Skip to main contentSkip to navigationSkip to search

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® injection depot technology, developed in-house and in collaboration with international pharmaceutical companies.

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® injection depot technology and is intended for weekly or monthly administration.

CAM2038 is currently under review by the European Medicines Agency (EMA) as an extended indication to Camurus’ launched product Buvidal® to include treatment of chronic pain, adding to the current indication of treating opioid dependence. 

CAM2029

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.

Clinicaltrials.gov

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.

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 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). 

Clinicaltrials.gov

CAM2029 Polycystic liver disease Phase 2/3 clinical trial

Camurus plans to initiate a Phase 2/3 study 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.

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.

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’ 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

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® 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.

CAM2043

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 is being evaluated in a Phase 2 study in patients with Raynaud’s phenomenon secondary to Systemic Sclerosis.

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® 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.