Dr. Falk Pharma GmbH

The company has unveiled significant findings from its first-in-human phase 1 trial of KNS366, its leading drug candidate. The trial focused on assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of KNS366 in healthy adult participants. KMO, an enzyme pivotal in the kynurenine pathway of tryptophan metabolism, plays a crucial role in converting kynurenine into 3-hydroxykynurenine (3-HK). By inhibiting KMO activity, KNS366 aims to mitigate elevated 3-HK levels, thereby averting excessive tissue damage and immune system dysregulation during inflammation. According to the results, all doses of KNS366 were deemed safe and exhibited excellent tolerability. Moreover, pharmacodynamic measures showcased KNS366's potency as a KMO enzyme inhibitor, with a notable reduction in the enzyme product 3-HK. Dr. Damian Mole, is the founder and chief scientific officer (CSO) of Kynos Therapeutics, told OSP about the significance of the phase 1 data. He said: “The headline data from this phase I study have demonstrated KNS366 is safe and well tolerated at exposures that resulted in a high level of KMO enzyme inhibition. Information from the study, including pharmacodynamic measures, enables the selection of doses for future clinical studies in patients.” Kynos says this phase 1 trial represents a crucial step forward in advancing KNS366 as a potential therapeutic option for inflammatory disorders. With promising safety and efficacy profiles, KNS366 holds promise for future clinical studies aimed at addressing unmet medical needs in patients with acute and chronic inflammatory conditions. googletag.cmd.push(function () { googletag.display('text-ad1'); }); Jonathan Savidge, CEO of Kynos Therapeutics, is optimistic about the trial's outcomes: He said: “The successful completion of this Phase I study is a significant milestone for Kynos and the results provide an excellent basis for further development of KNS366. The full analysis of the wealth of data from the study will generate invaluable information on this first-in-class mechanism to enable the optimization of the further clinical development pathway. We appreciate the funding contribution from Innovate UK to conduct this important clinical trial.” Manifesting across various bodily systems, chronic inflammatory diseases encompass afflictions affecting the digestive system, joints, skin, respiratory tract, and internal organs. While these conditions lack a definitive cure, treatment strategies typically involve the administration of nonsteroidal anti-inflammatory drugs (NSAIDs), disease-modifying antirheumatic drugs (DMARDs), and lifestyle interventions. Although incurable, effective management of symptoms and complications through tailored treatment regimens remains pivotal in enhancing the quality of life for individuals grappling with chronic inflammatory diseases. Chronic inflammatory diseases encompass a diverse array of conditions characterized by persistent inflammation within the body. These diseases can extend their reach beyond localized inflammation to affect vital organs, including segments of the digestive tract, the cardiovascular system, and the respiratory system. Certain inflammatory disorders, such as specific forms of arthritis, may manifest with additional complications, including vision impairment.

EDINBURGH, United Kingdom, April 22, 2024 (GLOBE NEWSWIRE) -- Kynos Therapeutics Ltd, a clinical-stage biotechnology company developing first-in-class small molecule kynurenine 3-monooxygenase (KMO) inhibitors for acute and chronic inflammatory disorders, today announces the key findings from the first-in-human Phase I trial of its lead drug candidate, KNS366. KMO is an enzyme that acts at a key point in the kynurenine pathway of tryptophan metabolism, converting kynurenine into 3-hydroxykynurenine (3-HK). By inhibiting KMO activity, KNS366 is designed to reduce elevated 3-HK in order to prevent excess tissue damage and dysregulation of the immune system occurring during inflammation. The Phase I study of KNS366 was a randomized, double-blind, placebo-controlled dose escalation study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of KNS366 in healthy adult participants. During the multiple dose part, KNS366 was administered over seven days. All doses of KNS366 were safe and the molecule showed excellent tolerability. Pharmacodynamic measures clearly demonstrated KNS366 is a potent inhibitor of the KMO enzyme, with a high level of inhibition achieved as demonstrated by a substantial reduction in the enzyme product 3-HK. Kynos Therapeutics founder and CSO Damian Mole said, “The headline data from this Phase I study have demonstrated KNS366 is safe and well tolerated at exposures that resulted in a high level of KMO enzyme inhibition. Information from the study, including pharmacodynamic measures, enables the selection of doses for future clinical studies in patients. To our knowledge, this is the first time a KMO inhibitor has been administered across multiple days resulting in sustained KMO inhibition in humans. We are, therefore, also able to generate information on the biological pathways impacted by this mechanism in humans, through an ongoing exploratory biomarker analysis as a valuable tool to inform further clinical development.” Kynos Therapeutics CEO Jonathan Savidge said, “The successful completion of this Phase I study is a significant milestone for Kynos and the results provide an excellent basis for further development of KNS366. The full analysis of the wealth of data from the study will generate invaluable information on this first-in-class mechanism to enable optimization of the further clinical development pathway. We appreciate the funding contribution from Innovate UK to conduct this important clinical trial.” About Kynos Therapeutics – Kynos Therapeutics is a clinical-stage private company developing an innovative pipeline of first-in-class kynurenine 3-monooxygenase (KMO) inhibitors. KMO plays a major role in the regulation of inflammation, acting at the interface between inflammation, immunity and metabolism, and inhibition of KMO has therapeutic potential in both acute inflammatory conditions such as acute kidney injury and acute pancreatitis and in chronic immuno-inflammatory disorders. Spun out from the University of Edinburgh, Kynos leverages a decade of drug discovery research on KMO inhibitors originally co-developed through a collaboration between GSK and the University of Edinburgh and now exclusively licensed to Kynos. Based in Edinburgh, UK, the company is backed by founding investor Epidarex Capital as well as IP Group plc and Scottish Enterprise with additional non-dilutive funding from Innovate UK. Follow us on LinkedIn - For further information please contact: At the Company Jonathan Savidge, CEO, Kynos Therapeutics E: admin@kynostx.com Media enquiries: Sue Charles, Charles Consultants T: +44 (0)7968 726585 E: sue@charles-consultants.com

