Pharmazz Inc. Announces Enrollment of First Patient in Phase 3 Clinical Trial of Sovateltide for Treating Patients with Cerebral Ischemic Stroke

Associated Press

4 days ago

The Phase 3 clinical trial of sovateltide, RESPECT-ETB, is expected to enroll over 500 patients with a primary endpoint of proportion of patients demonstrating functional independence at 90 days and is being conducted under a Special Protocol Assessment (SPA) with the FDA.
Sovateltide, a potential first-in-class, highly selective endothelin-B (ETB) receptor agonist, has previously demonstrated significant improvement in stroke patients compared to standard of care in a Phase 3 trial that served as the basis for regulatory approval in India.
Recent $25 million equity investment from Sun Pharmaceutical Industries Limited, provides sufficient capital to complete the Phase 3 trial.
WILLOWBROOK, Ill., July 29, 2025 (GLOBE NEWSWIRE) -- Pharmazz, Inc. ('Pharmazz' or the 'Company'), a late-stage biopharmaceutical company developing innovative therapies for unmet medical needs in critical care and neurology, today announced that the first patient has been enrolled and treated in the pivotal Phase 3 RESPECT-ETB clinical trial assessing the safety and efficacy of sovateltide for the treatment of acute cerebral ischemic stroke ( NCT05691244 ). Sovateltide represents a potential breakthrough as a first-in-class endothelin-B receptor agonist, uniquely promoting neurovascular remodeling—generating new neurons (neurogenesis), blood vessels (angiogenesis), and enhancing mitochondrial function.
'There has not been a new FDA approved non-thrombolytic therapy for stroke in over 30 years. We have already shown promising results in our previous Phase 3 study, which showed that sovateltide could be a meaningful advance over standard of care to promote a fast recovery and improve neurological outcomes in cerebral ischemic stroke patients,' said Emeritus Prof. Anil Gulati, CEO and Founder of Pharmazz. 'We have now treated the first patient in our US-based Phase 3 clinical trial and have sufficient capital to complete this study to further cement the potential for sovateltide to transform the treatment of cerebral ischemic stroke.'
'There is a massive and ongoing medical burden associated with ischemic stroke, which continues to be a leading cause of long-term disability, affecting hundreds of thousands of patients each year,' said Dr. Thomas Devlin, MD, PhD, FSVIN, physician executive of Neurosciences and medical director at CHI Memorial Stroke and Neuroscience Center, and principal investigator of the Phase 3 trial. 'Current treatment options remain limited, underscoring the critical need for novel therapies. Given the promising results already demonstrated with sovateltide, this rigorous Phase 3 study represents an important step toward addressing this urgent unmet medical need.'
Phase 3 Trial of Sovateltide for Stroke Covered by Special Protocol Assessment
Sovateltide is a first-in-class endothelin-B receptor (ETBR) agonist to treat acute cerebral ischemic stroke that can be administered up to 24 hours after the onset of symptoms. Pharmazz has received agreement from the US Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the study design and statistical analysis plan of its Phase 3 clinical trial of sovateltide for the treatment of acute cerebral ischemic stroke patients.
Pharmazz has now enrolled and treated the first patient in its Phase 3 trial, RESPECT-ETB (ClinicalTrials.gov ID: NCT05691244 ). The Phase 3 clinical trial is designed to enroll a total of 514 stroke patients at 65 sites in the US, Germany, Spain, and the UK. The primary endpoint is the proportion of patients demonstrating functional independence post-stroke, defined as a modified Rankin Scale (mRS) score of 0–2 at 90 days after stroke onset.
About Sovateltide and Stroke
Stroke is a leading cause of long-term disability in the United States, affecting more than 795,000 people each year, and reduces mobility in more than half of stroke survivors over the age of 651. Sovateltide is a first-in-class drug to treat acute cerebral ischemic stroke, a condition in which the loss of blood supply to the brain prevents brain tissue from receiving oxygen and nutrients, resulting in potential brain damage, neurological deficits, or death. Sovateltide is unique because its action site is the neural progenitor cells. Sovateltide promotes neurovascular remodeling by inducing the formation of new neurons (neurogenesis) and blood vessels (angiogenesis). Sovateltide also protects neural mitochondria and enhances their biogenesis. The Phase 3 trial that served as the basis for approval in India was published in 2024 and showed that the sovateltide group (n=80) had a significantly greater number of cerebral ischemic stroke patients with lower mRS and NIHSS scores at 90 days post-treatment than the control group (n=78).2
About Pharmazz, Inc.
Pharmazz is a privately held company developing novel products in critical care medicine. Pharmazz, Inc. has obtained marketing authorization for two of its first-in-class drug molecules, centhaquine and sovateltide, for the treatment of hypovolemic shock and ischemic stroke, respectively, in India. In addition, the US Food and Drug Administration (FDA) has approved two phase III INDs for centhaquine as an agent for hypovolemic shock and sovateltide for cerebral ischemic stroke. Additional information may be found on the Company's website, www.pharmazz.com.
Disclaimer:
Statements in this 'Document' describing the Company's objectives, projections, estimates, expectations, plans or predictions, or industry conditions or events may be 'forward-looking statements' within the meaning of applicable securities laws and regulations. Actual results, performance, or achievements could differ materially from those expressed or implied. The Company undertakes no obligation to update or revise forward-looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof.
Contacts:
1 Centers for Disease Control. https://www.cdc.gov/stroke/data-research/facts-stats/index.html
2 Drugs. 2024 Nov 15;84(12):1637–1650. doi: 10.1007/s40265-024-02121-5