Ohr Pharmaceutical, Inc.’s OHRP shares plunged 68.6% immediately after the company reported disappointing top-line results from an exploratory phase II study (IMPACT) evaluating OHR-102 (0.2% squalamine lactate ophthalmic solution) combination therapy for the treatment of patients suffering from the wet form of age-related macular degeneration (wet-AMD).
In the nine-month phase II study, one treatment arm received OHR-102 drops twice daily plus Roche’s RHHBY Lucentis while patients in the other arm were given placebo eye drops twice daily plus Lucentis.
Results revealed that less of a benefit in the overall population (classic containing and occult only choroidal neovascularization/CNV) was observed. Moreover, the primary endpoint of the study, which was the mean number of injections between the treatment arms, was not found to be meaningfully different.
However, in the intent-to-treat CNV group, patients on OHR-102 achieved a ≥3 line gain (42%; +10.5 letters) as compared to patients in the Lucentis monotherapy group (28%; +5.4 letters) when observed after 9 months of treatment. On the safety front, OHR-102 was found to be well tolerated and 90% of the 142 randomized patients completed the study.
Ohr Pharma intends to present detailed data at the scientific meeting of the Association for Research in Vision and Ophthalmology in May this year. The company believes that the results will help design a phase III program on OHR-102 for the wet-AMD indication.
Currently prescribed treatments for wet AMD include Regeneron’s REGN Eylea.
We are disappointed with the phase II study results considering that OHR-102 is the lead candidate in the company’s pipeline.
Meanwhile, Ohr Pharma is also evaluating OHR-102 for several additional indications including proliferative diabetic retinopathy, branch and central retinal vein occlusion and diabetic macular edema.
Ohr Pharma currently carries a Zacks Rank #2 (Buy). A better-ranked stock in the health care sector is Salix Pharmaceuticals Ltd. SLXP carrying a Zacks Rank #1 (Strong Buy).