Pharmazz, Inc. a late-stage biopharmaceutical company developing innovative therapies for unmet medical needs in critical care and neurology, has announced a 25 million USD equity investment from Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, "Sun Pharma" and includes its subsidiaries and/or associate companies), one of the world’s leading pharmaceutical companies. This strategic investment brings Sun Pharma’s total commitment in Pharmazz to 40 million USD (including a previous 15 million USD equity investment).
“We believe sovateltide has the potential to redefine the treatment of ischemic stroke, which has not seen a new FDA approved non-thrombolytic therapy in over 30 years. This investment means we are now fully funded to complete our pivotal Phase 3 study and execute on our mission to make this first in class therapy available to stroke patients,” said Emeritus Prof. Anil Gulati, CEO and Founder of Pharmazz. “We deeply value Sun Pharma’s continued partnership, which strengthens our ability to bring our therapies to patients worldwide.”
The new funding will provide Pharmazz with the capital required to complete the pivotal U.S. Phase 3 clinical trial of sovateltide (known as Tycamzzi® and Tyvalzi™ in international markets), its lead drug candidate for treating acute cerebral ischemic stroke.
Dr. Neil Marwah, President of Pharmazz, added, “This investment gives us the operational runway to execute a complex, multi-country clinical trial and scale the company responsibly as we prepare for a potential public offering. We are thrilled to strengthen our partnership with Sun Pharma, whose continued support reflects deep confidence in our platform and our ability to execute.”
Phase 3 Trial of Sovateltide for Stroke Covered by Special Protocol Assessment
Sovateltide is a first-in-class endothelin-B receptor 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 is initiating the Phase 3 RESPECT-ETB (ClinicalTrials.gov ID: NCT05691244) trial at 65 sites in the US, Germany, Spain, and the UK, designed to enroll 514 stroke patients. 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.
Commercially Approved in India: Early Validation from 60,000+ patients
Sovateltide was approved in 2023 in India and marketed by Sun Pharma under the brand name Tyvalzi™, offering compelling proof of concept for global commercialization. In a randomized, placebo-controlled, multicenter clinical trial conducted in 158 cerebral ischemic stroke patients conducted in India, the product was shown to be well tolerated and effective in improving neurological outcomes when administered within 24 hours of stroke symptoms.
• Patients on Sovateltide were 22.7% more likely to achieve functional independence at 90 days (as measured by mRS score 0–2; p=0.0045)
• Sovateltide delivered a 17.1% higher rate of favorable National Institutes of Health Stroke Scale (NIHSS) scores (p=0.0024)
• The ordinal shift in mRS and NIHSS score between control and sovateltide groups was favorable towards sovateltide across the entire range.
• Results represent the first statistically significant clinical data in stroke in 30 years, since the introduction of alteplase (tPA)
• Over 60,000 patients treated to date since commercial launch in India
