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LPath resumes dosing of iSONEP in the Phase II Nexus trial for wet AMD following lift of FDA clinical hold

LPath, Inc (OTCBB:LPTN, San Diego, USA), a lipid based antibody therapeutics company, has resumed dosing of their ocular formulation of the humanized monoclonal anti-S1P antibody, “iSONEP”. The drug, which binds to and neutralizes the bioactive lipid, sphingosine-1-phosphate, or S1P, had being under-going testing in two human clinical trials, a Phase1b “PEDigree” trial to treat pigmented epithelial detachment and a Phase IIa “Nexus” trial to treat wet age related macular degeneration (AMD). However, a clinical hold by the FDA suspended testing in January 2012 due to a finding that LPath’s fill/finish contractor, did not meet current Good Manufacturing Practices (cGMP). The company subsequently changed contractor and, on August 27th, Lpath announced the resumption of the Nexus trial however the PEDigree study will not be progressed due to “funding and other decision factors.”