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Paloma Pharmaceuticals initiates phase 1 study of anti-angiogenic agent for neovascular AMD
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JAMAICA PLAIN, Mass. — Paloma Pharmaceuticals has received investigational new drug clearance by the U.S. Food and Drug Administration to launch a phase 1 clinical program evaluating the safety, tolerability and pharmacokinetic profile of a novel anti-angiogenic agent for treating patients with age-related macular degeneration, the company announced
The nonsteroidal, synthetic small molecule, known as Palomid 529 (P529), targets and inhibits the PI3K/Akt/mTOR signal transduction pathway and is the first-in-class PI3K/Akt/mTOR inhibitor that has the ability to dissociate both the TORC1 and TORC2 complexes, according to a press release from the company.
The open-label, dose-ranging study will assess the safety and efficacy of single intravitreal and subconjunctival doses of P529 among patients with advanced neovascular AMD.
"We are pleased to have the FDA accept our IND package for initiation of phase 1 human studies. This external validation of P529 as a therapeutic agent to combat eye disease gives credence to not just our program for ocular disease but as P529 will be used formulated for other therapeutic areas, it also leads the way for acceptance of upcoming phase 1 studies in cancer, epilepsy, dermatologic diseases and other indication areas in our pipeline," David Sherris, PhD, president and CEO of Paloma Pharmaceuticals, said in the release.
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