Brief Overview
Lpath, Inc. is the leader in the discovery and development of monoclonal antibodies targeted to bioactive lipids. Lipid-based therapeutics are an emerging field of medical science whereby bioactive signaling lipids are targeted for treating important human diseases that currently lack innovative and effective medicines.
Lpath's lead product candidate, iSONEPTM, is currently in two clinical trials, including (i) A Phase 1b study designed to evaluate the safety and potential efficacy of iSONEP for the treatment of Pigment Epithelial Detachment (PED) in wet AMD patients; and (ii) A Phase 2 study to determine the safety and efficacy of iSONEP given alone or in combination with Lucentis® or Avastin® in subjects with wet Age-related Macular Degeneration (AMD).
In the phase I trial in wet AMD patients, iSONEP met its primary endpoint of being well tolerated in all 15 patients at dose-levels ranging from 0.2 mg. to 1.8 mg. per intravitreal injection (three patients per dose level). No drug-related serious adverse events were reported in any of the patients. iSONEP also succeeded in meeting a key secondary endpoint in that positive biological effects (including lesion regression, reduction of retinal thickness, and resolution of pigment epithelial detachment) were observed in an encouraging number of patients. Most of these positive effects appear to be largely independent of the effects seen when wet-AMD patients undergo treatment with Lucentis® or with off-label use of Avastin®, the predominant market leaders. iSONEP™ also demonstrated excellent results in various preclinical AMD models and first-in-class results in a preclinical model of diabetic retinopathy. The drug candidate exhibits anti-fibrotic and anti-inflammatory properties, which might provide comparative advantages in a variety of ocular diseases. In December 2010, Lpath announced a collaboration agreement with Pfizer Inc. for the further clinical development of iSONEP. If successful, this collaboration could result in payments up to $517.5 million plus tiered double digit royalties to Lpath (Download PDF).
Lpath's second product candidate, ASONEPTM, is a monoclonal antibody against sphingosine-1-phosphate (S1P) that has completed a phase I clinical trial in cancer patients, where it was deemed well tolerated at dose levels up to 24 mg/kg. We intend to initiate a phase 2 clinical study with ASONEP in 2012. Recent data and scientific literature also suggest that targeting S1P might also have applications in other diseases like multiple sclerosis, colitis and other inflammatory disorders.
Lpath's third product candidate, LpathomabTM is a monoclonal antibody against lysophosphatidic acid (LPA), a key bioactive lipid that has been recognized to be involved in diseases of the central nervous system (including pain, traumatic brain injury, neurodegeneration), fibrosis, ocular disease and cancer. Lpathomab has demonstrated strong preclinical activity in several animal models of these diseases, including neuropathic pain, diabetic neuropathy, traumatic brain injury, spinal cord injury, fibrosis (pulmonary and renal), and cancer.
Lpath's unique ability to generate antibodies against bioactive lipids is based on its proprietary ImmuneY2TMdrug-discovery engine. The company is currently applying the ImmuneY2™ technology to other important bioactive lipid targets, many of which are involved in important disease processes (e.g. inflammation, cancer, pain, asthma, sepsis and others) thereby adding to our pipeline of novel antibody-based drug candidates.
Lpath has a broad and deep intellectual-property position in the lysolipid signaling area, with over 100 issued or pending patents in the U.S., with corresponding international applications. Most of these patents were developed in-house using our proprietary technologies and expertise.