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news.The US Food and Drug Administration (FDA) has completed the review of an investigational new drug (IND) application for Lpath's lpathomab, an antibody targeting lysophosphatidic acid (LPA), and informed the company to initiate a Phase I clinical trial to evaluate the antibody.
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The company intends to start the trial upon investigational review board approvals and expects the first subject to be dosed within two months.
LPA is a bioactive lipid that has been characterized in the scientific literature as playing a key role in nerve injury and neuropathic pain.
Preclinical trials of the company have shown strong in vivo results with lpathomab in several different pain models.
The results 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 trials have also showed the potential for lpathomab as a treatment for traumatic brain injury, and preclinical studies for this indication are currently underway in conjunction with the US Department of Defense at Walter Reed Army Institute of Research as well as at academic institutions.
Apart from advancing lpathomab into the clinic, the company intends to generate in vivo data in select programs, including Altepan and other earlier stage preclinical candidates, in order to identify its next clinical candidates and indications to pursue.
Lpath board of directors chairman Daniel Petree said: "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."
Simultaneously, the company will actively explore partnering, licensing and monetization options for its pipeline assets.