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.
The safety and efficacy of investigational agents and/or investigational uses of approved products have not been established.
CAM2029
Acromegaly, GEP-NET and PLD
CAM2029 – Long-acting octreotide depot with pre-filled pen administration
CAM2029 is long-acting octreotide subcutaneous depot under investigation for acromegaly, gastroenteropancreatic neuroendocrine tumors (GEP-NET) and polycystic liver disease (PLD).
CAM2029 is designed to enable easy self-administration, including the option of a pre-filled pen.
The product candidate is based on Camurus' proprietary FluidCrystal® technology.
CAM2029 Acromegaly Phase 3 clinical trials
The pivotal Phase 3 program for CAM2029, ACROINNOVA, 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.
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.
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).
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 in the US.
Camurus holds Orphan Drug Designation in the US and EU for CAM2029 for the treatment of autosomal dominant polycystic liver disease.
CAM2029
GEP-NET and PLD
CAM2029 – Long-acting octreotide depot with pre-filled pen administration
CAM2029 is long-acting octreotide subcutaneous depot under investigation for gastroenteropancreatic neuroendocrine tumors (GEP-NET) and polycystic liver disease (PLD).
CAM2029 is designed to enable easy self-administration, including the option of a pre-filled pen.
The product candidate is based on Camurus' proprietary FluidCrystal® technology.
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).
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 in the US.
Camurus holds Orphan Drug Designation in the US for CAM2029 for the treatment of autosomal dominant polycystic liver disease.
CAM2038
Chronic pain
CAM2038 – Long-acting buprenorphine depot evaluated for the treatment of chronic pain
CAM2038 is subcutaneous buprenorphine prolonged-release injection being investigated 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 12-month long-term efficacy and safety study also including patients with other chronic pain conditions.
CAM4072
Genetic obesity disorders
CAM4072 – Long-acting setmelanotide depot evaluated for the treatment of genetic obesity disorders
CAM4072 is an investigational weekly formulation of the MC-4 agonist setmelanotide, being studied by Camurus’ license partner Rhythm Pharmaceuticals for the treatment of a range of rare genetic disorders of obesity.
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 an investigational long-acting subcutaneous leuprolide depot candidate being developed for the potential 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 was 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 an investigational 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 chemotherapy-induced nausea and vomiting (CINV)
CAM2047 is an investigational 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 evaluated in a completed Phase 1 study.
CAM4071
Endocrine disorders
CAM4071 – Long-acting pasireotide depot evaluated for the treatment of endocrine disorders
CAM4071 is an investigational long-acting formulation of pasireotide based on FluidCrystal® technology. Pasireotide is currently available as immediate release (IR) in marketed products.
The product candidate has been evaluated in an open-label, active controlled, dose escalating Phase 1 study, assessing pharmacokinetics, pharmacodynamics and safety of CAM4071 in healthy volunteers.
