In a significant development, a Hyderabad-based startup has raised hopes of relief for acute liver disease patients.
Tulsi Therapeutics has developed Tulsi-28X, a therapeutic product that has reversed liver fibrosis in animal trials.
The startup incubated at the ASPIRE-BioNEST at the University of Hyderabad (UoH) claimed that it is the world’s first successful animal trial of a novel stem cell–exosome combination therapy for chronic liver failure.
The regenerative therapy is derived from Wharton’s Jelly mesenchymal stem cells and their native exosomes—a combination never before tested in any animal model worldwide.
Biotech industry
The Hyderabad Company fully developed the platform during three years of research at ASPIRE-BioNEST. The preclinical trial, conducted in collaboration with global experts including Dr. Naga Chalasani (Indiana University, USA) and Dr. Ajay Duseja (PGIMER, Chandigarh), demonstrated 100% of the animals treated with Tulsi-28x showed reversal of liver fibrosis (indicating liver regeneration) resulting in zero deaths, compared to only 14% reversal (p<0.001) and 43% deaths (p<0.0066) in the untreated control group.
“This is a significant milestone for India’s biotech industry,” said Dr. Sairam Atluri, Founder & CEO of Tulsi Therapeutics.
ASPIRE-BioNEST provided a world-class platform that helped the research-driven startup to translate its vision into scientific reality. While human trials are the next challenge, this study opens doors to a new class of biologics in liver disease, Dr Sairam explained.
Regenerative medicine
The results were initially presented at the AASLD 2024 Liver Conference in San Diego, US. Recently, the work has been accepted for publication in the Journal of Regenerative Medicine.
Tulsi Therapeutics claimed it is the world’s first biotech company developing a dual stem cell–exosome biologic. Tulsi-28X works by secreting regenerative proteins and growth factors, stimulating the repair of diseased liver tissue.
Collaboration with NIMS
“We are committed to developing world-class yet affordable regenerative solutions,” said Dr. Ravi Bonthala, Chief Scientific Officer, Tulsi Therapeutics. “Our next step is to take Tulsi-28X into human clinical trials in collaboration with Nizam’s Institute of Medical Sciences (NIMS), Hyderabad.
Chronic liver failure is a serious public health concern in India, contributing to nearly 20% of global liver-related deaths. The numbers are also growing with lifestyle changes. Liver transplantation is the only current treatment, which is both expensive and also not easy due to the medical challenge and the availability of organs for transplant. In this background, Tulsi-28X represents a significant development in the interest of the patients.
Using stem cells and exosomes
Tulsi Therapeutics is focused on regenerative medicine using stem cells and exosomes. It is part of the BIRAC-supported incubator network and aims to develop accessible biologics for diseases with limited treatment options.
ASPIRE-BioNEST is supported by the Department of Biotechnology (DBT). According to its CEO, Dr Anil Kondareddy, with 23,000 plus sq ft of lab infrastructure, it supports early-stage biotech startups through mentoring, infrastructure, and access to funding. In the last seven years, BioNEST has supported 75 life sciences startups
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