Soleno Therapeutics Faces Class Action Lawsuit Over Alleged Clinical Trial Integrity Issues for Prader-Willi Syndrome Drug
核心洞察
Soleno Therapeutics faces a securities class action lawsuit alleging systematic problems in Phase 3 clinical trials for DCCR (VYKAT XR (搜索)), their FDA-approved treatment for hyperphagia (搜索) in Prader-Willi syndrome (搜索) patients.
The lawsuit claims the pivotal randomized withdrawal study enrolled only 77 participants with enrollment skewed toward a single site, while the original 13-week Phase 3 trial failed to meet its primary endpoint.
Investigators allegedly identified placebo bias from unblinding caused by visible side effects and expressed sharp criticism of trial conduct, with many indicating no plans to prescribe the drug.
Soleno Therapeutics, Inc. (NASDAQ: SLNO) is facing a securities class action lawsuit alleging the company conducted flawed clinical trials for its sole commercial product, DCCR (marketed as VYKAT XR (搜索)), a diazoxide choline extended-release tablet approved by the FDA for treating hyperphagia (搜索) in patients with Prader-Willi syndrome (搜索). The lawsuit, filed by Levi & Korsinsky (搜索), LLP, seeks damages for investors who purchased Soleno securities between March 26, 2025 and November 4, 2025.
Clinical Trial Deficiencies Alleged
The complaint centers on alleged systematic problems in Soleno's Phase 3 clinical trial program, which formed the basis for DCCR's FDA approval. According to the lawsuit, the pivotal randomized withdrawal study enrolled only 77 participants, representing an unusually small sample size, with enrollment allegedly skewed heavily toward a single clinical site.
The original 13-week Phase 3 trial, known as DESTINY PWS with 127 participants, failed to meet its primary endpoint for hyperphagia (搜索) improvement, according to the filing. The lawsuit alleges that investigators identified placebo bias resulting from unblinding caused by visible side effects including hypertrichosis (搜索) (excessive hair growth) and edema (搜索), as well as differing smell between the drug and placebo.
Investigator Concerns and Safety Issues
According to the complaint, many investigators interviewed by an independent research firm expressed sharp criticism of trial conduct and indicated they had no plans to prescribe the drug. A number of endocrinologists across major academic centers and PWS clinics reportedly expressed similar skepticism about the drug's safety profile.
The lawsuit claims defendants obscured a linear increase in prediabetes (搜索) and diabetes (搜索) markers over three years of treatment with no plateau, raising concerns about long-term metabolic effects.
Fluid Retention and Safety Concealment Allegations
The complaint details that fluid retention is inherent to diazoxide's mechanism of action. According to the lawsuit, two patients in the 13-week Phase 3 trial may have been admitted for symptoms consistent with pulmonary edema (搜索) and potential heart failure (搜索), but these events were allegedly downplayed by the company.
The lawsuit chronicles how the prevalence of edema (搜索) appeared to increase the longer patients used the drug, with no apparent plateau, suggesting a potential tipping point between discontinuation or a serious safety event. Despite these concerns, the complaint alleges that management repeatedly told investors the drug had a "well-established safety profile" and that "no new safety signals" had emerged in the postmarketing setting.
Legal Implications
Joseph E. Levi, Esq., representing the plaintiffs, stated: "The complaint raises serious questions about whether investors received accurate information regarding the integrity of the clinical data underpinning DCCR's approval and commercial launch."
The lawsuit contends that Soleno's entire commercial opportunity for DCCR hinged on the randomized withdrawal period of Study C602. If that study's data was unreliable, according to the complaint, the foundation for the drug's approval, its commercial launch, and Soleno's revenue was fundamentally compromised.
Investors have until May 5, 2026 to seek lead plaintiff status in the class action lawsuit. The case highlights the critical importance of clinical trial integrity in pharmaceutical development and the potential consequences when trial conduct is called into question.