Latest news with #SegalTrials
Business Wire
07-07-2025
- Health
- Business Wire
Segal Trials Contributes to Breakthrough Flu Prevention Study Led by Cidara Therapeutics
BUSINESS WIRE)--Segal Trials proudly announces its participation in the successful Phase 2b NAVIGATE clinical trial conducted by Cidara Therapeutics, evaluating CD388 —a novel, non-vaccine, long-acting antiviral—for the prevention of seasonal influenza. Dr. Steven Chavoustie served as the Principal Investigator for the study at Segal Trials. 'We are honored to have been part of a study that marks a potential paradigm shift in how we approach flu prevention,' said Dr. Steven Chavoustie, Principal Investigator at Segal Trials. The NAVIGATE trial enrolled over 5,000 healthy, unvaccinated adults and met both its primary and secondary efficacy endpoints, showing that single doses of CD388 conferred 76%, 61%, and 58% protection, respectively, across three dosage levels. Participants were monitored for symptomatic, laboratory-confirmed influenza over a 24-week period. CD388 was well-tolerated at all doses with no unexpected safety signals reported. 'We are honored to have been part of a study that marks a potential paradigm shift in how we approach flu prevention,' said Dr. Steven Chavoustie, Principal Investigator at Segal Trials. 'A once-per-season antiviral could significantly improve access to flu protection, especially among individuals for whom vaccines may not be effective.' Unlike vaccines, CD388 does not rely on the body's immune response, making it a promising option for those with compromised immunity or heightened risk for severe flu. This innovative approach represents a potential new standard of care for broad seasonal influenza protection. Following the trial's success, Cidara Therapeutics has submitted an End of Phase 2 meeting request to the U.S. Food and Drug Administration (FDA) to discuss the upcoming Phase 3 trial design. About Segal Trials Founded in 1998, Segal Trials is a privately held clinical research network with multiple sites across South Florida. Specializing in psychiatry, neurology, women's health, and general medicine, Segal Trials is committed to advancing medical research through high-quality Phase I–IV trials while helping sponsors meet enrollment goals.
Business Wire
24-06-2025
- Health
- Business Wire
Segal Trials Investigator Dr. Olga Lapeyra Contributes to Pivotal Migraine Study Leading to FDA Approval of Atzumi™
MIAMI--(BUSINESS WIRE)--Segal Trials, a South Florida-based clinical research network specializing in psychiatric and neurological disorders, is proud to recognize the contributions of Dr. Olga Lapeyra to the successful Satsuma Pharmaceuticals Phase 3 clinical trial evaluating Atzumi™ (dihydroergotamine nasal powder), recently approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine with or without aura in adults. Millions of Americans suffer from the disabling effects of migraine,' said Dr. Olga Lapeyra. 'This approval represents a major advancement in offering patients a fast, convenient, and well-tolerated option, particularly for those who haven't found relief." Share As a principal investigator at Segal Trials, Dr. Lapeyra played an important role in the Atzumi trial, overseeing recruitment, subject care, and clinical integrity throughout the studies. Her efforts led to the successful randomization of 43 subjects and helped support the trial's momentum and data quality. 'Millions of Americans suffer from the disabling effects of migraine,' said Dr. Olga Lapeyra. 'This approval represents a major advancement in offering patients a fast, convenient, and well-tolerated option, particularly for those who haven't found relief through conventional treatments. I'm proud to have contributed to this meaningful work.' Migraine remains one of the most prevalent and burdensome neurological conditions, affecting an estimated 40 million people in the U.S. and ranking among the top causes of disability worldwide. Atzumi offers patients a non-injectable formulation of dihydroergotamine (DHE), a longstanding and effective migraine treatment, now delivered via a novel, easy-to-use nasal powder. About Segal Trials Founded in 1998, Segal Trials is a privately held clinical research network with sites throughout South Florida. Specializing in psychiatry, neurology, and women's health, Segal Trials is committed to high-quality phase I-III clinical trials and reaching sponsor enrollment goals. Atzumi - IMPORTANT SAFETY INFORMATION:
Yahoo
24-06-2025
- Health
- Yahoo
Segal Trials Investigator Dr. Olga Lapeyra Contributes to Pivotal Migraine Study Leading to FDA Approval of Atzumi™
MIAMI, June 24, 2025--(BUSINESS WIRE)--Segal Trials, a South Florida-based clinical research network specializing in psychiatric and neurological disorders, is proud to recognize the contributions of Dr. Olga Lapeyra to the successful Satsuma Pharmaceuticals Phase 3 clinical trial evaluating Atzumi™ (dihydroergotamine nasal powder), recently approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine with or without aura in adults. As a principal investigator at Segal Trials, Dr. Lapeyra played an important role in the Atzumi trial, overseeing recruitment, subject care, and clinical integrity throughout the studies. Her efforts led to the successful randomization of 43 subjects and helped support the trial's momentum and data quality. "Millions of Americans suffer from the disabling effects of migraine," said Dr. Olga Lapeyra. "This approval represents a major advancement in offering patients a fast, convenient, and well-tolerated option, particularly for those who haven't found relief through conventional treatments. I'm proud to have contributed to this meaningful work." Migraine remains one of the most prevalent and burdensome neurological conditions, affecting an estimated 40 million people in the U.S. and ranking among the top causes of disability worldwide. Atzumi offers patients a non-injectable formulation of dihydroergotamine (DHE), a longstanding and effective migraine treatment, now delivered via a novel, easy-to-use nasal powder. About Segal Trials Founded in 1998, Segal Trials is a privately held clinical research network with sites throughout South Florida. Specializing in psychiatry, neurology, and women's health, Segal Trials is committed to high-quality phase I-III clinical trials and reaching sponsor enrollment goals. Atzumi - IMPORTANT SAFETY INFORMATION: View source version on Contacts For Media InquiriesSegal TrialsEmail: marketing@ Website: Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
