Description:
Inflammatory
Bowel Disease (IBD) which represents a spectrum of diseases of the lower GI
tract, notably Ulcerative Colitis (UC) and Crohn’s Disease (CD), is one of the
most common gastrointestinal (GI) afflictions in the United States and Europe.
It is also noteworthy that the incidence of UC has increased 2-3 fold in China
and other counties in Asia adopting a more Westernized diet/lifestyle over the
past decade. It has been estimated by the CDC that health care cost of $1.7
billion in the US are directly attributable to patients afflicted with UC and
CD. When one includes lost wages, estimates as high as $6 billion/yr have been
estimated in the US alone due to patients being inflicted with either UC or CD.
Typically IBD is diagnosed by age
30 and requires treatment for the rest of the person’s life. These IBD diseases, which affect the
colon and distal small bowel are manifested by episodes of GI bleeding,
diarrhea, fever, infection and in the most advanced cases, lower gut
fistulation, perforation and
colorectal cancer . One therapy, 5-amino salicylic acid (5-ASA), also called
mesalamine, has been used medically to manage patients with IBD and notably UC
patients, though its effectiveness to keep patients in remission over the
long-term has been limited. Although 5-ASA is an effective treatment, there is a
need in the art for 5-ASA preparations having improved efficacy to treat IBD
increased potency (to lower pill burden) and to keep patients in remission. It
also should be noted that the market for 5-ASA containing pharmaceuticals has
not been diminished by the advent of biologics (e.g anti-TNF antibody), that have their
own limitations (potential for serious adverse events, high cost and development
of resistance) and are frequently used in combination with
mesalamine.
The
Technology
Scientists at
the University of Texas Health Science Center at Houston have developed novel
formulations of 5-ASA for the treatment of IBD. The novel formulations combine 5-ASA or
5-ASA containing pharmaceuticals (such as Mesalamine, Sulfsalazine, Olsalazine,
or Balsalazide) with a phospholipid or phospholipid-containing oil, either
covalently or non-covalently. The
unique composition has shown efficacy in attenuating mucosal injury/bleeding in
rodent models of IBD, but also has shown enhancement of the activity of the
5-ASA. This enhancement is likely a result of the phospholipids additionally
acting to help fortify the hydrophobic barrier properties of the affected
mucosa, which are attenuated in IBD.
Possible Features and
Benefits
·
improved efficacy of
5-ASA
·
potential to reduce pill burden due
increased potency
·
fortification/restoration of the GI
mucosa
UTHealth
Ref. No.: 2006-0040
Inventors: Dr. Lenard M.
Lichtenberger
Patent
Status: Issued US Patent Nos. 7,700,651 & 8,252,836; issued
patents in China, Canada and Australia; pending
patents in a number of other
international jurisdictions.
License
Available: world-wide, exclusive or
non-exclusive