Brief Overview
Lpath, Inc., headquartered in San Diego, is the category leader in lipid-based therapeutics, an emerging field of medical science whereby bioactive signaling lipids are targeted for treating important human diseases.
Lpath's lead product candidate, ASONEP™ (the systemic formulation of humanized Sphingomab™), is a monoclonal antibody against a validated cancer target, sphingosine-1-phosphate (S1P), that has completed enrollment in a phase I clinical trial in cancer patients, where it was deemed well tolerated at dose levels up to 24 mg/kg. ASONEP™ is potently anti-angiogenic, yet it has other mechanisms of action that may prove advantageous in the clinical setting. As such, Lpath believes ASONEP™ may represent the next generation of anti-angiogenesis-based therapeutics. In October 2008, Lpath and Merck Serono, a division of Merck KGaA, entered into a worldwide alliance to develop and commercialize ASONEP in a partnership valued at up to $473M.
Lpath's second product candidate, iSONEP™ (the ocular formulation of humanized Sphingomab™), has completed a phase I clinical 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 effects of 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.
Lpath's third product candidate, Lpathomab™, is a monoclonal antibody against lysophosphatidic acid (LPA), a key bioactive lipid that has long been recognized as a significant promoter of cancer-cell growth and metastasis, fibrosis and neuropathic pain. Lpathomab has demonstrated strong preclinical activity in several animal models of these diseases.
Lpath's unique ability to generate antibodies against bioactive lipids is based on its proprietary ImmuneY2™ drug-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 35 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.