March 27, 2024 -- Renexxion Ireland Limited (“Renexxion”), a private biopharmaceutical company committed to delivering innovative drugs to patients with high unmet need in gastrointestinal (“GI”) disorders, and European partner, Dr. Falk Pharma GmbH (“Dr. Falk Pharma”), announce U.S Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application for naronapride to treat patients with gastroparesis. Naronapride is a potential best-in-class oral, locally acting pan-GI prokinetic, which 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. Renexxion and Dr. Falk Pharma will now expand patient enrollment for the ongoing global multi-center 320 patient placebo-controlled Phase 2b MOVE-IT study in gastroparesis to clinical sites in the United States (ClinicalTrials.gov ID: NCT05621811). Topline results for the Phase IIb trial are expected in mid-2025. Gastroparesis is a serious chronic disorder characterized by delayed gastric emptying leading to upper gastrointestinal symptoms such as nausea, vomiting or bloating and is often caused by diabetes. It is an underdiagnosed condition with approximately 5.6 million people in the U.S. and 4.9 million people in the European Union, UK and Australia having symptoms consistent with gastroparesis. Current treatments for gastroparesis consist of prokinetic and anti-emetic medications which have limited efficacy and off-target side effects. Metoclopramide, a D2 antagonist, is the only drug approved by the FDA for treatment in the U.S. and has a black-box warning. Naronapride is a potential solution for this large and underserved patient population due to its validated dual-action therapeutic mechanism and its favorable safety profile that has been demonstrated across four Phase 2 trials. Furthermore, naronapride has already demonstrated dose-dependent accelerated gastric emptying in a GI transit study of healthy human volunteers. “Following the receipt of a May Proceed Letter and IND clearance from the FDA, we are pleased to be assisting our European partner, Dr. Falk Pharma, with conducting its multi-center Phase 2b MOVE-IT study in gastroparesis by expanding it to clinical sites in the U.S.,” said Dr. Peter Milner M.D., FACC, Chairman and CEO of Renexxion. “Gastroparesis is becoming more prevalent globally, mainly as a consequence of rising cases of diabetes. Furthermore, the use of GLP-1 agonists in patients with obesity and obesity-related medical problems is surging and causing GI side effects consistent with symptomatic delayed gastric emptying, where prokinetics may be useful as an adjunct therapy. We are eager to accelerate the clinical development of naronapride to potentially satisfy the large unmet need for a safe and effective prokinetic, addressing the growing number of patients with delayed gastric emptying.” Dr. Kai Pinkernell, MD, Managing Director, Science & Innovation at Dr. Falk Pharma, added, “We are pleased to further advance our Phase 2b study in gastroparesis in close collaboration with our partner Renexxion, following this IND clearance from the FDA. We are aligned in our belief in the transformative power of naronapride to revolutionize treatment for gastroparesis patients and its ability to reshape the gastroparesis treatment landscape.” 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 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 H2 2024 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”). Renexxion Ireland Limited, a wholly owned Irish subsidiary of California-based Renexxion, LLC, is a privately held biopharmaceutical company committed to delivering new drugs to patients with GI disorders. In addition to developing its lead product candidate, naronapride, Renexxion Ireland is currently advancing an additional research program in inflammatory bowel disease (“IBD”). Further information on Renexxion Ireland can be found online: http://www.rnexltd.ie. 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 employs approximately 1250 individuals globally, thereof 294 in Freiburg. The content above comes from the network. if any infringement, please contact us to modify.