Lipid Therapeutics Announces Positive Topline Phase IIb Results With LT-02 in Patients With Ulcerative Colitis
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 Managing Director Phone: +49-6221-3350581 Fax: +49-6221-3350589 Email: email@example.com [firstname.lastname@example.org ] http://www.lipid-therapeutics.com Citigate Dewe Rogerson: Sita Shah / Chris Gardner Phone: +44(0)-20-7282-1052 Email: email@example.comfirstname.lastname@example.org
SOURCE Lipid Therapeutics