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 and EU for CAM2029 for the treatment of autosomal dominant polycystic liver disease.

Clinicaltrials.gov

<sup>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.</sup>

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

CAM2032

Prostate cancer

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