Achelios Therapeutics, a startup drug-development company based in Chapel Hill, is reporting promising test results for its experimental topical treatment for migraine headaches.
Achelios announced Tuesday that a Phase 2a study of Topofen, a gel that permeates the skin and is applied over cranial nerves between the ear and the jaw, found that 45 percent of acute migraine sufferers enjoyed pain relief for 2 to 24 hours. That compares to 15 percent of patients treated by a placebo.
In addition, 50 percent of the patients who treated severe pain with Topofen were pain-free 24 hours later, versus 25 percent of placebo-treated patients.
The study involved 48 patients.
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The crucial advantage of Topofen is that it avoids the side effects that plague oral migraine medications – gastric bleeding and ulcers, said Crist Frangakis, president and CEO.
Indeed, the active ingredient in Topofen is ketoprofen, a generic nonsteroidal anti-inflammatory drug that is available orally but is little-prescribed in the U.S. because of its side effects.
“The innovation we did was create a gel that allows the drug to permeate the skin with very high efficiency,” Frangakis said. The amount of ketoprofen in Toprofen is about one-tenth the amount used orally, he added.
Achelios, which was founded in 2012, has raised nearly $10 million from angel investors and has six full-time employees – three in Chapel Hill and three at its research lab in San Diego.
The company’s next step is conducting a larger Phase 2b study involving 100 to 200 patients that would be used to determine the optimum dosage.
But in order to do that, it needs to either raise additional funding – about $25 million is needed to take the drug all the way to the point that it could apply for regulatory approval – or team up with a large pharmaceutical company. Achelios is pursuing both options.
“It’s not good to rely on just one route,” Frangakis said.