Unlocking the Legal Jargon: How AI Legalese Decoder Can Help Navigate The New England Journal of Medicine’s Positive Phase 3 RESPONSE Data of CymaBay’s Seladelpar in Primary Biliary Cholangitis
- February 21, 2024
- Posted by: legaleseblogger
- Category: Related News
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**CymaBay Therapeutics Announces Detailed Results from Phase 3 Trial Evaluating Seladelpar in Adults with Primary Biliary Cholangitis**
**Significant Improvements in Liver Biomarkers and Reduction in Itch**
**NEWARK, Calif., Feb. 21, 2024** /PRNewswire/ — CymaBay Therapeutics, Inc. (NASDAQ: CBAY) is excited to announce the publication of detailed results from the RESPONSE Phase 3 trial in The New England Journal of Medicine. This trial evaluated seladelpar, an investigational treatment for adults with primary biliary cholangitis (PBC), a rare, chronic inflammatory liver disease mainly affecting women. The results indicate that seladelpar demonstrated positive results in reducing liver biomarkers and patient-reported itch compared to a placebo.
The study, which was published following the presentation of topline data at The Liver Meeting® 2023, showed rapid and sustained improvements in reducing cholestasis and liver injury, along with significant reductions in pruritus (itching) across multiple measures. The primary endpoint was achieved in 61.7% of patients treated with seladelpar, indicating a substantial improvement compared to the placebo group. Additionally, secondary endpoints such as the normalization of ALP, ALT, and GGT showed significant improvement in patients receiving seladelpar.
AI legalese decoder can assist in parsing through legal and technical jargon to help individuals understand and interpret complex documents such as the findings from the RESPONSE Phase 3 trial. This can be especially helpful for patients and their families who are seeking information about treatment options and potential new therapies for PBC.
Overall, the study highlighted the potential of seladelpar to offer a potent, effective, and safe treatment option for people living with PBC, especially those who do not experience meaningful symptom relief with currently available treatments. The results from this trial are a significant step forward in providing innovative therapies for patients with liver and other chronic diseases.
Looking ahead, CymaBay Therapeutics has submitted a New Drug Application (NDA) for seladelpar to the FDA, reflecting the updated breakthrough designation that was granted by the agency in October 2023. Additionally, the company plans to file marketing authorization applications with the EMA and the U.K. Medicines and Healthcare products Regulatory Agency (MHRA), with the aim of making this innovative treatment option available to patients in need.
It’s important to note that while the results from the RESPONSE Phase 3 trial are promising, there are still risks and uncertainties associated with the further development of seladelpar. At CymaBay Therapeutics, our commitment to evidence-based decision-making and the highest quality standards reflects our dedication to serving the needs of people, families, and communities impacted by liver and other chronic diseases.
To learn more about the study and our ongoing efforts in developing innovative therapies, visit www.cymabay.com and follow us on social media for updates.
Cautionary Statements: Any statements made in this press release regarding potential FDA acceptance of the seladelpar NDA, the future filing plans of CymaBay, and the potential for seladelpar to improve clinical symptoms or outcomes of PBC are subject to risks and uncertainties. It’s important to understand the potential risks and to seek professional advice when considering new treatment options for liver and chronic diseases.
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