Disappointing results from the Regeneron phase 2 and Ophthotech phase 3 wet AMD combination studies have given Ohr Pharmaceutical reason to pause. The company announced that it is “pausing” enrollment in its much-anticipated study of topical squalamine in combination with ranibizumab injections (Lucentis; Genentech) for wet AMD.
On a conference call, Ohr CEO Jason Slakter, MD, cited strategic reasons for this move. The company will gather data on the over 200 patients already enrolled, which will enable the release of efficacy data by late 2017, a year earlier than originally planned. Dr. Slakter said that although results from the recent combination studies had created a negative landscape, squalamine differs from the drugs in those studies in its activity, method of administration, patient selection, and previous trial results.
Specifically, he noted that the aminosterol squalamine is administered topically while the drugs in the other trials are administered via intravitreal injection. He also asserted that the patient population selected for the squalamine phase 3 study was identified in the phase 2 trial as those most likely to benefit from combination therapy, was consistent with the mechanism of squalamine and combination therapy in general, and that squalamine’s biologic activity in the back of the eye had been confirmed by the phase 2 trial. He emphasized that no safety issues were involved in this decision and that Ohr continues to hold discussions with potential partners.
In addition to obtaining clinical data a year early, Dr. Slakter said, the new timetable with a smaller group of patients would also “conserve company resources.”
Ohr reported having $13.5 million in cash in mid-February.
In making the decision to pause trial enrollment, Ohr is hoping to report positive clinical data late this year that would be compelling enough to attract a partner if one has not already signed on. Although there is a risk is that the pause will delay the completion of the phase 3 registration program, Dr. Slakter stated that the overall timeline to regulatory approval will not be affected by this new plan.
On a conference call, Ohr CEO Jason Slakter, MD, cited strategic reasons for this move. The company will gather data on the over 200 patients already enrolled, which will enable the release of efficacy data by late 2017, a year earlier than originally planned. Dr. Slakter said that although results from the recent combination studies had created a negative landscape, squalamine differs from the drugs in those studies in its activity, method of administration, patient selection, and previous trial results.
Specifically, he noted that the aminosterol squalamine is administered topically while the drugs in the other trials are administered via intravitreal injection. He also asserted that the patient population selected for the squalamine phase 3 study was identified in the phase 2 trial as those most likely to benefit from combination therapy, was consistent with the mechanism of squalamine and combination therapy in general, and that squalamine’s biologic activity in the back of the eye had been confirmed by the phase 2 trial. He emphasized that no safety issues were involved in this decision and that Ohr continues to hold discussions with potential partners.
In addition to obtaining clinical data a year early, Dr. Slakter said, the new timetable with a smaller group of patients would also “conserve company resources.”
Ohr reported having $13.5 million in cash in mid-February.
In making the decision to pause trial enrollment, Ohr is hoping to report positive clinical data late this year that would be compelling enough to attract a partner if one has not already signed on. Although there is a risk is that the pause will delay the completion of the phase 3 registration program, Dr. Slakter stated that the overall timeline to regulatory approval will not be affected by this new plan.
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