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Protein Design heart drug works well in trial

Posted on: Sunday, 4 September 2005, 04:26 CDT

By Ben Hirschler

STOCKHOLM (Reuters) - An experimental drug from U.S. biotechnology firm Protein Design Labs Inc. can relieve symptoms and cut mortality in patients with advanced heart failure, researchers said on Sunday.

Results of a Phase II clinical trial found that ularitide -- a key new product for the company -- helped patients with acute decompensated congestive heart failure (ADHF), without causing kidney toxicity.

Maintaining kidney function is particularly important in patients with decompensated congestive heart failure, which occurs when the heart is unable to maintain adequate circulation of blood in the body's tissues.

Trial investigator Dr. Veselin Mitrovic of the Kerckhoff Clinic, Bad Nauheim, Germany, said ularitide was an exciting potential new treatment for heart failure.

"Ularitide holds significant potential to address unmet needs in management of ADHF," he said.

"We didn't see any erosion of renal (kidney) function, which is very important because heart failure is a cardio-renal syndrome."

Results of the study, involving 221 patients, showed those on the drug had reduced pressure in the pulmonary veins and improved shortness of breath scores, compared to patients given a placebo.

The researchers also found there was a reduction in hospital stays among patients taking the medicine and a fall in mortality 30 days after treatment, although these factors were not the primary endpoints of the study.

The death rate among those patients given a placebo was 13.2 percent while mortality among those on ularitide was between 1.8 and 3.8 percent, depending on which of three doses of the drug was given.

FURTHER STUDIES PLANNED

The results of the study were presented at the European Society of Cardiology congress in Stockholm. Protein Design had already told investors in April that the study had produced positive results, but without giving details.

Dr. Steve Benner, the company's medical director, said further studies were now planned and researchers aimed to assess the benefits of ularitide in patients with earlier disease.

"We anticipate that the next studies will explore a slightly different patient group, and we would expect a new Phase II trial will probably get under way in the U.S. and Europe at the very end of this year or the start of next year," he told Reuters.

No decision has yet been taken on when to initiate pivotal Phase III trials, which Benner said would likely involve between 2,000 and 3,000 patients.

Industry analysts believe that ularitide, if successful, could have blockbuster sales potential.

It will compete with Johnson & Johnson's similar product Natrecor, which is already on the market in the United States, though not in Europe.

Natrecor has been a commercial success but it ran into controversy earlier this year after a medical journal linked it to worsened kidney function.

Ularitide is a synthetic form of a naturally occurring human protein produced in the kidney, where it regulates levels of fluid and sodium.

Source: REUTERS

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