Saniona: Interim study results presented in the Prader-Willi syndrome2018-01-08 15:42
Saniona reported earlier today results from a phase IIa study in Prader-Willi syndrome. The study was subject to interim-analyses in October 2017 since some patients discontinued the study due to adverse effects. Based on the results, a clinically meaningful weight loss as well as a reduction in hyperphagia (food craving) was reported in the study. On the other hand, plasma concentrations of tesofensine were reported to be two to four times higher as compared to previous studies with tesofensine. This may explain the high dropout and adverse effects in the study.
Saniona will now analyze the data in detail and talk to experts to evaluate on how to proceed with the clinical development plan in Prader-Willi syndrome (PWS). Although it should be emphasized that the exploratory study in the Prader-Willi syndrome (PWS) was a small study (n=9) and any interpretation of results should be read with that in mind, we find the results encouraging. Besides from reporting a positive outcome in the primary endpoint of mean change in body weight, the results revealed a decrease of Hyperphagia (food craving) in Tesomet patients. Hyperphagia decreased from 10.00 (n=6) at baseline to 1.00 (n=5) after eight weeks, and 0.00 after 13 weeks (n=2) with 0.00 being equivalent to no signs of hyperphagia as measured by the hyperphagia questionnaire. The hyperphagia questionnaire is a caregiver based questionnaire that offers a quantifiable outcome measure.
There is still some uncertainty how the clinical program within PWS will continue further. We preserve any changes to our valuation model in our next update, subsequent to Saniona’s Q4’17 interim report. There is possibly a greater clarity at that time on how to further proceed with the Tesomet program within PWS. Possible outcomes to our valuation model related to this program could be:
- Saniona deem the PWS as too difficult and discontinues the Tesomet program within this indication. As PWS represents SEK 8 of our SEK 72 base valuation, we will reduce our base valuation to SEK 64.
- Saniona decides to continue the program. Further clinical studies are required which will postpone launch year. In our valuation model, we have estimated launch year in 2021. A postpone in launch of 1 – 3 years will have a negative impact on our valuation in the interval of SEK 1,5 – 4,5.
- Saniona decides to continue the program and where we don’t make any adjustments to launch year. That will not have any negative impact on our valuation.
Although we see PWS as an important indication with high unmet medical need, there are also other eating disorders that could become of interest for Tesomet, e.g. binge eating, if PWS would discontinue. Furthermore, our valuations in other indications that Tesomet targets will not be affected by the interim-results in PWS.
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