Epicyt Pharma’s BAFA reduces urinary calcium excretion in patients following RYGB

Epicyt Pharma has announced positive topline results from its Phase 1/2a first-in-human study of BAFA, a first‑in‑class oral drug candidate combining a bile acid and a short‑chain fatty acid to enhance intestinal calcium uptake, 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,” said Dr Ville Wallenius, 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.”

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.

BAFA is intended to counteract decalcification of bone tissues thus preventing osteoporosis. BAFA, with the active substances glycocholate (a bile acid) and butyrate (a fatty acid), is intended for the treatment of decreased calcium absorption after RYGB surgery. Research shows that patients have an 80% reduced absorption of calcium already one year post surgery.

Regular supplementation of vitamin D and calcium has an insufficient effect in RYGB-patients. BAFA has the potential to increase the uptake of calcium by activating vitamin D receptors in those individuals who have a decreased intestinal uptake of calcium.

Epicyt Pharma has demonstrated that BAFA activates the vitamin D receptors in intestinal epithelial cells, which in turn increases calcium uptake. The risk of adverse reactions is considered low as the BAFA active agents occur naturally in our bodies. BAFA treatment is a replacement regimen. Other potential patient populations with impaired calcium uptake will most likely also benefit from BAFA treatment and may be potential label extension opportunities.

After a successful Scientific Advice Meeting with the Swedish Medical Products Agency (MPA), Epicyt Pharma has now performed a proof of principle study, EPGB001, a single-arm study with 6 RYGB-operated patients > 25 years, >12 months postop. Data was available in March 2026.

The primary study objectives were safety and assessment of calcium uptake in the gut measured through the clinically relevant markers of calcium excretion in urine and PTH (Parathyroid hormone), a hormone that regulates the calcium hemostasis. PTH and urinary calcium were the exploratory efficacy endpoints for the study.

The study results were, albeit only two weeks treatment, positive showing a significantly increased absorption of calcium i.e. decreased excretion of calcium in urine. Bone markers signalled a decreased breakdown of bone.