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Kriya Acquires Tramontane Therapeutics and Launches Gene Therapy Program for Nonalcoholic Steatohepatitis (NASH) and Other Prevalent Diseases

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September 11, 2023

Kriya Therapeutics has acquired Tramontane Therapeutics, gaining access to a portfolio of gene therapy assets focused on Fibroblast Growth Factor 21 (FGF21) for metabolic and neurodegenerative diseases. This acquisition enhances Kriya’s metabolic disease portfolio, with a lead FGF21 program for treating non-alcoholic steatohepatitis (NASH), a condition with limited treatment options. Kriya aims to develop a one-time intramuscular AAV gene therapy for NASH treatment, which could offer benefits such as improved compliance, native FGF21 expression, steady protein levels, and long-term efficacy.

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.

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“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.”

Source: BioSpace

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