Rock Creek Pharma (RCPI) Completes Anatabine Citrate Phase 1 Trial in U.K.

October 15, 2015 9:44 AM EDT
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Rock Creek Pharma (NASDAQ: RCPI) announced the successful completion of its three part Phase I clinical trial conducted in the United Kingdom (UK). The overall objective of the Phase I trial was to evaluate safety, tolerability and pharmacokinetic (PK) profiles of different formulations of the Company's lead compound, Anatabine Citrate, in healthy volunteers.

In part one of the Phase I trial, subjects took six different oral formulations of the Company's experimental medication while safety and tolerability were assessed. The formulations differed in dose and time release profile, which produced a range of PK outcomes. All formulations were generally well tolerated with no serious adverse events or safety issues leading to study withdrawal. Part two of the trial examined the effects of food on PK profiles produced by single oral doses of the medication. There were no safety concerns with these "food effect" studies and the medication was again well tolerated. Part three of the Phase I trial was a randomized, double blind, placebo-controlled study design consisting of seven days of oral dosing of the study medication (or placebo) which demonstrated that the Company's compound was safe and well tolerated.

All active treatment parts of the Phase I trial were conducted with the healthy volunteers as inpatients in a clinical trial unit. Although the Company expects to have a formal analysis at a later time, the conclusions from the clinical research organization conducting the studies were that there were no clinically significant changes in any safety assessments including clinical lab tests, vital signs and ECGs in any of the parts of the Phase I trial.

With the completion of this Phase I oral dosing trial, the Company is now poised to conduct a proof-of-concept clinical trial to investigate the safety and efficacy of topical formulations of its lead compound in patients suffering from mild-to-moderate psoriasis. Psoriasis is characterized by an increase in activity of the intracellular transcription factors NF-κB and STAT3, which are responsible for driving the inflammation associated with this disease. Much preclinical data suggests that the Company's lead compound can attenuate the activity of these two transcription factors thus producing anti-inflammatory effects. The Company currently anticipates that a safety and efficacy clinical trial for mild-to-moderate psoriasis will commence in the first half of 2016.

"The Company's lead compound performed very well in the Phase I clinical trial, with regard to safety, tolerability, and the consistency of the PK profiles. Although the collected data will be analyzed more thoroughly in the following weeks and months, the preliminary feedback from the clinical research organization conducting the trial and the Company's medical monitor in the UK suggest there are no safety impediments to continued human clinical trials," Noted Dr Ryan Lanier, Chief Scientific Officer of the Company.

Dr Michael Mullan, the Company's CEO commented "This is an important clinical milestone for the Company signifying, as it does, the first regulatory test of its lead compound in human subjects. We can now look forward to testing the safety and efficacy of this compound in human subjects suffering from psoriasis, a chronic inflammatory condition. We are specifically focused on mild-to-moderate psoriasis, which represents an unmet clinical need and will offer us the opportunity to demonstrate proof of concept of this molecule's novel anti-inflammatory properties."



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