BioWorld International Correspondent

Ipsat Therapies Oy raised €7 million (US$9 million) in a funding round that will enable it to move its lead development candidate, the antibiotic therapy P1A, into a Phase IIb trial.

The Helsinki, Finland-based company also appointed several new members to its board, including Wolfgang Pieken, CEO of Ebersberg, Germany-based MWG Biotech AG, who has assumed the role of executive chairman.

The money will fund the company to the latter part of 2006, said CEO Marion Carson, by which time the company's proof-of-concept trial should be completed. It is due to get under way in the fourth quarter - the company is still finalizing its plans - and will take between eight and 12 months to complete.

Bio Fund Management Oy, also of Helsinki, led the latest financing round, which takes Ipsat's total funding to €19 million since its formation in 1999. Other investors included Suomen Teollisuussijoitus Oy (Finnish Industry Investment), the Varma Mutual Pension Insurance Company and Sitra (the Finnish National Fund for Research and Development), all of Helsinki.

The company was founded to commercialize a method for improving beta lactam antibiotic therapy, particularly in patients with risk factors for developing complications during treatment. It comprises an orally administered pellet, containing recombinant beta lactamase enzyme, which is given in conjunction with an antibiotic.

Typically, part of an oral antibiotic dose is not absorbed via the intestinal wall, but passes into the colon, at which point it can disrupt the normal flora. Intravenously administered antibiotics also can end up at the same site, via enterohepatic circulation, biliary excretion or diffusion, the company said.

In each case, the resident microflora can be disrupted, leading to diarrhea, bacterial resistance, overgrowth of pathogenic organisms, intestinal infection or colitis. The beta lactam enzyme is intended to mop up the excess antibiotic in order to safeguard the resident flora from such disruption and prevent those complications.

"We are the only company that can operate in this area at the moment," Carson said. The approach is a Finnish invention and is protected by patent, she added.

The company has published pharmacokinetic data indicating that the plasma concentration of antibiotic is not affected by the concomitant administration of enzyme, while the residual antibiotic in the colon is fully eliminated. The company also presented data from a Phase IIa trial at the 15th European Congress of Clinical Microbiology and Infectious Diseases in Copenhagen, Denmark, last week, which, the company said, indicates that P1A prevented the emergence of bacterial resistance and the depletion of intestinal flora over a five-day treatment period. The randomized, open-label study involved 36 healthy volunteers who received either ampicillin alone, ampicillin plus Ipsat P1A, or Ipsat P1A alone.

The company has resources to fund the upcoming trial, but it also is open to partnering out the project if the right terms are offered, Carson said.