The first healthy participants have been injected with CAM2043 (treprostinil FluidCrystal Injection Depot) in a Phase 1 study assessing the treatment’s safety, tolerability, and pharmacokinetics in both single and repeated doses, the Swedish pharmaceutical company Camurus announced.
CAM2043 contains treprostinil, a therapy that is effective for treating pulmonary arterial hypertension (PAH).
CAM2043 is formulated as a depot injection, meaning it allows a slow release and gradual absorption of the active ingredient. Depot injections are normally administered to deep muscles, but CAM2043 is administered subcutaneously (just under the skin).
“CAM2043 is being developed as a patient-friendly treatment option for easy once-weekly dosing of a small subcutaneous depot injection providing continuous treprostinil exposure in the established therapeutic range,” Fredrik Tiberg, president and ceo of Camurus, said in a press release.
CAM2043 is a gel containing treprostinil, which is considered effective in treating PAH when continuous exposure can be maintained. To date, patients have been required to keep a pump attached to the body at all times to provide continuous infusions, which is inconvenient and burdensome.
Existing treprostinil therapies also are linked with complications, especially severe pain and reactions at infusion sites for patients receiving continuous infusion of the drug.
Camurus’ proprietary FluidCrystal Injection Depot is designed as a once-weekly injection of CAM2043, which is released in the body continuously for one week to maintain treprostinil levels in the patient within the range that produces a therapeutic effect.
During the Phase 1 clinical trial testing CAM2043, the drug’s dose will be increased to assess safety and tolerability in healthy participants. Also, the dose of CAM2043 required to achieve therapeutic levels of treprostinil in the body should be identified by evaluating the pharmacokinetics of CAM2043. Pharmacokinetics is the study of the absorption by the body, distribution, breakdown, and excretion of drugs.
“The further expansion of our clinical pipeline with CAM2043 demonstrates our commitment to improving treatment for patients with severe and chronic disease and illustrates the broad applicability and potential of our proprietary FluidCrystal technology platform,” Tiberg said.
Camurus has developed long-acting injectables for the delivery of a number of different drugs, including buprenorphine for opioid dependence, and other drugs for neuroendocrine cancer and chronic pain.