Soleno Therapeutics, Inc. (SLNO), a clinical-stage biopharmaceutical company focused on rare diseases, announced Tuesday positive top-line results from the randomized withdrawal period of Study C602 of DCCR (Diazoxide Choline) for Prader-Willi syndrome or PWS. The company intends to submit a New Drug Application or NDA for DCCR in PWS in mid-year 2024.
In pre-market activity on Nasdaq, Soleno shares were surging around 343 percent to trade at $19.62.
Study C602 is a long-term treatment study of DCCR (Diazoxide Choline) extended-release tablets for the treatment of PWS.
The study met its primary endpoint. It reported highly statistically significant difference in change from baseline in hyperphagia-related behaviors as assessed by the hyperphagia questionnaire for clinical trials (HQ-CT), a caregiver-completed nine item validated questionnaire for assessing hyperphagia in PWS.
Soleno further said it had entered into a Securities Purchase Agreement with Nantahala Capital Management, LLC, Abingworth LLP and Vivo Capital, LLC in December 2022, which may result in gross proceeds to Soleno of up to $60 million. To date, Soleno has received $10 million in exchange for Tranche A and Tranche B warrants to purchase common stock.
Under the deal terms, the investors are required to exercise Tranche A warrants to purchase 8,598,870 shares of common stock at $1.75 for a total of around $15 million within 30 days of the announcement of positive top-line data from the randomized withdrawal period of Study C602.
Anish Bhatnagar, Chief Executive Officer of Soleno, said, "We are delighted with the highly statistically significant results from the randomized withdrawal phase of Study C602. These results will support our planned submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) mid-year of next year. …..We remain committed to the goal of delivering DCCR, if approved, as an effective and safe therapy to individuals with PWS as expeditiously as possible."
The FDA previously acknowledged that data from this study have the potential to support an NDA submission for DCCR, which has Orphan Drug designation for the treatment of PWS in the U.S. and E.U. and Fast Track designation from the FDA.
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