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news.Lpath, in consultation with Pfizer, has completed enrollment of its clinical trial evaluating iSONEP in patients with wet age-related macular degeneration (wet AMD), which is also referred to as the Nexus study.
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This multicenter, Phase 2 clinical trial enrolled patients who have not responded well to existing anti-vascular endothelial growth factor (VEGF) therapies including Lucentis®, Avastin® and Eylea®.
Top line study results are expected to be available in the second quarter of 2015. The Nexus Data Safety Monitoring Board (DSMB) continues to express no significant safety concerns with the study treatments and has encouraged Lpath to close enrollment by the end of the year.
"We are eager to advance our lead program to data analysis in order to evaluate proof-of-concept of iSONEP in patients with wet AMD, either as an adjunctive or monotherapy," stated Dario Paggiarino, M.D., senior vice president and chief development officer of Lpath. "We expect the results from the Nexus study will provide additional insights as to whether iSONEP has biologic activity in the multiple mechanisms that underlie wet AMD-related vision loss, in addition to vascular leakage."
The primary endpoint of the Nexus study is a mean change in best corrected visual acuity (BCVA) at 120 days. Secondary endpoints include measurements of retinal thickness, neovascular lesion size and safety, among others.
iSONEP is an antibody that blocks the bioactive lipid sphingosine-1-phosphate (S1P), implicated in choroidal neovascularization, inflammation and fibrosis – all of which are believed to be important factors in the development of wet AMD.
Lpath is also conducting a Phase 2a trial evaluating ASONEP™, an anti-S1P antibody that is formulated for systemic delivery, in patients with metastatic renal cell carcinoma.
Lpath has also utilized its ImmuneY2™ drug discovery engine to produce LpathomabTM (an antibody targeting lysophosphatidic acid, or LPA), for which investigational new drug (IND) enabling studies have been completed.
In addition, Lpath is planning to file an IND application with the United States Food and Drug Administration for Lpathomab for the treatment of neuropathic pain in January 2015 and to initiate a Phase 1 safety study of Lpathomab in the first quarter of 2015.