Prometic reports Phase II data for PBI-4050 in Alstrom syndrome

In September, Prometic Life Sciences Inc. (TSX:PLI; OTCQX:PFSCF) reported data from 8 patients with Alstrom syndrome in a Phase II trial showing that oral PBI-4050 decreased liver stiffness, as measured by FibroScan, to a median of 5.8 from 8.5 (p=0.0098). Additionally, PBI-4050 decreased 5 markers of kidney damage in the urine, and decreased liver enzymes in patients whose levels were elevated at baseline.

The company said a DSMB and the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) have approved 2 successive treatment extensions. The duration of treatment has been extended to 72 weeks from the original 24 weeks. The open-label, U.K. trial is evaluating once-daily doses of 800 mg PBI-4050. The primary endpoint is safety. Secondary endpoints will evaluate metabolic syndrome parameters, biomarkers, effect on anti-diabetic treatment, histological appearance in fat biopsies, global metabolome, microdialysate fractions, liver stiffness and fat content...