KNS-366

Freiburg, 29. October 2024: Today, Dr. Falk Pharma GmbH announces the successful acquisition of Kynos Therapeutics Ltd., a clinical stage biopharmaceutical company focusing on the development of novel treatments for patients suffering from acute and chronic inflammatory diseases. The company was founded as a spin-out of the University of Edinburgh, Scotland, together with lead investor Epidarex Capital, a leading early-stage transatlantic venture fund, along with IP Group, and Scottish Enterprise. Effective immediately, Kynos Therapeutics will be integrated into the Falk Group. Kynos Therapeutics’ lead investigational asset is KNS366, a highly potent and selective first-in-class inhibitor of the enzyme kynurenine 3-monooxygenase (KMO). In a Phase I clinical trial, KNS366 was shown to be safe and well-tolerated at multiple doses. The compound also led to a dose-dependent inhibition of the enzyme KMO and modulation of its downstream metabolites. Dr. Falk Pharma is excited about the addition of KNS366 to its R&D pipeline and will further explore the potential of KNS366 in future clinical trials, initially focusing on acute pancreatitis. This new asset will enhance Dr. Falk Pharma´s expansion into rare digestive and metabolic diseases and conditions. About KNS366 Kynos Therapeutics’ lead investigational asset KNS366 selectively inhibits the enzyme kynurenine 3-monooxygenase (KMO). KMO is a key enzyme in the tryptophan metabolic pathway and has also been shown to play an important role in modulating immune processes. By inhibiting KMO activity, KNS366 interferes with inflammation and other immune system pathologies by lowering levels of its downstream metabolite – 3- hydroxykynurenine (3HK) – high levels of which have been linked to tissue damage and dysregulation of the immune system during inflammation. Inflammatory diseases including acute pancreatitis trigger an exacerbated, systemic pro-inflammatory response, making KMO inhibitors a promising next-generation treatment option for disorders characterized by severe inflammation. About acute pancreatitis Acute pancreatitis is a sudden inflammation of the pancreas that can be triggered by a number of factors. In its severe form, this acute inflammation can cascade to a reaction in the entire body over several days to weeks that can result in systemic inflammation, organ failure, and death. Accordingly, acute pancreatitis requires immediate medical intervention to manage patients’ symptoms and prevent worsening of their condition, often necessitating prolonged hospitalization. Currently, acute pancreatitis occurs in about 240,000 people in Europe and 300,000 people in the United States each year, with 1 in 5 acute pancreatitis patients requiring intensive care. To date, there are no proven or approved treatment options to prevent organ failure and death resulting from severe acute pancreatitis, meaning there is an urgent need for effective treatments. About partnering with Dr. Falk Pharma Dr. Falk Pharma engages in a variety of collaboration and partnership models to develop and deliver innovative treatment concepts with great potential. These treatments can be based on any type of pharmacological approach, from small molecules to biologics to novel drug delivery technologies. The company is involved in partnership projects across the range of phases and partners, from all stages of pre-clinical/clinical development and marketing as well as with academic researchers, start-ups, and established companies. Dr. Falk Pharma is an industry leader in innovative pharmaceutical formulations that deliver active substances to specific functional segments of the gastrointestinal tract. Many of their products have attained standard-of-care status. The company enjoys strong, long-standing collaborations with renowned clinical centres and with academic and clinical key opinion leaders in the fields of gastroenterology, hepatology and metabolic diseases. 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 hepatobiliary 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. Dr. Falk Pharma GmbH employs approximately 1250 individuals globally and 323 in Freiburg.