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news.Rock Creek Pharmaceuticals has submitted an application to the UK Medicines Healthcare products Regulatory Agency (MHRA) for regulatory approval to initiate clinical trials for the continued development of its lead molecule, Anatabine Citrate.
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After securing clinical trial application (CTA) regulatory approval, the company plans to conduct a Phase I trial to assess the safety, tolerability and dose escalation of Anatabine Citrate with the UK based contract research organization, 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 jointly developed with Rock Creek.
Anatabine Citrate is a small molecule, cholinergic agonist that can exhibit anti-inflammatory pharmacological characteristics.
The anti-inflammatory effects have been demonstrated through extensive pre-clinical studies, both in vitro and in vivo, resulting in peer reviewed and published scientific journal articles, covering models of multiple sclerosis, Alzheimer’s disease, and auto-immune thyroiditis.
Apart from the company’s compilation of human exposure, safety and tolerability data, derived primarily from human clinical studies of the company’s previously marketed nutraceutical product, has provided important insights for clinical development of the molecule.