Jazz Pharmaceuticals Provides Update on Phase 2b Trial of Investigational Suvecaltamide (JZP385) in Essential Tremor
Jazz Pharmaceuticals has announced the top-line results from their Phase 2b clinical trial for suvecaltamide (JZP385), targeting essential tremor (ET). The study did not achieve statistical significance at 30mg versus placebo on primary and key secondary endpoints. Noteworthy, numeric improvements were observed, although they were not statistically significant. The placebo group showed higher-than-expected improvements, surpassing those in the previous T-CALM trial. The drug was well tolerated with a consistent safety profile and no new safety signals. Common adverse events included dizziness, headache, paresthesia, diarrhea, and insomnia, mostly mild to moderate. Jazz is analyzing the data to understand the results better and is awaiting results from a trial on Parkinson's disease tremor expected in Q1 2025.
- None.
- Suvecaltamide did not achieve statistical significance at 30mg versus placebo in primary and key secondary endpoints.
- Higher-than-expected placebo improvement may complicate future trials.
- A serious adverse event related to treatment was reported.
Insights
The recent update on the Phase 2b trial of suvecaltamide (JZP385) for essential tremor represents a significant point of analysis for stakeholders. The drug did not achieve statistical significance in improving the primary and key secondary endpoints. From a clinical perspective, this is a setback as it indicates the drug might not be effective at the 30mg dose for this specific condition.
The numeric improvements observed, despite not reaching statistical significance, suggest there could be some underlying activity of the drug. This might warrant further investigation at different doses or in combination therapies. Additionally, the high placebo response noted could indicate a strong psychological component in the treatment of essential tremor, which is a factor that has complicated many clinical trials in the past.
For retail investors, it's notable that essential tremor remains a significant unmet need and these results may impact Jazz Pharmaceuticals' ability to capitalize on this segment in the short term. The ongoing Phase 2 trial in Parkinson's disease tremor will be important in determining the future of suvecaltamide. If successful, it could offset the current disappointment and provide a new direction for the drug.
Jazz Pharmaceuticals’ recent trial results for suvecaltamide can have immediate financial implications. The lack of statistically significant results in the Phase 2b trial could lead to investor concern about the company's R&D pipeline and potential future revenue streams from suvecaltamide. This news might result in a negative sentiment reflected in the stock price in the short term.
However, the fact that the drug was well-tolerated with a favorable safety profile implies that it could still be viable for other indications, such as Parkinson's disease tremor, which is currently under investigation. Investors should carefully monitor upcoming clinical data expected in the first quarter of 2025, as positive results could reinvigorate investor confidence and lead to a rebound in stock value.
Long-term investors should also consider the broader portfolio of Jazz Pharmaceuticals. While this setback is notable, the company's diverse pipeline and existing product portfolio provide some cushion against this single trial's impact.
While not statistically significant, numeric improvements were observed on the primary endpoint and key secondary endpoint at 30mg versus placebo. The improvement in placebo from baseline to week 12 also exceeded the Company's expectations and was higher than what was observed for placebo in the prior T-CALM trial of suvecaltamide.
"We are disappointed that the trial did not meet its primary endpoint. We recognize the significant unmet need for people living with ET, and we are grateful to the patients, their families and the investigators that participated in the trial," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals. "We are evaluating the data to better understand the trial results and await the results of the suvecaltamide trial in Parkinson's disease tremor to determine next steps for the program. The Phase 2 Parkinson's disease tremor trial is ongoing with results expected first quarter 2025."
Suvecaltamide was well tolerated and the overall safety profile was consistent with previous studies with no new safety signals observed. The most common treatment-emergent adverse events (TEAEs) were dizziness, headache, paresthesia, diarrhea and insomnia. These were predominately mild to moderate in severity. One participant experienced a serious adverse event considered treatment related by the investigator.
About the Phase 2b Trial
The Phase 2b clinical trial (NCT05122650) is a 12-week, multicenter, double-blind, randomized, placebo-controlled trial evaluating the efficacy and safety of suvecaltamide in a once-daily oral dose of 10, 20 and 30mg or placebo. The primary endpoint (modified TETRAS composite outcome score) represents items 1-11 from the TETRAS-ADL combined with items 6+7 (spiral and handwriting assessments, respectively) from the TETRAS-PS with scoring modifications. The key secondary endpoint in the trial measured the percentage of participants with ≥1 point improvement on CGI-S. The trial randomized 420 participants from four countries.
About Suvecaltamide
Suvecaltamide (JZP385) is an investigational, highly selective and state-dependent modulator of T-type calcium channels (Cav3). T-type calcium channels play a role in the brain's control of muscle movement.1 Suvecaltamide preferentially binds to stabilize a specific conformation of the channel and reduce activity. The suvecaltamide Phase 2 proof-of-concept trial in Parkinson's disease tremor is ongoing (NCT05642442).
About Jazz Pharmaceuticals
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in
Caution Concerning Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to potential timing of data availability from the JZP385 trial in Phase 2 Parkinson's disease tremor and other statements that are not historical facts. These forward-looking statements are based on Jazz Pharmaceuticals' current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with pharmaceutical product development, and other risks and uncertainties affecting Jazz Pharmaceuticals and its development programs, including those described from time to time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals plc's Securities and Exchange Commission filings and reports (Commission File No. 001-33500), including Jazz Pharmaceuticals' Annual Report on Form 10-K for the year ended December 31, 2023, as supplemented by our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, and future filings and reports by Jazz Pharmaceuticals. Other risks and uncertainties of which Jazz Pharmaceuticals is not currently aware may also affect Jazz Pharmaceuticals' forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof or as of the dates indicated in the forward-looking statements, even if they are subsequently made available by Jazz Pharmaceuticals on its website or otherwise. Jazz Pharmaceuticals undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made.
Media Contact:
Kristin Bhavnani
Head of Global Strategic Brand Engagement
Jazz Pharmaceuticals plc
CorporateAffairsMediaInfo@jazzpharma.com
Investors:
Andrea N. Flynn, Ph.D.
Vice President, Head, Investor Relations
Jazz Pharmaceuticals plc
InvestorInfo@jazzpharma.com
References:
1 Papapetropoulos S,
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SOURCE Jazz Pharmaceuticals plc
FAQ
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