Lpath, Inc., the industry leader in lipidomics-based antibody therapeutics, has temporarily suspended dosing patients in its PEDigree and Nexus trials. In these trials, iSONEP™ is being tested as a treatment for wet AMD (Nexus) and a related complication called Pigmented Epithelial Detachment (PEDigree).
The company has taken this action because it learned from the FDA that the company's fill/finish contractor, Formatech, Inc., was not in compliance with FDA's current Good Manufacturing Practice (cGMP) requirements during the period that the iSONEP clinical vials were filled. Accordingly, even though Lpath believes it has taken appropriate steps to oversee Formatech's manufacturing in order to ensure product quality, it has suspended dosing as a precaution to ensure the continued safety of all patients in its clinical trials.
iSONEP was well tolerated by all patients in the Phase 1 trial and by all patients thus far in the PEDigree and Nexus trials. The company has received no claims raising safety concerns regarding iSONEP.
Lpath 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.
Scott Pancoast, Lpath's president and chief executive officer, commented: "While we are disappointed to learn about these FDA concerns, we believe this issue does not affect the prospects for value creation by our PEDigree and Nexus studies."
"We continue to expect that the resolution of RPE detachments that we saw in each of the two patients in our Phase 1 trial will be repeated in our PEDigree study, and that the significant reductions in lesion size that we also saw in the Phase 1 trial will be repeated in the Nexus study," added Pancoast.