RELEASE: Renexxion Ireland Ltd. and Dr. Falk Pharma GmbH announce the initiation of a Phase II study of naronapride (1)

(Information sent by the signatory company).

RELEASE: Renexxion Ireland Ltd. and Dr. Falk Pharma GmbH announce the initiation of a Phase II study of naronapride (1)

(Information sent by the signatory company)

-Renexxion Ireland Ltd. and Dr. Falk Pharma GmbH announce the initiation of a Phase II study of naronapride in patients with gastroparesis

Randomized, double-blind, placebo-controlled study to evaluate the efficacy of a new pan-GI prokinetic in patients with gastroparesis

ROSCREA, Ireland and FREIBURG, Germany, Feb. 15, 2023 /PRNewswire/ -- Renexxion Ireland Limited, a private biopharmaceutical company committed to providing innovative medicines to patients with high unmet need for gastrointestinal ("GI") disorders, will is pleased to announce that the first patient in Europe has been treated with naronapride, a potentially best-in-class pan-GI prokinetic, in a Phase IIb trial for gastroparesis led by Dr. Falk Pharma GmbH (Dr. Falk Pharma).

The Phase IIb trial is a multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of naronapride in patients with gastroparesis. Study investigators will randomly enroll approximately 300 patients to receive naronapride at one of three doses or placebo daily for 12 weeks. The primary endpoint of the trial is the change in signs and symptoms of idiopathic or diabetic gastroparesis from baseline. Several additional secondary and exploratory endpoints will also be evaluated to elucidate the efficacy and safety profile of naronapride, compared to placebo.

Gastroparesis is a severe chronic disorder characterized by delayed gastric emptying that causes upper gastrointestinal symptoms such as nausea, vomiting, or bloating. Gastroparesis is frequently associated with significant impairment in social and occupational functioning. Despite the great unmet medical need, there is no drug approved for this indication.

"At Renexxion Ireland, we are delighted to be working with Dr. Falk Pharma to bring naronapride to market in greater Europe. Naronapride accelerated gastric emptying in early US clinical trials and had a comparable safety profile to placebo in those studies. The results of this study will help further develop the drug for gastroparesis, a debilitating condition with a high unmet clinical need for which there are very few long-term treatment options," said Peter Milner M.D., FACC, president and CEO.

Roland Greinwald, PhD, Managing Director of Medicine and Pharmacy at Dr. Falk Pharma GmbH, added: "The initiation of the Phase II MOVE-IT study marks an important milestone in our quest to develop an effective and safe drug for the treatment of gastroparesis Together with Renexxion Ireland, our aim is to help patients suffering from this debilitating disorder which currently lacks satisfactory treatment options."

The multicentre, pan-European Phase IIb clinical trial is being conducted under a collaborative license agreement with Dr. Falk Pharma to evaluate the efficacy, safety and tolerability of naronapride in a cohort of subjects with gastroparesis. The study will form part of the clinical development plan for the use of naronapride in gastroparesis. The main results of the phase IIb trial are expected in the first quarter of 2025.

About naronapride:

Renexxion Ireland's lead program is naronapride, a potentially best-in-class late-phase drug candidate for uncovered upper and lower GI indications. Naronapride has been shown in scientific studies to possess a unique combination of serotonin 5HT4 receptor agonist and dopamine D2 receptor antagonist properties, both clinically validated targets. Naronapride is designed to be minimally absorbable, is locally active in the intestinal lumen, and in clinical studies its side effect profile is indistinguishable from placebo. Four positive phase II studies have been completed and naronapride is ready for phase III in chronic idiopathic constipation (CIC) and gastroesophageal reflux disease (GERD).

Naronapride has been studied in 11 clinical studies and in more than 1,000 subjects to date. In these studies, naronapride has been well tolerated with a safety profile not different from that of placebo-treated patients in clinical studies. Importantly, no cardiovascular effects, including effects on heart rate, blood pressure, or ECG parameters, have been observed with naronapride in clinical studies.

About gastroparesis:

Gastroparesis is a digestive disorder characterized by delayed gastric emptying of solid foods in the absence of mechanical obstruction of the stomach, resulting in the cardinal symptoms of early satiety, postprandial fullness, nausea, vomiting, belching, and bloating. . It is now recognized as part of a broader spectrum of gastric neuromuscular dysfunction that includes impaired gastric accommodation. The total prevalent gastroparesis population in the top 7 markets is expected to increase from 33,690,400 (2017) to 36,167,100 (2030) between 2017 and 2030. 44% of the cases in the top 7 markets are in the countries Europeans.

About Renexxion Ireland:

Renexxion Ireland Limited is a privately held Irish biopharmaceutical company dedicated to supplying new medicines to patients with gastrointestinal disorders. Renexxion Ireland is collaborating with Dr. Falk to advance naronapride into late development and commercialization in Greater Europe and some other Australasian countries. (For information: https://www.prnewswire.com/news-releases/renexxion-ireland-ltd-announces-a-licensing-and-collaboration-agreement-with-dr-falk-pharma-gmbh-301392102.html) . Renexxion Ireland is currently advancing a further research program on inflammatory bowel disease.

For more information: //www.rnexltd.ie.

About Dr. Falk Pharma GmbH:

Dr. Falk Pharma GmbH has been developing and marketing innovative medicines for more than 60 years to treat a wide range of gastrointestinal disorders such as inflammatory bowel disease or eosinophilic oesophagitis, as well as hepatobiliary disorders such as primary biliary cholangitis. As international experts in digestive and metabolic medicine, the company brings together physicians, scientists and patients to devise powerful new approaches to patient care. Dr. Falk Pharma is dedicated to preclinical and clinical phase research with the aim of significantly improving therapeutic practice, as well as the health and well-being of patients. As a family business with a global presence, Dr. Falk Pharma has ten subsidiaries in Europe and Australia and is continuously growing. The company is headquartered and R&D facilities in Freiburg, Germany, and its pharmaceuticals are manufactured in Europe, primarily at sites in Germany, France, Italy, and Switzerland. Dr. Falk Pharma employs around 1,000 people worldwide, including 216 in Freiburg.

For more information: https://drfalkpharma.com

Contacts: Renexxion Ireland: Catherine Pearson, Director of Operations: Press@rnexltd.ie / 353 61 539121.Dr. Falk Pharma: Roland Greinwald, PhD, Managing Director of Medicine and Pharmacy: zentrale@drfalkpharma.de / 49 761 1514-0.

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