Saniona reports data from exploratory Phase IIa of Tesomet for Prader-Willi

Saniona AB (SSE:SANION) said data from an exploratory Phase IIa trial evaluating once-daily Tesomet tesofensine/metoprolol in patients with Prader-Willi syndrome showed that plasma concentrations of tesofensine were two to four times higher compared to previous studies in obese and diabetic patients with the same tesofensine dose. Saniona said the observed plasma concentration may be explained in part by a lower metabolic rate and clearance of tesofensine in Prader-Willi patients and their high body fat percentage. There were no serious adverse events reported, but all patients in the study experienced adverse events, of which 83% were deemed possibly or probably related to treatment in the Tesomet group vs. 63% for placebo. Adverse events in the Tesomet group included exacerbation of already occurring behavioral problems and CNS disorders. Of the nine patients enrolled, four patients in the Tesomet group and one patient in the placebo group dropped out before completing the three-month trial. Saniona said the unexpectedly high tesofensine plasma concentration could explain the high drop out rate and some of the side effects.

In seven evaluable patients who completed eight weeks of treatment, Tesomet reduced mean body weight by 5% from baseline at week eight vs. 0.5% for placebo. In four patients treated for 13 weeks, mean weight loss from baseline at week 13 was 6.8% for Tesomet and 0.8% for placebo. Tesomet reduced average weight by about 4.8 kg after week eight (n=5) and 8 kg after week 13 (n=2). From baseline to week eight and 13, Tesomet reduced average waist circumference by 7.2 and 10 cm, respectively, vs. 4 and 6.5 cm for placebo...