Cyclo Therapeutics Inc (CYTH)

[Hawaii 5-0]

•VTS-270, a cyclodextrin-based drug candidate in clinical development by Mallinckrodt, did not meet its primary objective in the pivotal Phase 2b/3 trial.

https://seekingalpha.com/article/4307548-mallinckrodt-vtsminus-270-niemann-pick-disease-type-c-competition

In our recently completed registration trial, the product did not show a statistically significant separation from placebo. But importantly, neither the VTS-270 nor the placebo arm showed disease progression as would have been anticipated in a neurodegenerative condition over 52 weeks of observation.

The expectation was that both treatment groups in the study would worsen over the trial period but that the VTS-270 treated group might show an attenuated course based on an accrued benefit.

Accordingly, our review of the data from the Phase 2b/3 trial has required substantial effort and still continues. We expect a better understanding of the potential benefit of VTS-270 to emerge as we carefully consider the totality of data available to us. This is an important step.