- Results establish favorable safety profile and show the
potential for efficacy with once-weekly dosing of a next generation
GLP-2 analog
- In head-to-head rat studies, apraglutide
displayed a longer half-life and induced greater intestinotrophic
effects when compared with both teduglutide and glepaglutide at the
same doses
BASEL, Switzerland,
March 25, 2019 /PRNewswire/
-- Therachon AG ("Therachon"), a clinical-stage
biopharmaceutical company focused on the discovery, development and
commercialization of innovative treatments for severe, rare
conditions, today presented results from its Phase 1 trial of
apraglutide in healthy volunteers. The company also presented
results from head-to-head preclinical studies evaluating
apraglutide's PK properties and intestinotrophic effects compared
with other GLP-2 analogs.
Results from both studies were presented at the ASPEN 2019 Nutrition Science & Practice
Conference organized by the American Society for Parenteral and
Enteral Nutrition in Phoenix,
Arizona.
"We are encouraged by the emerging clinical data as they
demonstrate the potential for apraglutide to become a best-in-class
once-weekly treatment for short bowel syndrome," said Luca Santarelli, M.D., chief executive officer
of Therachon. "There is significant potential to improve the care
of SBS patients with a next generation GLP-2 analog that provides a
potentially enhanced PK and efficacy profile, including
improvements in quality of life and treatment adherence."
Phase I trial of apraglutide
The Phase I clinical trial was designed to assess
pharmacokinetics (PK) and pharmacodynamics (PD) of glucagon-like
peptide-2 (GLP-2) analog apraglutide (FE 203799), and to
investigate the safety and tolerability of apraglutide in male and
female healthy volunteers following single and multiple
subcutaneous (SC) or single intravenous (IV) injections.
"The data obtained from this study support a minimum dosing
interval of once-weekly and the favorable safety profile supports
further testing in patients in clinical trials," said Christian Meyer, M.D., Ph.D., chief medical
officer at Therachon.
In the study, apraglutide was generally well-tolerated. There
were no serious adverse events (SAEs) or immunogenicity
observed.
Phase I clinical trial results were presented by Federico Bolognani, M.D., Ph.D., vice president
and Head of Clinical Science at Therachon in a presentation titled:
"Pharmacokinetics and Pharmacodynamics of Glucagon-like Peptide
(GLP-2) Analog Apraglutide (FE 203799) in Adult Healthy Volunteers:
Results of a Phase I Trial."
Head-to-head preclinical studies of apraglutide and other GLP-2
analogs
Head-to-head rat studies were conducted to compare both PK and
intestinotrophic properties of similar doses of apraglutide,
glepaglutide and teduglutide in rats. These studies found that
apraglutide had a longer half-life and induced greater
intestinotrophic effects compared with both teduglutide and
glepaglutide in Sprague-Dawley rats receiving the same dose of
either of the three drugs. Additionally, apraglutide showed an
extended duration of effect, most likely due to its long
half-life.
The comparative study analysis of apraglutide and other GLP-2
analogs was presented by Violetta Dimitriadou, Ph.D., in a
presentation tiled: "Apraglutide Has an Extended Duration and
Induces a Greater Intestinotrophic Effect Compared to other GLP-2
analogs."
About Short Bowel Syndrome
Short Bowel Syndrome (SBS)
results from extensive intestinal resection due to chronic
inflammatory bowel disease (IBD), acute events (e.g. mesenteric
infarction) or congenital abnormalities. Symptoms of SBS include
diarrhea, dehydration, malnutrition and weight loss. To survive,
patients with severe forms of SBS require parenteral support, or
PS, the intravenous delivery of essential nutrients, calories and
fluids. For some patients, PS must be delivered for 10 to 15 hours
per day, a significant burden that severely diminishes quality of
life. An estimated 20,000-40,000 patients are thought to suffer
from SBS in the US and Europe.
About Apraglutide
Apraglutide is designed to increase
the intestine's ability to absorb nutrients and minimize the burden
of parenteral support, thereby improving patients' quality of life
and their ability to thrive. It is a next-generation, synthetic
GLP-2 analog that has undergone extensive preclinical
characterization and optimization. It has successfully completed
Phase 1 single ascending dose/multiple ascending dose clinical
trials in healthy volunteers. Based on preclinical and clinical
data to date, apraglutide has the potential to be a best-in-class
treatment for SBS, designed for dosing no more than once weekly.
Apraglutide is currently being investigated in two Phase 2 clinical
trials in SBS patients in Denmark.
About Therachon
Therachon is a clinical-stage global
biopharmaceutical company focused on the discovery, development and
commercialization of innovative treatments for severe, rare
conditions for which there is significant unmet medical need. The
company is currently advancing a pipeline of therapeutics focused
on rare gastrointestinal and musculoskeletal disorders and
conditions, including both short bowel syndrome and achondroplasia.
Therachon is committed to making a difference in the lives of
patients living with serious rare disorders. For more information,
please visit www.therachon.com.
Visit us on Twitter. Visit us on LinkedIn.
Media Contact
Danielle
Cantey
dcantey@gpg.com
+1 (202) 295-0155
OR
Morgan Warners
mwarners@gpg.com
+1 (202) 337-0808
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