BioWorld International Correspondent

PARIS - GemacBio, a small French company focused on compounds for the treatment of chronic central nervous system disorders and autoimmune diseases, completed a Phase IIa trial of a treatment for multiple sclerosis.

Bordeaux-based GemacBio said its approach to MS as a multifaceted disease led it to design a molecule that targets all aspects of the pathology, using a patented process to graft together several molecules that occur in the human body. The resulting compound has three types of action - anti-inflammatory, immunomodulating and neuroprotecting. In addition, the drug has the advantage of being orally (sublingually) administered and promises a better quality of life for MS sufferers, who normally receive frequent injections.

That said, the drug is not a cure but aimed at arresting the development of the disease before it becomes a handicap, GemacBio CEO Thibault de la Rivière told BioWorld International. He stressed the importance of finding a balance between efficacy and safety, especially for a drug that might have to be taken for 30 years or more.

The compound's therapeutic effect is assured by its triple actions, while its low toxicity means there are no side effects. The Phase IIa trials took place at three sites in France on 22 patients suffering from secondary progressive MS.

GemacBio, which was founded in 2001 and has raised total funding of €4 million (US$4.8 million), mostly from a regional industrial development fund, a local venture capital fund and business angels, now is negotiating a second funding round to enable it to embark on a Phase IIb trial of the product.

De la Rivière said negotiations were well under way with a broader range of potential investors, saying it was time for the company to look deeper for its next funding - both in France and abroad. He said the company needed to raise €8 million to €10 million to fund the next trial and that if the funding round was completed "efficiently," the Phase IIb trial could be initiated before the end of the year. The trial would take place in five European countries.

If that proved the efficacy of the product, de la Rivière said the company would look for a partner to take it into Phase III trials.

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