A new migraine treatment from pharmaceutical startup Achelios Therapeutics could enter clinical trials later this year, and it will be a new take on an older pain drug.
The Chapel Hill, North Carolina company has raised $1.8 million out of a targeted $3 million first round of financing as the company launches operations and pursues a treatment to address migraine headaches and peripheral pain. The company formed at the end of January, according to corporation records filed with the North Carolina Secretary of State. CEO Crist Frangakis said he did not want to say too much about the company or its drug program because it is still in the midst of raising money. But he did say that the company aims to bring its migraine and peripheral pain compound into clinical trials, perhaps this year.
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“We’re still in the preclinical stage,” Frangakis said. “We hope to be in the clinic soon.”
The name Achelios plays on the name “Achelois.” The Greek goddess’ name loosely translates as “she who washes away pain.” The company Achelios did not discover a new compound, nor did it license a migraine headache treatment from another entity. Achelios is working on a reformulation of an existing treatment. That’s the same model pursued by Exodos Life Sciences, the Chapel Hill company that spun off Achelios. In addition to sharing executives — Frangakis is also CEO of Exodos — the two companies share the same Chapel Hill business address.
Exodos doesn’t do any drug discovery work. The company instead reformulates existing products that have already been approved by the U.S. Food and Drug Administration as safe and effective. The reformulation could be in a form that is easier to administer. That is what Exodos is doing with drug candidate ELS115, a compound the company is developing as an anti-inflammatory drug delivered as a topical treatment that can penetrate the skin. Exodos said last fall it expects to file an investigational new drug application on that compound by mid 2012.
Exodos’ work with reformulations uses the FDA’s 505(b)(2) process, which applies to previously approved drugs that have a limited change. These filings rely on the safety and efficacy data of the already-approved drug. The company needs to show in clinical trials only that the drug is still safe and effective with the change. It’s a faster pathway than filing a new drug application.
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Exodos’ ELS115 is being developed with technology licensed from San Diego, California biotechnology company Apricus Biosciences. Apricus’ patented drug delivery technology improves delivery of a drug’s active ingredient by adding nonactive ingredients that help a drug penetrate the skin. A topical option offers an alternative for patients who experience gastrointestinal problems or other side effects from pain drugs administered in pill form.
Pills used to treat migraine headaches do come with side effects. Ibuprofen and acetaminophen can irritate the stomach and lead to ulcers or gastrointestinal bleeding. Triptans are a commonly prescribed migraine treatment. But this class of drugs comes with cardiovascular risks. As a reformulation, Achelios’ migraine treatment will have a faster regulatory path than a completely new drug candidate. If Achelios is using for that treatment the same topical drug delivery technology licensed from Apricus, the company could have on its hands a novel migraine treatment that doesn’t pose the stomach or cardiovascular risks as the current slate of migraine treatments — an advantage that would come from delivery through the skin.
[Photo from stock.xchng user Marcelo Gerpe]