BAFA is intended for the treatment of decreased calcium absorption after RYGB surgery
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
Two-arm study with 20 RYGB-operated women > 25 years, 6-18 months postop.
Estimated start Q2 2022, the study completion time period is about 8 months.
After a successful Scientific Advice Meeting with the Swedish Medical Products Agency (MPA), Epicyt Pharma is now planning a proof of principle study, EPGB001. The primary study objectives are safety and calcium uptake in the gut.
RYGB-operated women, 25 to 45 years of age, will be randomized to four cohorts receiving calcium and vitamin D during two weeks together with BAFA, or with Placebo. In a crossover design, after a wash out period of three weeks the participants will receive the alternative treatment. This is performed with two different doses BAFA; hence the four cohorts. The study will be double-blinded.
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.