Resverlogix Corp. (Resverlogix), a clinical stage cardiovascular company developing compounds involving ApoA-I production, has received confirmation from European Patent Office that its patent application covering RVX-208 has been granted. European Patent no. 2118074 is titled "Compounds for the prevention and treatment of cardiovascular diseases." The patent life will extend to February 2027.
"We are delighted to have confirmation of this news," stated Don McCaffrey, president and CEO of Resverlogix. "This additional patent builds upon the growing patent estate for RVX-208, our core asset. With a patent life out to 2027, RVX-208 now has critical protection for the next 13 years in the important European marketplace" McCaffrey added. In addition, Resverlogix has also filed for a fixed dose combination patent, with Rosuvastatin, that if granted will extend the patent life to 2033.
Resverlogix also announced that it entered into a Waiver Agreement with RVX Therapeutics Inc. (RVX Therapeutics), a wholly-owned subsidiary of Zenith Epigenetics Corp., whereby Resverlogix agreed to waive its right under a License Agreement dated June 3, 2013 to license any method or pharmaceutical agent within the scope of certain Licensee Patents owned or controlled by RVX Therapeutics that may be determined to come within the ApoA-I Therapeutic Field (as defined in the License Agreement), and RVX Therapeutics agreed not to develop any patents and/or compounds for any indication within the ApoA-I Therapeutic Field for a period of five years. RVX Therapeutics agreed to pay Resverlogix $2.5 million in cash and granted to Resverlogix a right of first refusal for a period of three years thereafter in respect of the license or sale of such patents and/or compounds that are determined to come within the ApoA-I Therapeutic Field. Entering into the Waiver Agreement generated cash for Resverlogix without impacting on its core assets.
In unrelated news, the company also announced that a March publication in Cell Metabolism titled "High Density Lipoproteins and Cerebrovascular Integrity in Alzheimer's Disease" includes discussion of RVX-208, Resverlogix's small molecule ApoA-I modulator, as a potential therapeutic for Alzheimer's Disease (AD) (Stukas et al., 2014 Cell Metabolism 19: 1-18). Prior exploratory clinical data on the effect of RVX-208 on plasma amyloid beta levels, performed from the phase Ia and phase II ASSERT studies, is discussed. As these earlier cardiovascular trials were not specifically designed to study Alzheimer's disease, efforts are being undertaken to advance an exploratory trial in an AD patient population. The company is planning a phase II clinical trial for the Exploratory Assessment of Alzheimer's Disease following Treatment with RVX-208 in Patients with Alzheimer's and Alzheimer's-like Dementia of Possible Vascular Origin. The trial will target mild to moderate Alzheimer's disease patients.
Additionally, Resverlogix has restructured its clinical CVD programme, which will now be formally directed by Dr. Jan Johansson. The Company would like to thank Dr. Allan Gordon for his years of service, and wishes him great success in his future endeavours.
RVX-208 is a first-in-class small molecule that inhibits BET bromodomains. RVX-208 functions by removing atherosclerotic plaque via reverse cholesterol transport (RCT), the natural process through which atherosclerotic plaque is transported out of the arteries and removed from the body by the liver. RVX-208 increases production of Apolipoprotein A-I (ApoA-I), the key building block of functional high-density lipoprotein (HDL) particles and the type required for RCT. These newly produced, functional HDL particles are flat and empty and can efficiently remove plaque and stabilize or reverse atherosclerotic disease. Analysis of recent clinical trials data showed that RVX-208 significantly reduces coronary atherosclerosis and major adverse cardiac events in patients with CVD who have a low level of HDL and elevated CRP, a population with unmet medical need. ApoA-I may also exert beneficial effects in Alzheimer's disease and Diabetes Mellitus. RVX-208 also has anti-inflammatory effects including effects on Interleukin-6 inhibition, vascular cell adhesion-1 and monocyte chemotactic protein-1, factors known to be involved in atherosclerosis and plaque stability.