Lpath Presents Positive Results On Asonep

The study results included demonstration that lymphocyte counts in the vascular space were reduced in a dose-related fashion. As such, Lpath achieved an objective established by Merck KGaA (Darmstadt, Germany) and received a $2m payment according to the terms of Lpath’s license agreement with Merck KGaA.

Lpath said that the summary results also show that the Phase 1 trial met its primary endpoint of identifying safe dose levels for investigation in the Phase 2 setting. Asonep was well tolerated at all the dose-levels studied, which ranged from 1 mg/kg to 24 mg/kg. More than half the patients that completed the initial four-treatment evaluation period showed stable disease. Durable stable disease was observed in several patients.

Michael Gordon, principal investigator of Phase 1 trial, said: “These Phase 1 results with Asonep are encouraging. The safety of Asonep as demonstrated in this study allows for its evaluation as a single agent or in combination with standard therapies without expectation of significant overlapping toxicities. This safety profile, along with the observation of stable disease in several late-stage cancer patients, provides strong justification for investigation of Asonep in Phase 2 clinical trials.”

Scott Pancoast, president and CEO of Lpath, said: “Our Phase 1 trial further validates our novel approach of targeting bioactive signaling lipids and underscores the potential of our ImmuneY2(TM) drug-discovery engine. Moreover, achievement of the milestone provides evidence that Asonep is having the expected pharmacological effect in human subjects, which is important with a first-in-class drug candidate.”