MADISON, Wis., Oct. 15, 2014 —
Deltanoid Pharmaceuticals announces the successful completion of a phase 2B
clinical trial for its lead experimental drug DP001 for the treatment of
secondary hyperparathyroidism in patients with chronic kidney disease receiving
hemodialysis.
“We believe DP001 is the most potent active vitamin
D available,” says Hector DeLuca, CEO of Deltanoid and a pioneer in the
field. “It is safer, works longer and may eliminate the need for costly
calcimimetic therapy.”
The results of the trial will be presented at the
American Society of Nephrology meeting this November in Philadelphia. Deltanoid
has an exclusive license to DP001 from the Wisconsin Alumni Research
Foundation.
In a 12-week double-blind, randomized, placebo-controlled
study, 62 patients received DP001 or placebo three times per week at the
completion of a dialysis session. Results show that an overall 46 percent
reduction in parathyroid hormone (PTH) from baseline was achieved in
DP001-treated subjects, whereas there was an increase in PTH of 31 percent in
the placebo group.
Patients who had been managed on other commercially
available active vitamin D (AVD) combined with calcimimetic therapy prior to
entering the clinical trial were equally well managed on DP001 as the sole
therapy. Thus, DP001 effectively eliminated the need for adjunctive
calcimimetic therapy in the majority of hemodialysis patients previously
requiring both treatments.
“One of the unique properties of this new drug is
its selectivity for the parathyroid gland,” says DeLuca. “That means
less adverse side effects in other tissues.”
DP001 was safe at all doses administered in the study,
and no DP001-treated patients exceeded the safety threshold for
albumin-corrected serum calcium. More adverse events were reported in the
placebo than the DP001 group, and none of the serious adverse events reported
during the trial were deemed DP001-treatment related.
Moreover, previous testing in an animal model of renal
failure showed that DP001 has a wider therapeutic window and continued to
suppress PTH as the disease progressed, while a leading commercially available
AVD did not.
Deltanoid is expecting to file a new drug application in
the next two years.
About Deltanoid
Deltanoid is a small biopharmaceutical company based in
Madison, Wisconsin, devoted to the development of early university-based
inventions into commercial products with special emphasis on vitamin D-based
pharmaceuticals. For more information, visit deltanoid.com.
Dr. Hector F. DeLuca, CEO of Deltanoid, has been
responsible for most of the currently used active vitamin D compounds in this
and other applications, including Rocaltrol(R), Calcijex(R), Hectorol(R),
Zemplar(R), One-Alfa(R) and Alfarol(R).
About WARF
The Wisconsin Alumni Research Foundation (WARF) helps
steward the cycle of research, discovery, commercialization and investment for
the University of Wisconsin-Madison. Founded in 1925 by Professor Harry
Steenbock (Hector DeLuca’s mentor) as an independent, nonprofit foundation,
WARF manages more than 1,600 active patents and an endowment of $2.6 billion as
it funds university research, obtains patents for campus discoveries and
licenses inventions to industry. For more information, visit warf.org.
About secondary hyperparathyroidism (SHPT)
SHPT is a common and serious condition that affects many
of the millions of dialysis patients throughout the world. The disorder
develops in response to chronic kidney failure. With a loss of kidney function,
there is a failure to convert vitamin D to its active form,
1alpha,25-dihydroxyvitamin D3. As a result, calcium is not absorbed or
mobilized, resulting in chronically low serum calcium. The parathyroids (four
small glands in the neck) are the sensors of serum calcium and secrete
parathyroid hormone to mobilize calcium in response to the low levels. This can
result in SHPT leading to bone deterioration. Active 1alpha-hydroxylated
vitamin D compounds act directly on the parathyroids to suppress parathyroid
hormone synthesis and secretion.
Nephrologists treat SHPT by administering active
1alpha-hydroxylated vitamin D compounds. In difficult to manage patients, a
calcimimetic that reduces the impact of low blood calcium on parathyroid
secretion is also administered. The currently used therapies in the U.S. are
calcitriol, Hectorol(R), Zemplar(R) and Sensipar(R). In addition, maxacalcitol
and Alfarol(R) also are in use in Japan.
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