Phase I Clinical Studies To Begin Using Anatabine Citrate as Possible Therapy For MS

Phase I Clinical Studies To Begin Using Anatabine Citrate as Possible Therapy For MS

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.

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nicotineThe 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.

One comment

  1. jay conway says:

    Preliminary results of the treatment of a mouse model of Multiple Sclerosis with Anatabine.

    Roskamp Institute scientists used a standard model of MS (multiple sclerosis) to assess the effects of anatabine in this disease characterized by very high levels of inflammation in the brain. The mouse model known as EAE (experimental autoimmune enchephalomyelitis) is characterized by high levels of circulating antibodies to the fatty sheaths that surround nerve fibers. The model is induced by vaccinating mice with myelin which induces an autoimmune reaction. As a consequence there is a devastating inflammatory process in the brain which has the effect of destroying neurons and causing progressive paralysis. In this regard the disease model looks very similar to that which occurs in human MS. Treatment with anatabine resulted in a dramatic reduction in the rate of paralysis of hind limbs [see figure 1].

    In addition to the better motor performance of the mice there is evidence of suppression of the normal inflammatory response that accompanies this model. For instance, in the spleen pro-inflammatory molecules such as IFN-γ, IL-8, IL-6 and TNF-α are all significantly raised by the induction of inflammation. In the anatabine treated mice, strikingly, these inflammatory molecules were all at normal levels [figure 2]. These preliminary data all suggest anatabine has a highly beneficial effect in this model of MS.

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