OHR Pharmaceutical Inc (NASDAQ:OHRP), a clinical-stage biotechnology company developing novel therapies for ophthalmic diseases, announced that the first patient has been enrolled in the first Phase III clinical trial of its lead drug candidate squalamine lactate ophthalmic solution, 0.2% (“Squalamine”, also known as OHR-102), for the treatment of neovascular age-related macular degeneration (wet AMD).
“The Phase III clinical program will examine the potential of Squalamine, when administered as part of a combination therapy, to significantly improve visual acuity in patients with wet AMD,” said Dr. Jason Slakter, CEO of Ohr. “We are focused on successfully executing the trials in an expeditious manner. The Phase III program is designed to provide the data required for regulatory approval in major ophthalmic markets worldwide.”
The first of two randomized, double-masked, placebo-controlled trials will include approximately 165 centers in the United States and Canada with a target enrollment of 650 treatment naïve subjects with wet AMD. In March 2016, Ohr reached an agreement on a Special Protocol Assessment (SPA) with the U.S Food and Drug Administration (FDA).
Phase III Clinical Program Design:
The comprehensive Phase III clinical program will be comprised of double-masked, placebo-controlled, multicenter, international studies of squalamine lactate ophthalmic solution, 0.2%, (“Squalamine”, also known as OHR-102) administered twice a day in subjects with newly diagnosed wet AMD, in combination with Lucentis® injections. The primary endpoint will be a measurement of visual acuity gains at nine months, with subjects followed to two years for safety. The eligibility criteria will include subjects with choroidal neovascularization (CNV) secondary to AMD. The lesions in these subjects may contain classic and/or occult CNV, provided the occult CNV component of these lesions measures less than 10mm2 as assessed on fluorescein angiography. (Original Source)
Shares of OHR Pharmaceutical closed last Friday at $3.55, up $0.11 or 3.20%. OHRP has a 1-year high of $6.56 and a 1-year low of $2.02. The stock’s 50-day moving average is $3.35 and its 200-day moving average is $3.69.
On the ratings front, Brean Capital analyst Jonathan Aschoff reiterated a Buy rating on OHRP, with a price target of $30, in a report issued on March 28. The current price target represents a potential upside of 745.1% from where the stock is currently trading. According to TipRanks.com, Aschoff has a yearly average return of -8.7%, a 38.6% success rate, and is ranked #3747 out of 3795 analysts.
Ohr Pharmaceutical, Inc. is a pharmaceutical company, which focuses on the development of novel pharmaceuticals for the treatment of serious and unmet medical needs. The company products include Squalamine eye drops for the treatment of the wet form of age-related macular degeneration (wet AMD) with a potential for expansion into other indications such as diabetic macular edema (DME) and retinal vein occlusions (RVO) and OHR/AVR 118 for the treatment of Cancer Cachexia. Ohr Pharmaceutical was founded by Irach B. Taraporewala in 2008 and is headquartered in New York, NY.