Struggling Ohr shutters San Diego lab
- Ohr Pharmaceutical has quietly slipped details of a pre-clinical lab closure and eight immediate job losses out in a filing with the Securities and Exchange Commission. The lab carried out pre-clinical work on the companies sustained release platform technology.
- This followed news in mid-February in the earnings release that the company had paused enrollment of the first Phase 3 trial of its lead compound, squalamine lactate eye drops for wet age-related macular degeneration, to evaluate its efficacy. Ohr also reported a net loss for the second year running.
- Share prices that were already tumbling after the trial pause and earnings news have fallen a further 18% on the news of the lab closure.
Ohr Pharmaceutical has suspended work at its laboratory facility in San Diego, the location responsible for the pre-clinical work on its sustained release platform. This is a hydrogel-based microparticle technology for delivery of drugs to the eye. It's not clear why the company has made this choice, but it may be linked with the recent pause in enrollment in the Phase 3 trial of the company's lead drug squalamine lactate eye drops in in wet age-related macular degeneration (wet-AMD). The drug is being given in combination with Lucentis (ranibizumab) injections. Ohr has stated that the enrollment pause is not related to any safety issue.
"We plan to continue the study for currently enrolled patients to evaluate the efficacy of squalamine combination therapy," said Ohr CEO Jason Slakter. "This approach is intended to provide prospective efficacy data before year end 2017 to enable us to potentially confirm the visual acuity benefits observed in the patient population we identified as the most likely to benefit from squalamine combination therapy. Given the recent study readouts from other combination therapy agents and the reaction to these results, we feel that a change in our clinical development program is warranted."
Ohr Pharmaceutical's squalamine lactate eyedrops, also known as OHR-102, have already stumbled in clinical development. In 2015, when Ohr announced topline Phase 2 results in wet AMD, the results were clinically significant within a subset of patients with choroidal neovascularization (CNV), with less of a benefit for the wet-AMD population overall.
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