HEIDELBERG, Germany, June 22, 2011 /PRNewswire/ --
- Primary Endpoint Met
Lipid Therapeutics, a biotechnology company focused on novel
treatments for inflammatory bowel disease, today announced positive
topline results from a Phase IIb clinical trial with its lead
product, LT-02, in patients with ulcerative colitis. LT-02 is a
controlled release formulation of phosphatidylcholine that has been
specifically designed to treat ulcerative colitis by improving the
barrier function of the mucosal layer of the colon, a concept that
has now been successfully tested in several clinical trials.
The Phase IIb trial met the primary end point, change in
SCCAI (Simple Clinical Colitis Activity Index), for patients
refractory to standard first-line intervention who were treated
with LT-02 at 0.8g four times a day (51% reduction with LT-02 vs
33% reduction with placebo; p <0.05). Patients who
received one of two lower doses of LT-02 also showed a positive
benefit. The excellent safety profile of LT-02 treatment was
comparable to placebo at all three doses.
The Phase IIb trial was a randomized, multi-center,
double-blind, parallel group, placebo-controlled, dose ranging
study that was designed to investigate the efficacy and safety of
LT-02 in patients with mesalazine-refractory ulcerative colitis.
156 patients were enrolled into the trial at 24 centers in Germany,
Lithuania and Romania. Patients were randomized to receive one of
three doses of LT-02 or placebo and were treated for a period of 12
weeks. Lipid Therapeutics intends to present full data on the trial
at UEGW in Stockholm in October 2011.
Dr. Gerhard Keilhauer, CEO of Lipid Therapeutics, said:
"The results that we have announced today are a key milestone for
Lipid Therapeutics. We are delighted that LT-02, which has a novel
mode of action, has been shown to be of significant benefit to
patients with ulcerative colitis whose condition has not responded
to the current mainstay of therapy, i.e. mesalazine. We will now
discuss with our European partner, Dr. Falk Pharma, and with
potential partners in the US and Japan how we can rapidly move this
innovative therapeutic into a pivotal Phase III study, the next key
step in making it available to ulcerative colitis patients as
quickly as possible."
Max Karner MD , University Clinic Heidelberg, Germany, who
was the Principal Investigator for the study, said: "The
positive clinical results that we have seen with patients treated
with LT-02 clearly suggests that it has the potential to become a
very attractive new treatment option for patients with ulcerative
colitis who currently have limited options. I would like to take
this opportunity to thank all of the investigators and patients who
took part in this very important study which was completed ahead of
schedule and has delivered excellent results."
About Inflammatory Bowel Disease
Ulcerative colitis is a chronic, relapsing inflammatory disorder
that affects the mucosal lining of the rectum and extends
proximally to affect a variable extent of the colon. Clinical
characteristics include rectal bleeding, diarrhea and abdominal
pain. Worldwide more than 1 million people suffer from ulcerative
colitis. 5-aminosalicylic acid is the standard of care but it often
fails to control the disease in the longer term. Acute flares can
be treated with steroids but they are unsuitable for long-term
treatment, while immunosuppressants have a considerable risk
profile. Despite these treatment options, up to 40% of patients may
require surgical removal of their colon.
LT-02 is a novel controlled release formulation of
phosphatidylcholine that augments the natural protective mucosal
barrier in the lower gut. It is the first product candidate
worldwide that targets the pathological changes in the lower gut
barrier function of colitis patients which are thought to be one of
the main underlying disease causes.
About Lipid Therapeutics
Lipid Therapeutics is a biopharmaceutical company focused on the
development and commercialization of phospholipids and their use
for the treatment of ulcerative colitis. Lipid Therapeutics was
founded in 2008, based on groundbreaking scientific work performed
by Prof. Wolfgang Stremmel at the Krehl University Clinic in
Heidelberg. The company is headquartered in Heidelberg (Germany)
and is financed through the EMBL Technology Fund and CD Ventures.
In August 2009, Lipid Therapeutics concluded a co-development and
option agreement for its lead product LT-02 with market leader Dr.
Falk Pharma, Freiburg (Germany).
Contact Lipid Therapeutics GmbH:
Dr. Gerhard Keilhauer
Citigate Dewe Rogerson:
Sita Shah / Chris Gardner
SOURCE Lipid Therapeutics