Breakthrough Results from Study C602
Soleno Therapeutics, Inc. (NASDAQ: SLNO), a trailblazer in the biopharmaceutical industry, recently unveiled its promising top-line results from the randomized withdrawal phase of Study C602. This pivotal study delved into the long-term therapeutic effects of DCCR (Diazoxide Choline) Extended-Release tablets, specifically targeting Prader-Willi syndrome (PWS).
Soleno CEO’s Enthusiastic Remarks
Anish Bhatnagar, M.D., the dynamic CEO of Soleno, couldn’t hide his enthusiasm about the significant outcomes of the study. “The results from the randomized withdrawal phase of Study C602 have surpassed our expectations,” he remarked. “These findings lay a robust foundation for our planned New Drug Application (NDA) submission to the U.S. FDA in the coming year.”
Bhatnagar also took a moment to acknowledge the relentless efforts of the patients, their families, investigators, study site personnel, and the advocacy community. He further highlighted the unwavering dedication of the entire Soleno team towards the DCCR development program. “Our primary objective remains to expedite the delivery of DCCR, upon approval, as a potent and safe therapeutic option for individuals grappling with PWS,” he added.
FDA’s Positive Nod
The U.S. Food and Drug Administration (FDA) has previously signaled its optimism regarding the data from this study, hinting at its potential to back an NDA submission for DCCR. Notably, DCCR has already clinched the Orphan Drug designation for PWS treatment in both the U.S. and E.U. Furthermore, it has been honored with the Fast Track designation by the FDA, underscoring its potential significance in the medical community.
In-depth Look at Study Design
Diving deeper into the study’s design, the C602 randomized withdrawal period was meticulously crafted as a multi-center, double-blind trial. It encompassed 77 patients, all of whom showcased hyperphagia-related behaviors. These behaviors were meticulously assessed using the hyperphagia questionnaire for clinical trials (HQ-CT). The findings were nothing short of remarkable, with a pronounced difference in the HQ-CT total score of 5.0 at week 16 (p=0.0022) favoring DCCR.
The secondary endpoints also painted a rosy picture, indicating a strong inclination towards the efficacy of DCCR. Moreover, the drug’s safety profile remained impeccable, with patients reporting no new or unexpected health concerns.
Financial Milestones for Soleno
On the financial front, Soleno Therapeutics made headlines in December 2022 when it forged a Securities Purchase Agreement with renowned entities like Nantahala Capital Management, LLC, Abingworth LLP, and Vivo Capital, LLC. This strategic move is anticipated to channel gross proceeds of up to $60 million into Soleno’s coffers. Following the release of the positive top-line data from Study C602, the investors are poised to exercise Tranche A warrants, translating to a windfall of approximately $15 million for Soleno.
As the biopharmaceutical world keenly watches, Soleno Therapeutics is poised to redefine the therapeutic landscape for Prader-Willi syndrome.
Disclosure: Neither Matt Rego nor Spotlight Growth have any position or relationship with any companies mentioned in this article. No payment was made to create this article. This article should not be taken as a solicitation or recommendation to buy or sell any securities. Please conduct your own research and consult your financial advisor to determine your risk tolerance and investment path. We are not licensed brokers or investment advisors.