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® injection depot technology, developed in-house and in collaboration with international pharmaceutical companies.
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® injection depot 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.
Acromegaly, GEP-NET and PLD
CAM2029 – Long-acting octreotide depot with pre-filled pen administration
CAM2029 is a long-acting subcutaneous depot of octreotide 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 device.
CAM2029 is based on Camurus' proprietary FluidCrystal® injection depot technology.
CAM2029 Acromegaly Phase 3 clinical trials
In 2019, the pivotal Phase 3 program for CAM2029 was initiated and two Phase 3 trials are currently ongoing.
The Phase 3 efficacy and safety study is a multi-center, randomized, double-blind, placebo-controlled trial to assess efficacy and safety of CAM2029 in patients with acromegaly. A total of 78 participants are randomized to receive either CAM2029 or placebo as once monthly injections for 24 weeks. Primary efficacy readout is biochemical response, as measured by insulin-like growth factor 1 (IGF-1) levels.
The Phase 3 long-term safety study of CAM2029 is a 52-week, open-label, single-arm and multi-center study including both newly recruited and partially stable acromegaly patients as well as rollover patients from the Phase 3 efficacy and safety study. An estimated 140 participants will be enrolled in the study, who will be administered once monthly subcutaneous injections of CAM2029 during the study period.
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 with approximately 300 participants planned to be enrolled. 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 2b clinical trial
In 2022, Camurus initiated a Phase 2b 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.
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.
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’ partner Rhythm Pharmaceuticals for the treatment of a range of rare genetic disorders of obesity. The product candidate is based on Camurus' proprietary FluidCrystal® injection depot technology and intended for weekly self-administration and is designed to improve compliance and adherence.
Rhythm has started a pivotal study program for CAM4072. A Phase 3 randomized, double-blind switch study is ongoing, expected to enroll 30 patients who were previously enrolled in Rhythm’s long-term, open-label daily setmelanotide extension trial. In addition Rhythm is in the process of starting a second Phase 3 de novo study evaluating weekly depot of setmelanotide in patients with Bardet-Biedl Syndrome (BBS) who have not previously received treatment.
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® injection depot 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.
Pulmonary arterial hypertension and Raynaud’s phenomenon
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® injection depot 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.
CAM2043 has also been evaluated in a Phase 2 study in patients with Raynaud’s phenomenon secondary to Systemic Sclerosis.
CAM4071 – Long-acting pasireotide depot evaluated for the treatment of endocrine disorders
CAM4071 is a long-acting formulation of pasireotide based on FluidCrystal® injection depot 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.