Source: Bruce V. Bigelow, Xconomy.com
A San Diego biopharmaceutical startup, formed just five months ago to resume development of a compound for treating age-related macular degeneration, has reported encouraging results from a two-year, mid-stage clinical trial of the compound, known as fenretinide.
The findings were released in Florida yesterday at the annual meeting of the American Society of Retinal Specialists and in San Diego today by ReVision Therapeutics, the biotech started in April with venture funding led by Avalon Ventures, which was joined by Advent Healthcare, Aisling Capital, Atlas Capital, Investor Growth Capital, and Novaquest. (The biopharmaceutical startup is not to be confused with Rhevision Technology, another San Diego startup with a similar name that is developing miniature tunable camera lenses for mobile phone handsets.)
Avalon’s Jay Lichter declined to say this afternoon how much capital ReVision has raised to acquire fenretinide and to restart development of the drug in San Diego. He would only say that ReVision now has ample resources to analyze the data accumulated on fenretinide so far—and to continue development of the drug as a treatment for macular degeneration, a chronic deterioration of the central portion of the retina. The age-related condition is a leading cause of blindness in people 60 and older, and affects some 1.8 million Americans, according to the National Eye Institute.
The deal to acquire the compound and start ReVision means fenretinide has come full circle. It was initially under development as a potential treatment for macular degeneration by Sytera, a San Diego-based company founded in 2004. But development of the drug moved to Tampa, FL-based Sirion Therapeutics, an ophthalmic-focused biopharmaceutical that acquired fenretinide through its 2006 merger with Sytera. Sirion conducted the mid-stage clinical trials at a number of sites throughout Florida, and Lichter says the last patient left the trial in April.
Sytera was founded to develop fenretinide by Kevin Kinsella, the founder of San Diego-based Avalon Ventures, and Ken Widder (now with Latterell Venture Partners of San Francisco), with help from Avalon’s Lichter, Nathan Mata, and Gabriel Travis, a professor of biochemistry at UCLA. Kinsella, who was on Sirion’s board, and Lichter led the move to bring fenretinide development back to San Diego after the Florida biotech hit the economic doldrums in 2009.
Lichter says fenretinide was originally under development as a potential anti-cancer drug in the 1980s by Johnson & Johnson. That effort was shelved after the compound showed no efficacy as a cancer drug, although those early studies showed what Lichter called “a very good safety record” for the compound that has been used in subsequent studies.
Fenretinide was identified as a possible drug for treating macular degeneration roughly a decade ago, because it interferes with a binding process that helps move retinol, a form of vitamin A, into the eye, according to Lichter. Researchers suspect that toxic byproducts associated with retinol contribute to macular degeneration.
The results of the Phase 2b clinical trials exceeded expectations by showing an unanticipated benefit, according to Lichter. Patients who were given the drug orally once a day showed a lower incidence in the progression of macular degeneration—by more than 50 percent—from an early stage condition known as “dry” AMD (for Age-related Macular Degeneration) to a more serious form known as “wet” AMD.
The trial, which enrolled 246 patients, also showed that fenretinide reduces the growth of lesions that can form on the retina in patients with the most advanced form of dry AMD. Fenretinide also was found to be safe and well tolerated, with no severe drug-related adverse events, and no significant effects on normal vision.