Ohr Pharma's OHR-102 Fails in Phase II, Shares Plunge
Published: Mar 30, 2015
March 27, 2015
By Krystle Vermes, BioSpace.com Breaking News Staff
New York-based Ohr Pharmaceutical released results from its Phase II IMPACT study today, which evaluated OHR-102 for the treatment of the wet form of age-related macular degeneration. The treatment failed to achieve its primary endpoint, and shares of the company are now down more than 60 percent.
OHR-102, a 0.2 percent squalamine lactate ophthalmic solution, is a combination therapy for back-of-the-eye diseases. IMPACT was designed to compare OHR-102 to Lucentis monotherapy in patients with wet-AMD. One group of patients received OHR-102 eye drops twice a day plus Lucentis PRN, while another group received Lucentis PRN and placebo eye drops.
The study results showed that there was not a significant difference in the benefit in the overall population of participants.
However, the researchers found that 42 percent of patients receiving OHR-102 achieved a 3-line gain at nine months, compared to 28 percent of those receiving Lucentis. Additionally, the positive effect on visual acuity in classic containing choroidal neovascularization persisted throughout the trial.
"Now that the full data from the Phase II study is available, we are thoroughly evaluating all of the underlying factors that may have contributed to variability in patient response,” said Jason Slakter, chief medical officer of Ohr Pharmaceutical. “These analyses will help guide and optimize the design of the Phase III trials of OHR-102 in wet-AMD."
The Search for Ocular Disease Treatments
At the beginning of March, Ohr Pharmaceutical presented information from the ongoing Phase II trial at the 38th Annual Macula Society Meeting in Arizona. At the time, the company had a positive outlook based on interim data that showed that OHR-102 could provide improvement in visual acuity.
The information presented at the Macula Society Meeting showed that in a masked analysis of spectral domain optical coherence tomography images, the reduction in sub-retinal hyper-reflective material occurred early in IMPACT.
However, the results released by Ohr Pharmaceutical today indicate that there is still room for improvement as trials roll on.
Squalamine, the active ingredient in OHR-102, is one of Ohr Pharmaceutical’s leading products. It is a first-in-class small molecule anti-angiogenic drug. It works by preventing the development of aberrant neovascularization. Squalamine inhibits multiple protein growth factors of angiogenesis, including the vascular endothelial growth factor.
The Phase II trial for squalamine eye drops reached 50 percent enrollment in July 2013. Ohr Pharmaceutical continues to look at the product as a viable treatment option for patients with wet-AMD, as well as diabetic macular edema.
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