LPath, Inc (OTCBB:LPTN, San Diego, USA), one of the world leaders in lipid based antibody therapeutics, has temporally suspended dosing in two clinical trials involving their ocular formulation of the humanized monoclonal anti-S1P antibody, known as “iSONEP”. The drug, which binds to and neutralizes the bioactive lipid, sphingosine-1-phosphate, or S1P, was being tested in two human clinical trials, a Phase1b “PEDigree” trial to treat pigmented epithelial detachment and a Phase 2a “Nexus” trial to treat wet age related macular degeneration (AMD). The company announced temporary suspension of dosing due to a finding by the FDA that LPath’s fill/finish contractor, Formatech Inc (Andover, Massachusetts), did not meet current Good Manufacturing Practices (cGMP). The company emphasized that there were no reports of safety concerns and that they had already identified an alternative fill/finish contractor to allow them resume dosing in both clinical studies within 4-6 months. LPath’s share price dropped 23% following news of the suspension and was 20% down on the week.
LPath suspends dosing in two ophthalmic clinical trials following report on compliance issues from FDA
- by swdadmin