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news.Lpath, a provider of lipidomics-based therapeutic, has submitted an investigational new drug application to the FDA for iSONEP.
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This drug candidate is the ocular formulation of sonepcizumab, a humanized monoclonal antibody against sphingosine-1-phosphate. The company expects to begin Phase I clinical trials of iSONEP as a treatment for age-related macular degeneration (AMD) early in the third quarter of 2008.
Although Lpath will conduct its Phase I for iSONEP in ‘wet’ AMD patients, the company considers iSONEP a potential treatment for a broad range of ocular diseases that extend well beyond wet AMD.
Scott Pancoast, president and CEO of Lpath, said: “This investigational new drug (IND) is a significant achievement for our organization. Submission of the iSONEP IND package less than four months after the submission of the IND for our first drug candidate, ASONEP, underlines the strength of our drug discovery and development programs.”