, active-controlled, randomized, parallel group study assessing pharmacokinetics, pharmacodynamics, efficacy and safety of repeated doses of CAM2032 versus competitor.

Additional potential indications for CAM2032 include endometriosis and precocious puberty.

CAM2043

Raynaud’s phenomenon and Pulmonary arterial hypertension

CAM2043 Long-acting treprostinil depot evaluated for weekly self-administration

CAM2043 is a long-acting subcutaneous treprostinil depot formulation developed for the treatment of pulmonary arterial hypertension and Raynaud’s phenomenon secondary to systemic sclerosis. The product candidate is based on Camurus’ proprietary FluidCrystal® technology and intended for weekly self-administration.

The product candidate has been evaluated in a completed Phase 1 study assessing  pharmacokinetics, safety and tolerability of once-weekly subcutaneous injections of CAM2043, and in a Phase 2 study in patients with Raynaud’s phenomenon secondary to systemic sclerosis.

CAM2047

Chemotherapy-induced nausea
and vomiting (CINV)

CAM2047 Long-acting subcutaneous granisetron depot evaluated for the treatment of CINV

CAM2047 is a long-acting subcutaneous granisetron depot in development for the treatment of CINV – a side effect experienced by the majority of cancer patients undergoing chemotherapy treatment. CAM2047 has been successfully evaluated in a completed Phase 1 study.

CAM4071

Endocrine disorders

CAM4071 Long-acting pasireotide depot evaluated for the treatment of endocrine disorders

CAM4071 is a long-acting formulation of pasireotide based on FluidCrystal® technology. Pasireotide is currently approved for the treatment of Cushing’s syndrome and acromegaly. 

The product candidate has been successfully evaluated in an open-label, active controlled, dose escalating Phase 1 study, assessing pharmacokinetics, pharmacodynamics and safety of CAM4071 in healthy volunteers.