Lpath is halting two mid-state trials with iSONEP until it resolves issues that FDA noticed with cGMP. The Phase II studies included Nexus in wet age-related macular degeneration (AMD) and PEDigree in retinal pigmented epithelial (RPE) detachment. Both were at the patient-dosing stage.
FDA found that the company's fill/finish contractor, Formatech, was not in compliance with cGMP requirements during the period that the iSONEP clinical vials were filled. Lpath notes that even though it believes it took the appropriate steps to oversee Formatech's manufacturing, it has suspended dosing.
Lpath reports that it has initiated the process to manufacture additional drug substance and has identified an alternate fill/finish contractor. Lpath plans to resume dosing in both clinical trials within four to six months subject to any necessary regulatory approvals. The FDA has agreed to respond within 30 days upon Lpath's request to reinstate dosing.
Generated via Lpath's ImmuneY2™ drug discovery platform, iSONEP is a humanized mAb that binds and neutralizes the bioactive lipid, sphingosine-1-phosphate (S1P). The drug is partnered with Pfizer. In December 2010, Pfizer paid Lpath $14 million up front for the option to license the candidate post Phase II trials in AMD and RPE detachment. If Pfizer exercises its option, Lpath will be eligible to receive development, regulatory, and commercial milestone payments that could total up to $497.5 million plus double-digit royalties.