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.

Clinical development plan for BAFA

First in man trial, EPGB001
– Proof of principle-study/Phase I/IIa

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.

Also, a number of bone markers were measured.

The study results were, albeit only 2 weeks treatment, positive showing a significantly increased absorption of calcium i.e. decreased excretion of calcium in urine. Bone markers signaled a decreased breakdown of bone.

Epicyt Pharma is now planning for a Phase 2b study.

Intellectual Property and patents

National phase patent applications were filed starting 2020. Refer to a combination of BAFA + calcium and vitamin D as well as BAFA alone. The patent family has a geographically broad coverage with approved claims in most countries.

Potential patent protection until 2038, excluding extensions.

The company is expanding the patent portfolio with new families.