NPS Pharmaceuticals,
Inc. (Nasdaq: NPSP) announced today that the company plans to advance the
clinical development of its experimental drug teduglutide based upon results
achieved in a Phase 2a proof-of-concept study of 100 patients with moderate to
severe Crohn's disease.
The four-arm, eight-week clinical trial compared three doses of
teduglutide delivered by daily subcutaneous injection to a placebo. The study
was designed to evaluate the drug's safety and potential efficacy in the
treatment of Crohn's disease. Overall, the study results showed a positive
and consistent trend toward efficacy and a dose response favoring the highest
dose group: 36.8% of patients receiving the highest dose of teduglutide
reached clinical remission (Crohn's disease activity index (CDAI) score of
less than 150 points) at week two versus 16.7% of the placebo group, while
55.6% of patients in the highest dose group reached clinical remission by week
eight compared to 33.3% of the placebo group. Teduglutide was well tolerated
with no serious adverse events related to the drug. The most common
treatment-related adverse event in the trial was redness at the injection
site. Study investigators plan to submit the trial results for presentation
at a future medical meeting.
Alan Buchman, M.D., a clinical investigator for the study and associate
professor and director of the IBD Center at Northwestern University's Feinberg
School of Medicine, said, "The results from this preliminary study are
encouraging and warrant further study of this novel agent alone or in
combination with other drugs as a potential new class of therapy for the
treatment of Crohn's disease. Remission rates of this magnitude at two weeks
and eight weeks are unusual in clinical trials and suggest that teduglutide
may play an important role in the management of this difficult-to-treat
disease."
Although the study was not powered to demonstrate statistical significance
and the primary end point (the percentage of patients who achieved remission
or at least a 100-point reduction from their baseline CDAI score at week 8)
was not met due to the relatively small number of study subjects and a high
placebo response, the company believes the high clinical remission rates seen
in patients receiving the highest dose of teduglutide support further
dose-ranging efficacy studies of teduglutide in patients with Crohn's disease.
Hunter Jackson, Ph.D., NPS chairman and CEO, commented, "We are pleased
with the results from this trial and the suggestion that some patients
demonstrated remission as early as two weeks into the study. The high placebo
response seen in this trial is not unusual in Crohn's disease. We plan to
conduct additional studies to confirm the efficacy response observed in this
trial and look forward to advancing this novel compound into later-stage
development this year as a promising treatment alternative in Crohn's
disease."
Teduglutide is a proprietary analog of glucagon-like peptide 2 (GLP-2), a
naturally occurring hormone that regulates the growth, proliferation and
maintenance of cells lining the gastrointestinal tract. A previous Phase 2
clinical study in patients with Short Bowel Syndrome showed that daily
subcutaneous injections of teduglutide resulted in significant growth of the
intestinal lining and improved dietary absorption of nutrients and fluids.
NPS is currently testing teduglutide in a pivotal Phase 3 study as a treatment
for Short Bowel Syndrome.
About Crohn's Disease
Crohn's disease is a chronic inflammatory bowel disease characterized by
inflammation of any part of the gastrointestinal tract and associated with
chronic morbidity. Crohn's disease affects nearly one million patients in the
United States and Europe.
Conference Call and Webcast Information
NPS will conduct a conference call today at 5:00 p.m. EST with Daniel
Present, M.D., clinical professor of medicine at Mt. Sinai School of Medicine,
to discuss the teduglutide study. To participate in the call, dial
800-299-7098 and use passcode 59474346. International callers may dial
617-801-9715 and use the same passcode. In addition, live audio of the call
will be webcast and may be accessed on the Investor Relations page, Calendar
of Events section of the company's website (npsp). The conference
call replay may be accessed by dialing 888-286-8010 (with passcode 42742393).
A replay for international callers can be accessed with the same passcode at
617-801-6888. Both the webcast and conference call will be archived until
March 6, 2006.
About NPS Pharmaceuticals
NPS discovers, develops and commercializes small molecules and recombinant
proteins as drugs, primarily for the treatment of metabolic, bone and mineral,
and central nervous system disorders. The company has one FDA-approved
product, one product candidate undergoing regulatory review for approval to
market in the U.S. and Europe, as well as other drug candidates in various
stages of clinical development backed by a strong discovery research effort.
Additional information is available on the company's website, npsp.
Safe Harbor Statement
Note: Statements made in this press release, which are not historical in
nature, constitute forward-looking statements for purposes of the safe harbor
provided by the Private Securities Litigation Reform Act of 1995. Such
statements include those regarding our expectation that teduglutide may be a
promising treatment alternative in Crohn's disease, our intention to advance
the clinical development of teduglutide into later-stage development this
year, and our intent to commercialize small molecules and recombinant proteins
as drugs. These statements are based on management's current expectations and
beliefs and are subject to a number of factors and uncertainties that could
cause actual results to differ materially from those described in the
forward-looking statements. Such risks and uncertainties include: future
clinicals may demonstrate that teduglutide is not safe and/or efficacious; we
may not be able to enroll patients in our clinical trials in a timely manner;
we may not be able to prepare and finalize clinical protocols in a timely
manner to commence additional clinical trials with teduglutide for Crohn's in
a timely manner; we may not be able to collect, analyze and report data from
our clinical trials in a timely manner; we may never develop additional
products that generate revenues; our product candidates may not prove to be
safe or efficacious; the FDA may delay approval or may not approve any of our
product candidates; current collaborators or partners may not devote adequate
resources to the development and commercialization of our licensed drug
candidates which would prevent or delay introduction of drug candidates to the
market. All information is as of February 27, 2006, and we undertake no duty
to update this information. A more complete description of these risks can be
found in our filings with the Securities and Exchange Commission, including
our Annual Report on Form 10-K/A for the year ended December 31, 2004 and our
Quarterly Report on Form 10-Q for the quarter ended September 31, 2005.
NPS Pharmaceuticals, Inc.
npsp