SAN DIEGO, July 23, 2015 /PRNewswire/ -- Lpath, Inc. (NASDAQ: LPTN), the industry leader in bioactive lipid-targeted therapeutics, announced that the U.S. Food and Drug Administration (FDA) has completed its review of the Investigational New Drug Application (IND) for Lpathomab™. The FDA informed the company that the Phase 1 clinical trial to study Lpathomab may now be initiated. Lpath plans to begin this trial upon investigational review board approvals and anticipates the first subject to be dosed within two months.
Lpathomab is an antibody targeting lysophosphatidic acid, or LPA, a bioactive lipid that has been characterized in the scientific literature as playing a key role in nerve injury and neuropathic pain. Lpath's preclinical studies have shown strong in vivo results with Lpathomab in several different pain models, which suggest that LPA may be an attractive target across a variety of chronic pain conditions, including diabetic peripheral neuropathy, post-herpetic neuralgia, chemotherapy-induced neuropathic pain and pain associated with lumbosacral radiculopathy. Other preclinical studies have also demonstrated the potential for Lpathomab as a treatment for traumatic brain injury, and preclinical studies for this indication are currently underway in conjunction with the U.S. Department of Defense at Walter Reed Army Institute of Research as well as at academic institutions.
In addition to advancing Lpathomab into the clinic, Lpath intends to generate in vivo data in select programs, including Altepan™ and other earlier stage preclinical candidates, in order to identify the company's next clinical candidates and indications to pursue. Simultaneously, Lpath will actively explore partnering, licensing and monetization options for its pipeline assets. Lpath's proprietary discovery platform continues to be effective at creating bioactive lipid-targeted monoclonal antibody therapeutics. By reprioritizing its research and development programs, Lpath will continue to advance its discovery science and its pipeline assets.
Lpath's Altepan program continues to make progress and has now shown positive results in preclinical models of pulmonary fibrosis, asthma, inflammatory bowel disease, and other indications. Altepan is a monoclonal antibody targeting members of the cysteinyl leukotriene family, which are important mediators of inflammatory disorders. Altepan is ready to begin IND-enabling development activities to prepare for an IND submission to the FDA as soon as funding is available.
Daniel Petree, chairman of the Lpath board of directors, commented: "We have built a differentiated discovery technology that we believe has significant promise to generate first-in-class therapeutics, and from which we have generated a pipeline of clinical assets that have been well tolerated and have demonstrated signals of efficacy. We now plan to focus our resources and efforts on advancing Lpath's highest-value assets – Lpathomab and Altepan – and drive toward the next achievable value inflection and decision points. Investing selectively in these earlier-stage programs and seeking collaborators with capabilities and resources that exceed our current resources is the best way to realize value for our shareholders and our company. With these revised priorities, our existing cash should be sufficient to fund the company's drug discovery and development activities at least through June 30, 2016."
Lpath's relationship with Pfizer, its partner on the iSONEP wet AMD program, remains cooperative. All of the required Nexus trial data was delivered to Pfizer in late May. Pfizer has not communicated to Lpath when they will make a decision on the iSONEP option, or what that decision may be. However, based on the negative results of the Nexus trial, Lpath believes it is unlikely that Pfizer will exercise the option for a worldwide license to iSONEP. If Pfizer does not exercise the option, Lpath does not plan to conduct any further clinical trials of iSONEP.
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 four drug candidates, 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.
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 for its drug candidates, the potential therapeutic uses and benefits of Lpathomab and the Company's other drug candidates and the timing for the Company to commence the Lpathomab clinical trial. 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 final results of the Company's preclinical studies and clinical trials may be different from the Company's studies or interim 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; the Company may fail to obtain required governmental approvals for any of its drug candidates; the Company may not be successful in maintaining its commercial relationship with Pfizer Inc.; and the Company may not be able to secure the funds necessary to support its preclinical-development and clinical-development plans. 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 24, 2015 and its Quarterly Report on Form 10-Q filed with the SEC on May 8, 2015. 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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