Ohr’s Squalamine Combination Therapy Fails in Phase III Trial in Wet AMD

January 12, 2018: By Joan McKenna

Ohr Pharmaceutical announced Jan. 5 that squalamine used in combination with Lucentis failed to meet its primary efficacy endpoint in a Phase III study in patients with wet age-related macular degeneration (AMD).

The endpoint was mean visual acuity gain at nine months. Subjects receiving topically administered squalamine with monthly Lucentis injections (n=119) achieved a mean gain of 8.33 letters from baseline, while those treated with Lucentis monotherapy (n=118) achieved 10.58 letters. There were no differences in the safety profile between the two treatment groups.

Jason Slakter, MD, chief executive officer of Ohr, expressed disappointment and said, “We are grateful to the patients and physicians who participated in the clinical trial. Based on these results, we intend to evaluate strategic alternatives to maximize shareholder value.”

In February 2017, Ohr paused enrollment in the Phase III trial at 200 following the failure of other retinal combo therapies. Ohr said the move would enable it to potentially confirm the visual acuity benefits observed in the patient population it identified as the most likely to benefit from squalamine combination therapy.

Squalamine is intended to inhibit vascular endothelial growth factor, platelet-derived growth factor, and basic fibroblast growth factor. It is based on a compound found in the tissues of the dogfish shark. The FDA granted it fast track designation for wet AMD.

Ohr acquired squalamine from by Genaera Pharma in 2009 as Genaera liquidated its assets.

In April 2017, Ohr closed a $14.2 million public offering.

In December 2016, the company closed a $7.8 million public offering.

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