Back– Kriya envisions treating people with NASH using a one-time intramuscular gene therapy enabling continuous expression of native FGF21 –
– Kriya anticipates advancing its NASH gene therapy candidate into the clinic by 1H 2025 –
PALO ALTO, Calif. and RESEARCH TRIANGLE PARK, NC — Sept. 6, 2023 — Kriya Therapeutics, Inc., (“Kriya”) a biopharmaceutical company developing gene therapies for conditions affecting millions of people around the world, today announced that it has acquired Tramontane Therapeutics, Inc. (“Tramontane”). Tramontane is a private gene therapy company focused on developing treatments for metabolic and neurodegenerative diseases. Tramontane, a spin out from Universitat Autònoma de Barcelona (UAB), is now a wholly owned subsidiary of Kriya.
With the transaction, Kriya acquires a portfolio of Fibroblast Growth Factor 21 (FGF21) assets including Tramontane’s lead program, an adeno-associated virus (AAV) vector designed to express a steady level of the native FGF21 protein. FGF21 has beneficial metabolic effects across several target organs including the liver. Importantly, FGF21 has been established as a clinically-validated biological target in NASH, which Kriya has prioritized as its lead FGF21 program.
Both companies believe that a one-time intramuscular AAV gene therapy designed to express native FGF21 protein is a novel approach to treating NASH with significant potential for a better efficacy, safety, tolerability and pharmacokinetic profile than other products in development.
“We are very impressed with the data associated with the Tramontane FGF21 program, which has consistently established strong efficacy and durability across multiple validated animal models of obesity and NASH,” said Shankar Ramaswamy, M.D., Co-Founder and CEO of Kriya. “The addition of Tramontane’s FGF21 program strategically aligns with our Metabolic Disease portfolio which also includes a one-time gene therapy candidate for insulin-dependent diabetes.”
Kriya’s gene therapy candidate for treating people with NASH may have the following benefits:
- One-time intramuscular AAV administration may eliminate compliance issues associated with complex medication regimens;
- Native FGF21 avoids unnatural modifications incorporated into FGF21 analogs to extend half-life, which may support better tissue distribution and receptor binding;
- Continuous expression of FGF21 delivers a steady level of the protein, to avoid peak-to-trough pharmacokinetic variability associated with repeatedly-injected recombinant analog products, which may lead to better treatment outcomes; and
- Longterm durable action of FGF21 through gene therapy has the potential to deliver multiyear efficacy in the setting of a chronic lifelong disease.
“People with NASH are in desperate need of better treatment options and FGF21 is a clinically-validated target for preventing fibrosis in this disease,” said Fátima Bosch, Ph.D., Professor in Biochemistry and Molecular Biology at UAB, Co-Founder, President and Chief Scientific Advisor of Tramontane Therapeutics, and Kriya Scientific Advisory Board Member. “With the ongoing research that continues in this disease, including innovative approaches like gene therapy, the future outlook for NASH treatments has markedly improved. I believe that a one-time gene therapy would be a quantum leap forward in the management of this chronic disease.”
About Nonalcoholic Steatohepatitis (NASH)
NASH is the most severe form of nonalcoholic fatty liver disease (NAFLD) and affects approximately 17 million people in the United States. It is a condition in which the liver builds up excessive fat deposits causing inflammation and liver cell damage. NASH can progress to more serious disease stages, such as fibrosis, cirrhosis, liver failure or liver cancer. Approximately 20 percent of people with NASH will progress to advanced liver disease including cirrhosis and cancer over several years or decades; in advanced stages of the disease, liver transplant may be the only option. There are currently no FDA-approved therapies for halting or reversing the progression of NASH.
About Kriya Therapeutics
Our mission is to revolutionize medicine, with the ultimate goal of eliminating human suffering and enabling people to live without the burden of disease. Kriya is a biopharmaceutical company developing gene therapies to address diseases affecting millions of people around the world. With operations in Palo Alto, California and Research Triangle Park, North Carolina, Kriya has raised over $600 million in committed capital, which will be used to advance a broad pipeline of gene therapies for ophthalmology, neurology and metabolic disease. For more information, please visit www.kriyatx.com and follow us on LinkedIn and Twitter.
About Tramontane Therapeutics
Tramontane Therapeutics is a gene therapy company focused on developing treatments for prevalent neurodegenerative and metabolic diseases. Tramontaneuses adeno-associated viral vectors to express therapeutic proteins of relevance in the management of multiple diseases, including Non-alcoholic steatohepatitis (NASH), Type 2 diabetes, Obesity, Alzheimer’s disease, Parkinson disease and other central disorders associated with impaired cognition and behavior.
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