BioTuesdays - All eyes on Ohr Pharma wet AMD study
Even though Ohr Pharmaceutical (OTCBB:OHRP) will be releasing results, in the current quarter, of a Phase 2 clinical trial in patients with cancer cachexia, all eyes are on a Phase 2 study of its squalamine eye drop to treat wet age-related macular degeneration (AMD), with interim results due at the end of the year.
“We have had quite a bit of interest in partnering our OHR/AVR 118 drug candidate for cancer cachexia, and we will look to license out the program after Phase 2, because the company’s core focus is now ophthalmology and bringing second-generation products through the pipeline,” CEO Irach Taraporewala says in an interview with ........
"After the acquisition, Ohr reformulated squalamine, which is protected by several patents through 2029, into a twice-daily, self-administered eye drop. The company also has a family of patent applications filed on new formulations of squalamine, which would extend patent protection.
Dr. Taraporewala points out that an eye drop solves many problems associated with intravenous delivery, including: suboptimal dosing; 40-minute weekly infusions, which are difficult for elderly patients; and commercial challenges arising from ophthalmologist offices not being set up for large-scale prolonged infusions.
AMD is a major cause of vision loss in people over the age of 50. Wet AMD begins when abnormal blood vessels (neovascularization) leak fluid and blood at the back of the eye, with scars that can rapidly damage the macula and cause loss of central vision.
The global market for wet AMD therapies is currently worth about $4-billion a year and is growing briskly. There are now some 1.75 million patients in the U.S., with 200,000 new cases each year. The market is dominated by intravitreal injections into the eye every month or two, with Roche/Genentech’s Lucentis as the market leader, followed by Regeneron’s Eylea and off-label use of Roche’s Avastin.
In an initiation report last November, Burrill Merchant Banking analyst, Elemer Piros, said that squalamine’s potential to provide an effective topical therapy for wet AMD “could revolutionize the current care of the disease” and “capture a significant share of the market.”
In addition to a superior delivery method, Dr. Taraporewala explains that squalamine inhibits neovascularization by blocking multiple protein growth factors of angiogenesis, including vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF) and basic fibroblast growth factor growth factor (bFGF). It has this ability through the unique intracellular mechanism of squalamine."