BioDioem eyes vision drug market

Melbourne biopharma BioDiem (ASX:BDM) has entered the race to develop a treatment for the ophthalmic disorder, age-related macular degeneration (AMD), by taking a licence for a Russian-developed peptide therapeutic that has shown high promise in an Australian clinical trial.

BioDiem announced this week it will pay US$500,000 for a licence for its lead compound, designated BDM-E, which came out of the St Petersburg Institute of Bioregulation and Gerontology.

In pre-clinical, in vitro trial at Sydney University's Save Sight Institute (SSI) have confirmed pre-clinical findings by Russian researchers that BDM-E produces beneficial changes in the specialised cells that synthesise the light-capturing pigments of retina.

SSI researchers also reported that the peptide appears to inhibit the proliferation of blood capillaries that overgrow the light-sensing of the retina in AMD and diabetic retinopathy.

Age-related macular degeneration is an increasing problem with the "greying" of populations in developed nations. The disease, which typically after age 50, causes progressive degeneration of the central, or macular region of the retina - essential for the eye to focus on objects in the central visual field - resulting in severe vision loss.

As recently as five years ago, vision researchers regarded both AMD and diabetic retinopathy as untreatable. Current treatments are minimally beneficial, but several different therapeutic prospects have emerged recently from pharmacology and molecular genetics research.

If BioDiem's Russian peptide fulfils its promise and makes it through clinical trials, it could end up eyeball-to-eyeball with one of the world's first RNA-interference (RNAi) therapeutic molecules, developed by US-based Acuity Pharmaceuticals, which silences the gene for vascular endothelial growth factor (VEGF).

The company that likely to be first into the marketplace with an effective new treatment for AMD and diabetic retinopathy is US-based Eyetech Pharmaceuticals.

Eyetech recently entered a collaborative agreement with giant pharma Pfizer to develop its lead compound Macugen. Macugen, which is believed to block the receptor for VEGF, has been fast-tracked by the US Food and Drug Administration.

BioDiem's CEO, Tom Williams, said Associate Professor Mark Gillies team at SSI has shown that BDM-E causes a proliferation of human retinal pigmented epithelial (hRPE) cells, which degenerate in AMD. These cells are the source of the visual pigments for the retina's photoreceptor cells.

The peptide also appears to inhibit proliferation of human choroidal endothelial (hCE) cells, whose excessive growth occludes the retina in AMD. The SSI experiments indicate it has anti-mitogenic (cell-division) mode of action in hCE cells, probably via a role as an antagonist of VEGF.

Wiliams said it was this unique combination of actions that convinced BioDiem to license the drug from the St Petersburg Institute. The company now plans BDM-E in animal models, and to conduct other pre-clinical trials to assess its potential as a treatment for both AMD and diabetic retinopathy.

BioDiem is currently languishing at a share price of $0.60, below its February IPO price of $1.25.

If BDM-E prooves its efficacy, BioDiem could capitalise on the strong competition looming in the AMD-diabetic retinopathy therapeutic market.

BioDiem's commercial strategy is to develop and commercialise its portfolio of compounds through partnerships with international pharmaceutical companies.