Cocoa-based drug for persistent cough in final development by SEEK; deal with Pernix

A breakthrough drug containing theobromine, an ingredient naturally present in cocoa and chocolate, is entering the final stages of human clinical trials for the treatment of persistent cough, said researchers at SEEK (formerly known as PepTcell), a UK privately-owned drug-discovery group, and could be on the market within two years.

SEEK also revealed yesterday that it is setting up a new joint venture entity with Pernix Therapeutics. (NYSE Amex: PTX), an integrated specialty pharmaceutical company focused primarily on the US pediatric market. The joint venture will undertake the late-stage development and registration of BC1036, a first-in-class antitussive drug, to address the serious need for an effective, safe, non-opioid treatment for persistent cough. Both parties will also contribute all of their theobromine intellectual property by way of licence or assignment into the joint venture.

Following consultation with a European regulatory authority, the new venture will conduct a single pivotal Phase III trial of BC1036, which is expected to begin in the first half of 2011. This truncated regulatory path is due to the significant historical safety data available for theobromine and the beneficial effect seen in human use to date. The new venture is also in discussions with the US regulatory authorities and expects to be able to confirm the regulatory program in the USA early next year. The new product is intended for non-prescription status.