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 a reduced absorption of calcium by 80%, already one year post surgery.

Regular supplementation of vitamin D and calcium has an insufficient effect in RYGB-patients when the presence of activated receptors in the small intestinal wall is low. BAFA has the potential to increase the uptake of calcium by activating vitamin D receptors in those individuals who have a decreased presence of bile acid and fatty acid in the gut.

Epicyt Pharma has demonstrated that the BAFA combination 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 bile function will most likely also benefit from BAFA treatment, and may be potential label expansion 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 is now planning a proof of principle study, EPGB001. It is a single-arm study with 6 RYGB-operated women > 25 years, 6-18 months postop. The study is estimated to start 2Q2024 with data available in 3Q2024.

The primary study objectives are safety and assessment of calcium uptake in the gut measured through the clinically relevant markers of calcium absorption and body distribution, PTH (Parathyroid hormone), the hormone that regulates the calcium in bone, and the amount of calcium excreted in the urine. PTH and urinary calcium are the exploratory efficacy endpoints for the study.

Patent overview

National phase patent applications were filed starting 2020. Refers to a combination of BAFA + calcium and vitamin D as well as BAFA alone.

Potential patent protection until 2038, excluding extensions.

The company works closely with AWA Patent (Malmö, Sweden), Michael Sommer, and with Per Lindberg, an independent strategic advisor with broad experience from the pharma industry and patenting strategies.