Lpath, Inc., the industry leader in bioactive lipid-targeted therapeutics, has received official notification from European Patent Office (EPO) that the company has been issued a key patent covering monoclonal antibodies against sphingosine-1-phosphate (S1P), including sonepcizumab. S1P is a bioactive lipid that has been validated as a target in multiple disease states.
This newly granted patent, European patent No. 1 948 234, claims, among other things, humanized monoclonal antibodies directed against S1P for use in treating a wide range of ocular conditions, including age-related macular degeneration (AMD), diabetic retinopathy and others.
"This key patent provides exclusivity in Europe for our lead S1P programme in wet AMD in which dysfunctional angiogenesis, inflammation and scarring contribute to disease progression," said Roger Sabbadini, Lpath's vice president, founder, and inventor of the granted patent. "It also provides us exclusivity in our pursuit of other ocular disorders where we believe dysfunctional levels of S1P may be involved in pathogenesis of disease."
ASONEP and iSONEP are different formulations of sonepcizumab, a first-in-class therapeutic antibody against S1P developed by Lpath's ImmuneY2 drug-discovery engine. Antibodies developed via this discovery engine are designed to target bioactive signaling lipids, such as S1P, that are involved in the proliferation and spread of cancer, AMD, inflammatory and auto-immune disorders, and many other diseases.
Lpath recently completed two early-stage clinical trials using the two anti-S1P antibody formulations: iSONEP was evaluated in a phase I trial in wet-AMD subjects, and ASONEP was evaluated in a phase I trial in cancer subjects.
Lpath has initiated a phase II clinical trial for iSONEP, called Nexus, which is evaluating the anti-S1P antibody's safety and efficacy in wet-AMD patients. Lpath entered into an agreement with Pfizer in 2010 that provides Pfizer an exclusive option for a worldwide licence to develop and commercialise iSONEP.
Lpath is also independently pursuing an ASONEP phase II trial in renal cell carcinoma and will open this trial soon.
Lpath was also recently granted a Russian patent (2009120052) and a U.S. patent (8,222,373) with composition and methods claims relating to sonepcizumab.
Lpath has achieved a broad and deep intellectual property position in the bioactive-lipid area. The company's comprehensive patent portfolio now includes 33 issued patents (including nine international) and 109 patent applications (including 82 international). These patents primarily relate to the use of reagents and methods designed to interfere with the actions of bioactive lipids involved in human disease. Lpath's intellectual property portfolio includes coverage of compositions of matter that specifically bind to sphingolipids and sphingolipid metabolites. These compositions, including antibodies, could be used in the diagnosis and treatment of various diseases and disorders, including cardiovascular and cerebrovascular disease, cancer, inflammation, autoimmune disorders, ocular disease, and angiogenesis.