Компания Epicyt Pharma объявила о положительных результатах первых клинических испытаний препарата BAFA для пациентов после бариатрической операции

Шведская биотехнологическая компания Epicyt Pharma представила данные фазы 1/2a исследования, показавшие, что новый пероральный препарат BAFA значительно снижает выведение кальция с мочой у пациентов, перенесших операцию шунтирования желудка. На основе этих encouraging результатов фармацевтический гигант планирует запустить препарат в фазу 2b разработки для решения проблемы нарушения кальциевого обмена после бариатрических вмешательств.

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Epicyt Pharma reports positive results in first-in-human study of BAFA in patients following gastric bypass surgery

News provided by Epicyt Pharma AB Sep 08, 2026, 04:17 ET GOTHENBURG, Sweden, Sept. 8, 2026 /PRNewswire/ -- Epicyt Pharma AB, a Gothenburg-based clinical-stage biopharmaceutical company developing therapies for impaired intestinal calcium uptake, today announced positive topline results from its Phase 1/2a first-in-human study of BAFA in patients following Roux-en-Y gastric bypass (RYGB) surgery. The study demonstrated a statistically significant reduction in urinary calcium excretion together with improvements in key biomarkers of calcium homeostasis. Based on these encouraging findings, Epicyt is preparing to advance BAFA into Phase 2b development. "In our short proof-of-concept study aimed at showing an immediate calcium balance-effect of our drug candidate, BAFA produced coherent biological effects on markers of calcium homeostasis," says Dr. Ville Wallenius, MD, PhD, Adjunct Professor of Surgery at the University of Gothenburg and Principal Investigator. "Current post-bypass treatment focuses on supplementation of calcium and vitamin D. BAFA represents a fundamentally different approach, improving the body's ability to maintain calcium balance." BAFA is a first-in-class oral drug candidate combining a bile acid and a short-chain fatty acid to enhance intestinal calcium uptake. The Phase 1/2a study, completed in March 2026, demonstrated a statistically significant reduction in urinary calcium excretion together with improvements in key biomarkers of calcium homeostasis, consistent with improved intestinal calcium uptake. RYGB is an effective treatment for severe obesity but often leads to impaired calcium uptake, which can contribute to secondary hyperparathyroidism (over-active parathyroid glands), decreased bone density and increased fracture risk. Despite routine supplementation with calcium and vitamin D, an unmet need for therapies that improve calcium homeostasis after bariatric surgery remains. Approximately 3.5 million people in EU and US live with impaired calcium homeostasis following gastric surgery to treat obesity, with approximately 250,000 new patients added annually. For further information: Anders Rabbe, CEO, Epicyt Pharma AB Email: [email protected] www.epicyt.com About Epicyt Pharma Epicyt Pharma is a Gothenburg-based, clinical-stage pharmaceutical company developing first-in-class therapies targeting impaired intestinal calcium uptake – an overlooked driver of metabolic bone disease. The company holds worldwide rights to BAFA and is advancing its lead drug candidate in patients who have undergone Roux-en-Y gastric bypass surgery. This information was brought to you by Cision http://news.cision.com https://news.cision.com/epicyt-pharma-ab/r/epicyt-pharma-reports-positive-results-in-first-in-human-study-of-bafa-in-patients-following-gastric,c4392654 The following files are available for download: https://mb.cision.com/Main/24337/4392654/4254590.pdf | Press release (PDF) https://news.cision.com/epicyt-pharma-ab/i/epicyt-pharma-260908-press-image,c3562568 | Epicyt Pharma 260908 Press Image