Drug development company Rock Creek Pharmaceuticals, Inc. recently announced that a new clinical trial application with the United Kingdom’s Medicines Healthcare Products Regulatory Agency (MHRA) has been approved. The company is set to proceed with a Phase I study of its flagship pipeline product, Anatabine Citrate, a chemical that is found naturally in eggplant, potatoes, green tomatoes and other members of the Solanaceae family of plants, as well as in tobacco and tobacco smoke. The chemical is known for its anti-inflammatory properties unique from other anti-inflammatory drugs on the market, and may benefit patients with multiple sclerosis (MS).
The Phase I study will be composed of three portions, designed to evaluate Anatabine’s pharmacokinetic profile in the form of modified release formulation prototypes, and its safety and tolerability profiles in healthy volunteers. The first two parts will involve an open-label, non-controlled, single-dose study on 14 healthy participants, using six formula variations, with each administered dose spaced 7-14 days apart. The variations will be distinct in dose and duration of therapeutic action. This will allow the company to determine which formulation is most ideal, based on safety. The third and last part of the Phase I study will be a double-blind, placebo-controlled, seven-day multiple dose study of the identified optimal formulation in healthy subjects.
The Phase I clinical trial will base its success on two outcome measures, namely: “overall safety and tolerability through physical examination, vital signs, clinical chemistry, hematology, urinalysis and observation of adverse events (AE)” and “standard pharmacokinetics (PK) parameters and also pharmacodynamic (PD) assessment, specifically measuring the impact of the drug on inflammatory processes.”
“We are delighted to have been granted regulatory approval to begin our Phase I studies in the UK. This is the first clinical phase for our lead drug and will focus on safety and tolerability of six different formulations, 5 of which have modified release profiles and are of different doses. We look forward to generating our first human clinical data under this CTA,” said Dr. Michael Mullan, CEO of Rock Creek Pharmaceuticals.
Rock Creek’s UK-based partner, Quotient Clinical, is set to begin enrollment of healthy subjects this February 2015. While the company expects the study to stretch well into August, they expect to have a significant amount of research findings by mid-2015. Rock Creek also announced Quotient Clinical will be utilizing its RapidFACT® (Rapid Formulation development And Clinical Testing) service to hasten the development of these novel, oral, modified release formulations that have been co-developed between the two companies.