Emtora Clinical Data to be Highlighted in Podium Presentation at Prestigious 2024 Digestive Disease Week Annual Meeting
April 30 2024 - 9:02AM
Business Wire
Results of Multicenter Phase 2 Trial in
Familial Adenomatous Polyposis to be Presented
Grant-Funded Registrational Trial Set to
Commence Early Next Year
Emtora Biosciences, Inc., a privately-held, San Antonio-based
biotechnology company developing a novel reformulated version of a
previously-approved drug today announced the acceptance of an
abstract for oral presentation at the upcoming Digestive Disease
Week (“DDW”) Annual Meeting. DDW is the world’s premier meeting for
physicians, researchers, and industry in the fields of
gastroenterology, hepatology, endoscopy, and gastrointestinal
surgery, which will take place in Washington D.C. May 18-21,
2024.
Dr. Carol Burke, MD, Principal Investigator, will present the 6
month primary endpoint data of a multi-center Phase 2 trial of
Emtora’s eRapaTM in patients with Familial Adenomatous Polyposis
(or “FAP”), a genetic disease characterized by the proliferation of
precancerous polyps in the gastrointestinal tract, see
https://clinicaltrials.gov/ct2/show/NCT04230499.
FAP is an incurable systemic disease for which no approved
chemo-preventive agent exists. mTOR, a ubiquitous biological
pathway, is over-expressed in FAP polyps. eRapaTM is a safe,
predictable and potent mTOR inhibitor with a unique formulation
designed for chronic use.
“eRapaTM has the potential to reduce the progression of FAP
polyps and thereby may delay, or even eliminate in some cases, the
need for surgical intervention, which is associated with a
devastating impact on quality of life in FAP patients. We look
forward to sharing the 6 month safety and efficacy data in our
Phase 2 trial of eRapaTM in FAP at DDW and to the initiation of a
registrational trial in FAP in the first quarter of next year,”
said Dr. George Peoples, MD, Chief Medical Officer of Emtora
Biosciences.
Emtora’s Phase 2 trial of eRapaTM in FAP was funded by an
earlier product development grant (DP190069) from the Cancer
Prevention and Research Institute of Texas (“CPRIT”) totaling
$3,000,000. The Company previously announced its receipt of a new
product development award (DP220053) from CPRIT that will provide
nearly $17,000,000 in non-dilutive funding to complete further
clinical and product development of eRapaTM, including the
execution of a multicenter, randomized, placebo-controlled, Phase 3
registrational trial of eRapaTM in the lead indication of FAP. Dr.
Carol Burke will serve as the Global Principal Investigator for the
trial, which is set to commence later this year. Additional details
regarding the DDW presentation are provided below.
Presentation: PHASE IIA TRIAL OF ENCAPSULATED RAPAMYCIN
(ERAPA) IN PATIENTS WITH FAMILIAL ADENOMATOUS POLYPOSIS TO REDUCE
INTESTINAL POLYP BURDEN: 6 MONTH INTERIM RESULTS Session:
Chemoprevention for GI Cancers: Drugs and/or Bugs Session
Type: Research Forum Abstract Number: 4041480 Embargo
Date: 21-May-2024 Embargo Time: 12:01 a.m. EST
Presentation Date: 21-May-2024 Start Time: 2:00 PM
EST End Time: 2:15 PM EST Location: 146AB
Presenter: Carol Burke, MD, Director of Hereditary Polyposis
in the Sanford R. Weiss MD Center for Colorectal Neoplasia in the
Digestive Disease Institute at Cleveland Clinic
About DDW
Digestive Disease Week® (DDW) is the largest international
gathering of physicians, researchers and academics in the fields of
gastroenterology, hepatology, endoscopy and gastrointestinal
surgery. Jointly sponsored by the American Association for the
Study of Liver Diseases (AASLD), the American Gastroenterological
Association (AGA), the American Society for Gastrointestinal
Endoscopy (ASGE) and the Society for Surgery of the Alimentary
Tract (SSAT), DDW is an in-person and online meeting from May
18-21, 2024. The meeting showcases more than 4,400 abstracts and
hundreds of lectures on the latest advances in GI research,
medicine and technology. More information can be found at
www.ddw.org.
About Emtora Biosciences
Emtora Biosciences is a clinical stage biopharmaceutical company
headquartered in San Antonio, Texas. The company is developing
eRapaTM, an encapsulated formulation of the previously approved
rapamycin, for the treatment of rare genetic diseases and cancer.
Emtora’s lead indication is Familial Adenomatous Polyposis. The
ubiquitous mTOR protein, involved in multiple signaling pathways,
is overexpressed in FAP polyps. eRapaTM is a potent mTOR inhibitor
believed to provide several significant advantages over rapamycin
including: targeted delivery to the site of active disease (in
addition to systemic exposure); reduced toxicity and improved
tolerability; consistent pharmacokinetics (potentially eliminating
the need for drug level monitoring) and improved bioavailability.
eRapaTM was originally developed at University of Texas Health San
Antonio and is currently the subject of two ongoing and
grant-funded Phase 2 trials. For more information, please visit
www.emtorabio.com.
About the Cancer Prevention and Research Institute of
Texas
CPRIT was created by the Texas Legislature and approved by a
statewide vote in 2007 to lead the Lone Star State’s fight against
cancer. In 2019, Texas voters again voted overwhelmingly to
continue CPRIT with an additional $3 billion for a total $6 billion
investment in cancer research and prevention. To date, the agency
has awarded more than $3 billion in grants to Texas research
institutions and organizations through its academic research,
prevention, and product development research programs. CPRIT has
also recruited 306 distinguished researchers to Texas, supported
the establishment, expansion, or relocation of 62 companies to
Texas, and supported 9.4 million prevention services reaching all
254 counties in Texas. Learn more at https://cprit.texas.gov.
Forward-Looking Statements
We make no assurances as to any forward-looking statements in
this press release. Actual results could differ materially. We will
not update or supplement any forward-looking statements. You should
not rely on any forward-looking statements.
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Emtora Biosciences Shannon Kingman MBA VP, Corporate Operations
shannon@emtorabio.com