Drug development firm Rock Creek Pharmaceuticals is seeking regulatory approval to start clinical trials for the continued development of its Anatabine Citrate lead molecule in the UK.
The company has submitted a clinical trial application (CTA) with the UK’s Medicines Healthcare products Regulatory Agency (MHRA).
After securing regulatory approval, Rock Creek aims to undertake a phase I trial to review the safety, tolerability and dose escalation of Anatabine Citrate with the UK-based contract research organisation Quotient Clinical.
Quotient Clinical will employ its Rapid Formulation development And Clinical Testing (RapidFACT) service to test novel, oral, modified release Anatabine Citrate formulations that have been developed jointly with Rock Creek.
Anatabine citrate is a small molecule, cholinergic agonist which shows anti-inflammatory pharmacological characteristics.
Rock Creek said the anti-inflammatory effects have been demonstrated through pre-clinical studies resulting in peer reviewed and published scientific journal articles, covering models of Multiple Sclerosis, Alzheimer’s Disease, and Auto-Immune Thyroiditis.
The company’s compilation of human exposure, safety and tolerability data, derived primarily from human clinical studies of its earlier marketed nutraceutical product, has offered key insights for clinical development.
Rock Creek Pharmaceuticals is focused on the discovery, development and commercialisation of new drugs, formulations and compounds that offer therapies for chronic inflammatory disease, neurologic disorders and behavioral health.