A drug targeting a bioactive lipid linked to neuropathic pain is pending FDA approval to begin a phase 1 clinical trial.
An Investigational New Drug (IND) application has been submitted to the US Food and Drug Administration (FDA) to conduct a phase 1 study of Lpathomab which would treat neuropathic pain, according to an Lpath, Inc press release.
The phase 1 study aims to evaluate the safety and tolerability of Lpathomab in neuropathic pain patients and will begin enrolling patients once the FDA’s IND review period is complete. The study is still pending approval by the trial sites’ investigational review boards during this review period.
“We’ve made great progress in advancing Lpathomab towards the clinic and are eager to start our first in human study for our third antibody product candidate produced using our ImmuneY2TM drug discovery engine,” Dario Paggiarino, MD, chief development officer of Lpath, said in a press release. “We believe our approach of targeting the ligand Lysophosphatidic acid (LPA) with an antibody may have distinct mechanistic advantages over traditional small molecule approaches to address an area of significant unmet medical need.”
LPA is a bioactive lipid that previous studies have determined to be linked to nerve injury and neuropathic pain. It was internally discovered as a first in class targeting LPA lipid. In preclinical trials by Lpath in several pain models, Lpathomab showed strong in vivo results. The researchers concluded LPA may be a successful target across a myriad of pain conditions, including diabetic peripheral neuropathy, post herpetic neuralgia, chemotherapy induced neuropathic pain, and pain associated with lumbosacral radiculopathy.
Lpath, which is based in San Diego, California, brands itself as a leader in the discovery and development of lipid targeted therapeutics. The company has previously developed 4 drug candidates, of which 2 are currently being investigated in phase 2 trials for cancer treatment. Lpathomab is currently awaiting FDA IND approval, and Altepan is being studied in models of inflammatory bowel disease, respiratory disease, and inflammation.