Protein Design heart drug works well in trial
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.