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news.The US 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.
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Lpathomab is a new antibody targeting Lysophosphatidic Acid (LPA), a bioactive lipid that has been characterized in the scientific literature as playing a major role in nerve injury and neuropathic pain.
The company said that it is compiling a detailed response to the FDA request.
The initial review period for the lpathomab IND application has ended and so the application has been placed on clinical hold as part of the standard FDA procedure.
Following submission of the requested data, the FDA will review it and determine whether the company may proceed with the Phase I clinical trial of lpathomab.
According to the company, it has not started a Phase I clinical trial with this molecule, and that no patient has been recruited or dosed.
Preclinical studies conducted by the company 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, such as diabetic peripheral neuropathy, post-herpetic neuralgia, chemotherapy-induced neuropathic pain and pain associated with lumbosacral radiculopathy.