Monday, November 21, 2011

Chapel Hill Drug Start-up Raises $1.25 Million

Topical non-steroidal anti-inflammatory drugs have have been limited by the difficulty of getting an active ingredient to effectively penetrate the skin.

Chapel Hill-based pharmaceutical company Exodos Life Sciences aims to break that barrier with its drug candidate, ELS115.

The company is raising money to help the effort. Exodos raised $1 million from an offering of equity and options that drew interest from 15 investors, according to a November 3 securities filing. Now the company is raising money again. Another securities filing last week showed that Exodos raised $250,000 of a new $500,000 goal.

The cash infusion comes as Exodos makes progress toward clinical trials of ELS115. The company has met with the U.S. Food and Drug Administration to discuss the drug candidate and now expects to be ready to file an investigational new drug application by the middle of next year.

ELS115 is being developed with technology licensed from San Diego, California biotechnology company Apricus Biosciences (NASDAQ: APRI). Apricus’ technology platform NexACT improves the delivery of the active drug with the addition of non-active ingredients, or excipients. The biodegradable excipients help a drug penetrate the skin.

Exodos’ ELS115 combines the already approved pain drug ketoprofen with Apricus’ patented drug delivery technology. The objective is developing an effective treatment that offers pain relief in a more localized manner compared to a pill. This delivery option could be preferable for patients who have gastrointestinal problems or may otherwise experience side effects from a pain drug in pill form.

Exodos launched in 2009. The privately-held company focuses on developing drugs that go through the FDA’s 505(b)(2) process, which is used for previously approved drugs that have a limited change. Companies pursuing a 505(b)(2) filing must demonstrate that the drug remains still safe and effective with the change; it’s a faster regulatory pathway than a new drug application. Apricus said that Exodos could be the first of its licensing partners to start human studies with the NexACT technology.