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Squalamine for AMD begins phase 2 trial

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PLYMOUTH MEETING, Pa. — A third U.S. phase 2 trial of an anti-angiogenic drug for the treatment of wet age-related macular degeneration began late last month, the drug’s developer said in a press release. The company, Genaera, also announced that the Food and Drug Administration has granted fast-track status for the drug to expedite the approval process.

Genaera’s squalamine is a “first-in-class small molecule anti-angiogenic drug candidate,” according to a press release from the company. The new phase 2 study will evaluate three doses of squalamine — 10, 20 and 40 mg — in combination with an initial Visudyne (verteporfin for injection, Novartis/QLT) treatment in 45 patients with wet AMD.

“Based on its mechanism of action, squalamine has the potential to inhibit detrimental effects of the VEGF ‘burst’ that commonly occurs after Visudyne treatment,” according to the press release. The trial involves monthly squalamine maintenance therapy and 12-month follow-up in each patient, the company noted.

The fast-track designation from the FDA, announced in a separate press release from Genaera, is meant to facilitate the development of drugs that address unmet medical needs, the company said.

In yet another press release, the company announced that the National Eye Institute has awarded Genaera $100,000 to further develop squalamine-related aminosterols as next-generation anti-angiogenic medications for the treatment of wet AMD.