SAN DIEGO, April 19, 2016 /PRNewswire/ -- Lpath, Inc. (NASDAQ: LPTN), the industry leader in bioactive lipid-targeted therapeutics, announced today completion of its Phase 1 double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, immunogenicity and pharmacokinetics of Lpathomab™ in healthy volunteers. Lpathomab was well tolerated at all doses tested, and no serious adverse events or dose limiting toxicities were observed.
Lpathomab was administered in five different ascending dose cohorts at 0.5, 1.0, 3.0, 10.0 and 20.0 mg/kg. Study follow-up was completed after dosing with a single intravenous infusion in 36 subjects as planned. The pharmacokinetic profile of Lpathomab suggests the half-life of the antibody is in the range of 14-18 days, which gives guidance for dosing and treatment regimens in future efficacy studies. Lpath is actively exploring collaboration opportunities for Lpathomab and anticipates that any subsequent clinical studies will be conducted with a partner.
"We are very pleased that in this first-in-human study of Lpathomab we observed not only acceptable safety and tolerability at doses as high as 20 mg/kg, but also a favorable pharmacokinetic profile that could support a variety of dosing regimens in neuropathic pain trials," commented Dario Paggiarino, M.D., Lpath's senior vice president and chief development officer.
Lpathomab is a first-in-class, humanized monoclonal antibody targeting lysophosphatidic acid (LPA), and has shown positive activity in animal models of neuropathic pain induced by a variety of conditions, including nerve injury, type 1 and 2 diabetes, inflammation, and chemotherapeutic administration. Lpathomab was discovered using Lpath's internal drug-discovery engine and antibodies developed via this discovery engine are designed to target bioactive signaling lipids that are involved in neuropathic pain, neurotrauma, cancer, inflammatory disorders and many other diseases.
San Diego-based Lpath, Inc. (NASDAQ: LPTN) is the category leader in lipid-targeted therapeutics. The company's ImmuneY2™ drug-discovery engine has the unique ability to generate therapeutic antibodies that bind and inhibit bioactive lipids that contribute to disease. The company has developed three drug candidates, has advanced the first two to mid-stage trials and built evidence to support its approach of targeting bioactive lipids to treat a wide range of diseases. For more information, visit www.lpath.com.
About Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These forward-looking statements include but are not limited to, statements regarding the Company's development plans, potential therapeutic uses for its drug candidates, including Lpathomab, and the timing and ability of the Company to commence further clinical trials of its drug candidates. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in the Company's business, including, without limitation: the Company may be unable to complete a strategic transaction or otherwise secure the funds necessary to support its future operations or its preclinical-development and clinical-development plans, on a timely basis or at all; the final results of the Company's preclinical studies and clinical trials may be different from the Company's studies or interim clinical data results and may not support further clinical development and/or the commercialization of its drug candidates; the Company may not successfully complete its existing and any additional clinical trials for its drug candidates on a timely basis, or at all; and the Company may fail to obtain required governmental approvals for any of its drug candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K filed with the SEC on March 22, 2016. Such documents may be read free of charge on the SEC's web site at www.sec.gov. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and the Company undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
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