Lpath to Submit Additional Data for Lpathomab Investigational New Drug Application
SAN DIEGO, March 11, 2015 /PRNewswire/ -- Lpath, Inc. (NASDAQ: LPTN), a leader in the discovery and development of lipid-targeted therapeutics, announced that the U.S. Food and Drug Administration (FDA) has requested additional analysis of certain data submitted as part of Lpath's recently submitted Investigational New Drug (IND) application for Lpathomab™. Lpathomab is a novel 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 is compiling a detailed response to the FDA request. The initial review period for the Lpathomab IND application has ended, therefore it is standard FDA procedure to place the application on clinical hold. After Lpath submits the requested data, the FDA will review it and determine whether Lpath may proceed with the Phase 1 clinical trial of Lpathomab.
It should be noted that Lpath has not initiated a Phase 1 clinical trial with this molecule, and that no patient has been recruited or dosed.
About Lpathomab™
Lpathomab is an internally discovered, first-in-class 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 showed 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.
About Lpath
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 to and inhibit lipids that contribute to disease. The company has developed four drug candidates, two of which—iSONEP for wet AMD and ASONEP for cancer—are currently being investigated in Phase 2 trials. The other candidates are an anti-LPA antibody, Lpathomab, for neuropathic pain and an anti-leukotriene antibody, Altepan, which is being studied in models of inflammatory bowel disease, respiratory disease and inflammation. For more information, visit www.Lpath.com.
Forward-Looking Statements
Lpath cautions you that the statements included in this press release that are not a description of historical facts are forward-looking statements. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in Lpath's business, including, without limitation: Lpath may not be permitted by the FDA to proceed with the Phase 1 clinical trial of Lpathomab on a timely basis, without first being required to conduct additional studies, or at all; the final results of Lpath's preclinical studies and clinical trials may be different from Lpath's studies or interim data results and may not support further clinical development and/or the commercialization of its drug candidates; Lpath may not successfully complete its existing and any additional clinical trials for its drug candidates on a timely basis, or at all; Lpath may fail to obtain required governmental approvals for any of its drug candidates; Lpath may not be successful in maintaining its commercial relationship with Pfizer Inc. or any third party that may acquire the exclusive option Lpath granted to Pfizer for iSONEP; and Lpath may not be able to secure the funds necessary to support its preclinical-development and clinical-development plans. More detailed information about the risk factors and uncertainties that may affect the realization of forward-looking statements is set forth in Lpath's filings with the Securities and Exchange Commission (the "SEC"), including its Annual Report on Form 10-K, its Quarterly Reports on Form 10-Q, and its other filings with the SEC. Such documents may be read free of charge on the SEC's website at www.sec.gov. You are cautioned not to place undue reliance on these forward-looking statements, which are effective only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and Lpath undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
COMPANY CONTACT:
Gary Atkinson
Chief Financial Officer
Lpath, Inc.
858-926-3202
[email protected]
PUBLIC RELATIONS CONTACT:
Canale Communications
Rachel Hutman
619-849-5384
[email protected]
SOURCE Lpath, Inc.
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