Soleno Therapeutics Announces Successful End-of-Phase II Meeting with FDA for DCCR in Prader-Willi Syndrome
Minutes Confirm Alignment on Soleno’s Planned Phase III Clinical Trial
Soleno In Process of Initiating Phase III Study
“Alignment with the
In the fourth quarter of 2017, Soleno raised aggregate gross proceeds of approximately $15 million through a private placement of the company’s common stock in order to conduct the planned Phase III trial of DCCR in PWS.
Diazoxide choline has Orphan Drug Designation for the treatment of PWS in the US and EU.
About Diazoxide Choline Controlled-Release Tablet
Diazoxide choline controlled-release tablet is a novel, proprietary extended-release, crystalline salt formulation of diazoxide, which is administered once-daily. The parent molecule, diazoxide, as an oral suspension, has been used for decades in thousands of patients in a few rare diseases in neonates, infants, children and/or adults, but not in PWS. Soleno conceived of and established extensive patent protection on the therapeutic use of diazoxide and DCCR in patients with PWS. The DCCR development program is supported by positive data from five completed Phase I clinical studies in various metabolic indications or in healthy volunteers and three completed Phase II clinical studies, one of which was in PWS patients. In the PWS Phase II study, DCCR showed promise in addressing the hallmark symptoms of PWS, most notably hyperphagia.
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This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ability to initiate the Phase III clinical development program of DCCR in PWS in early 2018.
We may use terms such as "believes," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this presentation. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in Soleno’s Form 10-Q filed with the
Source: Soleno Therapeutics