BDM-E: A solution for niche eye diseases
BDM-E was discovered in Russia, and has been successfully used in some Russian clinics for the compassionate treatment of eye disorders including Retinitis Pigmentosa (RP). RP is a serious eye disease that causes progressive degeneration of the delicate light receptor cells in the retina, which over time diminishes night and peripheral vision and eventually leads to blindness. This condition affects between an estimated one in 3,000 to one in 5,000 people, equivalent to approximately 100,000 to 120,000 people in the U.S. alone, and 2–2.5 million people worldwide. Currently there is only one therapy, vitamin A supplementation, which can benefit a subgroup of people with retinitis pigmentosa by slowing progression of disease. There are no therapies, however, that can prevent retinal degeneration or restore vision loss.
In September 2010 BioDiem received Orphan Drug designation from the United States Food and Drug Administration (FDA) for BDM-E for the treatment of Retinitis Pigmentosa.
BioDiem’s preclinical work in Retinitis Pigmentosa has demonstrated promise. In vivo studies have shown that BDM-E is able to reduce the degree of damage to the retinal cell layers. It has also been shown to exert a degree of protection over the retina in models of this disease. In another research model of light damage it prevented photoreceptor apoptosis (programmed cell death). Through the use of BDM-E in Russia and results of an earlier clinical trial, BDM-E has already shown a good safety profile in the dose administered.
Preclinical studies at Monash University and the University of Melbourne have demonstrated that BDM-E produces positive effects in retinopathy of prematurity, a model of eye disease. These studies have been extended to other laboratory eye disease models such as diabetic retinopathy and age-related macular degeneration. Supported by this work, the company has submitted a new provisional patent covering BDM-E analogues. This will further strengthen the patent position of BDM-E and enhance its attractiveness for out licensing or a sale in line with BioDiem’s strategy for this asset. The research results were presented in July 2012 at the International Society of Eye Research (ISER) meeting in Berlin, Germany.
In May 2012, BioDiem announced a research agreement with the Foundation Fighting Blindness (FFB) in the United States. This further preclinical work is being conducted at the Kearn Family Center for the study of Retinal Degeneration, headed by Dr. Matthew LaVail at the University of California, San Francisco, and is testing BDM-E in a model of the inherited degenerative eye disorder RP. The study will help to evaluate the potential of BDM-E to treat retinitis pigmentosa and the spectrum of RP-like diseases in humans.
BioDiem’s strategy for BDM-E is to finalise its data package in preparation for sale or outlicensing. The strategic focus on vaccines and therapies for infectious diseases and specific cancers has meant the most appropriate way for BioDiem to extract value from BDM-E is via a high-value divestment. The current preclinical program with the FFB is in aid of this objective.