SK Biopharm Milestone Gains in Tech Transfer Pipeline
Solriamfetol Phase III Clinical Trial Results Show Promise for Adult ADHD Treatment
Table of Contents
- Solriamfetol Phase III Clinical Trial Results Show Promise for Adult ADHD Treatment
- Solriamfetol for Adult ADHD: Your Top Questions Answered
- What is Solriamfetol, and What is it Being Studied For?
- What Do the Phase III Clinical Trial Results Show?
- what Were The key Findings of the Solriamfetol Clinical Trial?
- How Does Solriamfetol compare to Placebo in Treating ADHD Symptoms?
- Is Solriamfetol Safe?
- how is Solriamfetol Being Developed and Marketed?
- How Will These Results Impact the Future Availability of Solriamfetol?
- Summary of Key Findings:
SK Biopharm partner announces positive top-line results, potentially triggering milestone payment.
Top-line results from a Phase III clinical trial of solriamfetol for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults have been released. The study, involving a compound licensed by SK Biopharm, suggests potential improvements in ADHD symptoms and a favorable safety profile.
According to a statement from the pharmaceutical industry,Liquid Therapeutics,a U.S.-based company that in-licensed solriamfetol from SK Biopharm, announced the results after completing the Phase III trial. The company reported that the trial met key primary and secondary endpoints.
Study Details
The Phase III clinical trial involved 516 adults diagnosed with ADHD. The randomized,double-blind,placebo-controlled study was conducted at multiple sites across the United States. Participants were administered either 150 mg of solriamfetol, 300 mg of solriamfetol, or a placebo once daily for six weeks.
The primary endpoint of the trial was the change from baseline in the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score. The key secondary endpoint was the change from baseline in the Clinical Global Impression-Severity (CGI-S) score.
Key Findings
Results from the clinical trial indicated that the 150 mg dose of solriamfetol resulted in an average decrease of 17.7 points from baseline on the AISRS scale, compared to a 14.3-point decrease in the placebo group.This difference was statistically notable. Improvements in ADHD symptoms were observed as early as the first week of treatment, with an average symptom reduction of 45% after six weeks.
Furthermore, the clinical response rate was higher in the solriamfetol group. Approximately 53.5% of patients in the solriamfetol group experienced a reduction of 30% or more in their total AISRS score, compared to 41.3% in the placebo group.
The CGI-S score also showed a statistically significant reduction in the 150 mg solriamfetol group, indicating a decrease in the severity of ADHD. Though, the 300 mg solriamfetol group showed enhancement similar to the placebo group, and statistical significance was not confirmed at this dosage.
Regarding safety, solriamfetol demonstrated consistent tolerability, and the incidence of adverse events was dose-dependent. No significant adverse reactions were reported, according to Liquid Therapeutics.
Potential Milestone Payment
The positive results from the solriamfetol clinical trial may trigger a milestone payment to SK Biopharm. SK Biopharm originally licensed solriamfetol to ARL Bio Pharma in 2011. Later, through Jazz Pharmaceuticals, Liquid Therapeutics acquired the rights to the compound.
Solriamfetol was initially developed as a treatment for sleep disorders but is currently undergoing clinical trials to expand its indications to include ADHD and major depressive disorder (MDD).
Typically,technology transfer agreements include provisions for additional milestone payments upon the expansion of indications or the achievement of clinical development milestones.
The contents of the contract cannot be disclosed in detail, but the milestone you receive can increase.
Solriamfetol for Adult ADHD: Your Top Questions Answered
Are you or a loved one struggling with adult ADHD? Recent clinical trial results on solriamfetol offer promising news. Let’s explore what these findings mean, answering your most pressing questions.
What is Solriamfetol, and What is it Being Studied For?
Solriamfetol is a medication initially developed for sleep disorders. However, it’s now being investigated for its potential to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in adults. The ongoing Phase III clinical trials aim to assess its effectiveness and safety in managing ADHD symptoms.
What Do the Phase III Clinical Trial Results Show?
Top-line results from the phase III clinical trial of solriamfetol for adult ADHD have been released. The study demonstrated positive outcomes, suggesting improvements in ADHD symptoms and a favorable safety profile. The trial met its key primary and secondary endpoints.
what Were The key Findings of the Solriamfetol Clinical Trial?
The Phase III clinical trial involved 516 adults diagnosed with ADHD. Participants received either 150 mg of solriamfetol, 300 mg of solriamfetol, or a placebo once daily for six weeks. Key findings include:
symptom Reduction: The 150 mg dose of solriamfetol resulted in an average decrease of 17.7 points from baseline on the Adult ADHD Investigator Symptom Rating Scale (AISRS), compared to a 14.3-point decrease in the placebo group.
Early Improvements: Improvements in ADHD symptoms were observed as early as the first week of treatment, with an average symptom reduction of 45% after six weeks.
Clinical Response Rate: Approximately 53.5% of patients in the solriamfetol group experienced a reduction of 30% or more in their total AISRS score,compared to 41.3% in the placebo group.
Severity Reduction: The CGI-S score also showed a statistically significant reduction in the 150 mg solriamfetol group, indicating a decrease in the severity of ADHD.
How Does Solriamfetol compare to Placebo in Treating ADHD Symptoms?
The trial clearly showed solriamfetol’s effectiveness compared to a placebo. The 150 mg dose of solriamfetol resulted in a statistically significant reduction in ADHD symptoms. Specifically:
AISRS Score: The 150 mg dose showed a greater reduction in the AISRS score compared to the placebo.
Clinical Response: A higher percentage of patients in the solriamfetol group experienced significant symptom reduction.
Is Solriamfetol Safe?
Safety data from the trial indicates that solriamfetol demonstrated consistent tolerability. The incidence of adverse events was dose-dependent, and no significant adverse reactions were reported. The positive safety profile is an significant factor in evaluating the potential of solriamfetol for treating adult ADHD.
how is Solriamfetol Being Developed and Marketed?
The rights to solriamfetol are currently held by Liquid Therapeutics, a U.S.-based company. The compound was originally licensed from SK Biopharm, which may receive milestone payments based on the positive clinical trial results. Solriamfetol was initially investigated for sleep disorders but has been expanded to include ADHD and major depressive disorder (MDD).
How Will These Results Impact the Future Availability of Solriamfetol?
The positive results from the Phase III clinical trial may trigger a milestone payment to SK Biopharm. The prosperous completion of the trial increases the likelihood that solriamfetol will become available as a new treatment option for adults with ADHD. This will depend on further regulatory review and approval processes.
Summary of Key Findings:
| Feature | 150 mg Solriamfetol Group | Placebo Group |
| ——————- | ————————- | ———————– |
| AISRS Score Change | -17.7 points | -14.3 points |
| Symptom Reduction at 6 Weeks | 45% | N/A |
| Clinical Response (≥30% Reduction) | 53.5% | 41.3% |
| CGI-S Score | Statistically Significant Reduction | No Significant Reduction |