– 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 — 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 anExtended 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.
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.
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.
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