US-based Lpath has completed patient enrolment in its Phase II clinical trial (Nexus) of iSONEP, an antibody designed to treat wet age-related macular degeneration (wet AMD).
iSONEP blocks the bioactive lipid sphingosine-1-phosphate (S1P), implicated in choroidal neovascularisation, inflammation and fibrosis, which are major factors in the development of wet AMD.
The trial enrolled patients who have not responded well to existing anti-vascular endothelial growth factor (VEGF) therapies including Lucentis, Avastin and Eylea.
Top line results from the multicentre Phase II trial are expected to be available in the second quarter of 2015.
According to the Nexus Data Safety Monitoring Board (DSMB), there were no significant safety concerns with the trial treatments.
Lpath senior vice-president and chief development officer Dario Paggiarino said: "We are eager to advance our lead programme to data analysis in order to evaluate proof-of-concept of iSONEP in patients with wet AMD, either as an adjunctive or monotherapy.
"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 trial’s primary endpoint is a mean change in best corrected visual acuity (BCVA) at 120 days, while secondary endpoints include measurements of retinal thickness, neovascular lesion size and safety, among others.
The company is also conducting a Phase IIa trial evaluating ASONEP, an anti-S1P antibody that is formulated for systemic delivery, in patients with metastatic renal cell carcinoma.
Lpath has used its ImmuneY2 drug discovery engine to produce Lpathomab, for which investigational new drug (IND) enabling trails have been completed.
Additionally, the company is planning to file an IND application in January 2015 with the US Food and Drug Administration (FDA) for Lpathomab (an antibody targeting lysophosphatidic acid, or LPA) to treat neuropathic pain and to start a Phase I safety trial of Lpathomab in the first quarter of 2015.