Pharmaceutical Business review

Lpath seeks FDA approval to begin Phase I trial of pain drug lpathomab

The trial’s primary objective is to evaluate the safety and tolerability of Lpathomab in subjects that are experiencing neuropathic pain.

Patient enrollment is expected to start once the FDA’s IND review period is complete and the trial study has been approved by the trial sites’ investigational review boards.

Lpathomab is an antibody targeting Lysophosphatidic Acid (LPA), a bioactive lipid that has been characterised in the scientific literature as playing a major role in nerve injury and neuropathic pain.

Preclinical studies carried out by the company showed strong in vivo results with Lpathomab in several different pain models.

The trials 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.

Lpath chief development officer Dario Paggiarino said: "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.

"We believe our approach of targeting the ligand (LPA) with an antibody may have distinct mechanistic advantages over traditional small molecule approaches to address an area of significant unmet medical need."