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Soleno Therapeutics Completes Enrollment in Randomized Withdrawal Period of Study C602 of DCCR for Prader-Willi Syndrome
Top-line data expected in Q3 2023 and has the potential to support an NDA submission for DCCR in Prader Willi Syndrome Enrollment completion satisfies closing
About this update from Soleno Therapeutics, Inc.
[{"type":"text","content":"Top-line data expected in Q3 2023 and has the potential to support an NDA submission for DCCR in Prader Willi Syndrome Enrollment completion satisfies closing condition on December 2022 Securities Purchase Agreement and triggers $10 million capital infusion REDWOOD CITY, Calif., May 03, 2023 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that it has completed enrollment in the randomized withdrawal period of Study C602, a long-term treatment study of DCCR (Diazoxide Choline) Extended-Release tablets for the treatment of Prader-Willi syndrome (PWS). The U.S. Food and Drug Administration (FDA) previously acknowledged that data from the study has the potential to support a New Drug Application (NDA) submission for DCCR. “We are pleased that enrollment in the randomized withdrawal period of Study C602 is now complete,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics. “We would like to thank the participants, their families and the study sites for helping us reach this significant milestone for our late-stage DCCR program. Furthermore, it enables the Company to receive $10 million under the Securities Purchase Agreement executed in December 2022, which will support clinical operations through top-line data leading to a potential NDA filing and approval of DCCR. We continue to expect top-line results in the third quarter of 2023.” The randomized withdrawal period of Study C602 is a multi-center, randomized, double-blind, placebo-controlled study of DCCR that enrolled 77 patients with PWS at 17 sites in the U.S. and 5 sites in the U.K. The randomized withdrawal period consists only of patients previously enrolled in Study C602, with 93% of the total 83 patients participating, which was inline with expectations. Participants were randomized to receive either DCCR or placebo for a period of four months. Soleno 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 the Company of up to $60 million (the Securities Purchase Agreement). Under the terms of the Securities Purchase Agreement, the investors committed to pay $10 million in exchange fo...