Renexxion Ireland Ltd. and Dr. Falk Pharma GmbH Announce Expansion of the Phase 2b MOVE-IT Study of Naronapride in Gastroparesis and Dosing of the First United States Patient
13 Agosto 2024 - 7:30AM
Renexxion Ireland Limited (“Renexxion”), a private
biopharmaceutical company committed to delivering innovative drugs
to patients with high unmet need in gastrointestinal (“GI”)
disorders, in collaboration with its partner Dr. Falk Pharma GmbH
(“Dr. Falk Pharma”), announce dosing of the first patient in the
United States (U.S.) in the ongoing global Phase 2b MOVE-IT study
(ClinicalTrials.gov ID: NCT05621811) evaluating the safety and
efficacy of naronapride for the treatment of gastroparesis. The
MOVE-IT study started dosing patients in Europe in February 2023
and has now expanded to include U.S. patients after recent IND
clearance from the FDA for investigating naronapride in
gastroparesis patients.
“As a part of our goal to harmonize clinical development and
regulatory pathways in the U.S. and EU, we are delighted to
announce the dosing of the first U.S. patient in our collaborative
Phase 2b study with Dr. Falk Pharma, marking a key milestone in the
development of naronapride for gastroparesis. This latest
achievement is a testament to the strength of our joint-clinical
development team, and our unwavering commitment to provide a safe
and effective treatment for gastroparesis.” said Dr. Peter Milner
M.D., FACC, Chairman, and CEO of Renexxion. “The rapid integration
of multiple research sites across the U.S. signifies the widespread
recognition of the potential benefits that naronapride may offer to
patients with gastroparesis.”
Dr. Kai Pinkernell, M.D., Managing Director, Science &
Innovation at Dr. Falk Pharma, added, "As the partner in Europe and
Australasia, we are pleased to announce that Renexxion has
facilitated the expansion of our ongoing Phase 2b MOVE-IT study to
clinical sites in the U.S. The extension of this study is a
testament to our strong partnership and will expedite the clinical
development of naronapride for gastroparesis in our respective
territories, as well as for other indications related to impaired
GI motility."
Naronapride is a potential best-in-class oral, locally acting
pan-GI prokinetic that works by modulating two validated targets on
the luminal surface of the intestinal wall, 5-HT4 receptor agonism
and D2 receptor antagonism, with a well-differentiated
pharmaceutical, pharmacokinetics, safety, and efficacy profile from
other 5-HT4 agonists.
Gastroparesis is characterized by delayed gastric emptying in
the absence of mechanical obstruction and is caused primarily by
diabetic and idiopathic etiologies, with some recent increases in
iatrogenic disease potentially associated with widespread use of
anti-obesity medications such as glucagon-like peptide-1 (GLP-1)
agonists. Gastroparesis is a prevalent condition globally, with
approximately 1.7% of the population in the U.S. and 1% in Europe
having gastroparesis-like symptoms. Gastroparesis affects
9.3% of patients with diabetes, while 15-30% of patients taking
GLP-1 agonists experience nausea and 5-10% experience vomiting,
both of which are common symptoms of gastroparesis.
There is a large, unaddressed demand for a safe and efficacious
long-term therapy for gastroparesis. GI prokinetics play a crucial
role in managing this condition. However, the most prescribed
options have limited efficacy and cause off-target side effects,
including permanent damage to the central nervous system and
life-threatening cardiac arrhythmias. Naronapride is a potential
best-in-class solution for this large and underserved patient
population due to its clinically validated dual-action therapeutic
approach and its favorable safety profile to date, which has been
demonstrated across four Phase 2 trials and eight Phase 1 trials.
Moreover, naronapride has already shown dose-dependent acceleration
of gastric emptying in a GI transit study involving healthy human
volunteers.
“The rising prevalence of gastroparesis means increasingly more
patients are experiencing symptoms of abdominal discomfort, nausea
and vomiting, without having access to a safe and efficacious
long-term treatment,” said Jan Tack, MD, PhD, Professor and Head of
Clinic in the Department of Gastroenterology at University
Hospitals Leuven, Leuven, Belgium, and Principal Investigator for
the MOVE-IT study. “A recently published meta-analysis demonstrated
that pure 5-HT4 agonists are associated with significant
improvement in gastroparesis cardinal symptom index (GCSI) scores
and faster gastric emptying time. This evidence supports the
development of a novel 5-HT4 receptor agonist with the added
synergistic benefit of D2 receptor antagonism, as a viable
treatment for gastroparesis”, he added.
About Naronapride Renexxion
Ireland’s lead program is naronapride, a late-stage potential
best-in-class drug candidate for unmet GI indications in the upper
and lower GI tract. In scientific studies, naronapride has been
demonstrated to possess a unique combination of both serotonin
5-HT4 receptor agonistic and dopamine D2 receptor antagonistic
properties, both clinically validated targets. Naronapride was
designed to be minimally absorbable and locally active in the gut
lumen following oral administration to potentially enhance efficacy
and safety. Four positive Phase 2 studies of naronapride have been
completed. A Phase 2b study of naronapride in PPI-non-responsive
symptomatic GERD is expected to commence in the next 12 months
following the recent receipt of a May Proceed Letter and IND
clearance from the FDA. Naronapride is also Phase 3 ready in
chronic idiopathic constipation (“CIC”).
About MOVE-IT MOVE-IT is a Phase 2b,
double-blind, randomized, multicenter, placebo-controlled study
designed to evaluate the efficacy, safety, and tolerability of
naronapride in treating patients with idiopathic or diabetic
gastroparesis. This trial compares the effects of three daily doses
of naronapride (10 mg, 20 mg, and 40 mg TID) versus placebo over 12
weeks in approximately 320 patients, aiming to alleviate
gastroparesis symptoms and improve quality of life.
About Renexxion Ireland Renexxion
Ireland Limited, a wholly owned Irish subsidiary of
California-based Renexxion, Inc, is a privately held
biopharmaceutical company committed to developing new drugs for
patients with GI disorders. In addition to developing its lead
product candidate, naronapride, Renexxion Ireland is currently
advancing an additional research program focused on developing
innovative drug candidates for inflammatory bowel disease
(“IBD”) through the utilization of novel protein-drug
conjugates.
Further information on Renexxion Ireland can be found online:
http://www.rnexltd.ie.
About Dr. Falk Pharma GmbH Dr. Falk Pharma
GmbH has been developing and marketing innovative medicines to
treat a wide range of gastrointestinal disorders like inflammatory
bowel disease or eosinophilic esophagitis as well as hepato-biliary
disorders such as primary biliary cholangitis for over 60 years. As
the international experts in digestive and metabolic medicine, the
company brings together physicians, scientists, and patients to
devise new and powerful approaches to patient care. Dr. Falk Pharma
engages in pre-clinical and clinical stage research that aims to
meaningfully improve therapeutic practice as well as patient health
and well-being. A family-owned business with a global presence, Dr.
Falk Pharma has ten affiliates in Europe and Australia and is
continuously growing. The company has its headquarters and R&D
facilities in Freiburg, Germany, its pharmaceutical products are
manufactured in Europe, mainly at sites in Germany, France, Italy,
and Switzerland. The Falk Group has a global workforce of around
1,250 employees, with 294 of the employees based in
Freiburg. Further information on Dr. Falk Pharma
can be found online: https://drfalkpharma.com.
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Inquiries: Press@rnexltd.ie +353 61
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