Bluejay Therapeutics Reports First Preclinical Data for Liver-Targeted Fatty Acid Synthase (FASN) Inhibitor BJT-188 Being Investigated for the Treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH)

BJT-188 demonstrated liver-specific potency with minimal exposure to other tissues

The data are being presented at the European Association for the Study of the Liver (EASL) Congress 2025

REDWOOD CITY, Calif., May 07, 2025 (GLOBE NEWSWIRE) — Bluejay Therapeutics, a clinical-stage biopharmaceutical company dedicated to developing potentially life-changing therapeutics for serious viral and liver diseases, today announced preclinical data on BJT-188, a liver-targeted fatty acid synthase (FASN) inhibitor being investigated for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). BJT-188 demonstrated potent FASN inhibition in preclinical models, with reduced systemic exposure that may help minimize toxicities. BJT-188 is a product of Bluejay Therapeutics’ Liver-Targeting Advanced Platform (L-TAP) that integrates molecular modeling and drug design to create novel therapeutics with optimized liver-targeted distribution profiles.

The data are being presented in a poster at the European Association for the Study of the Liver (EASL) Congress 2025. The poster is also available on Bluejay’s website.

“MASH represents a serious and growing global health challenge,” said Hassan Javanbakht, Ph.D., Chief Scientific Officer of Bluejay Therapeutics. “While FASN inhibitors offer therapeutic potential, many have been limited by systemic side effects. Our preclinical data suggest that BJT-188 may potentially overcome these challenges by reducing systemic exposure while maintaining therapeutic efficacy in the liver. We are now moving the program into IND-enabling studies.”

Preclinical Characterization of BJT-188

This study evaluated the intrinsic potency of BJT-188 versus denifanstat, an investigational FASN inhibitor, by measuring in vitro inhibition of de novo lipogenesis (DNL) in primary rat, mouse and human hepatocytes. BJT-188 inhibited DNL in primary human hepatocytes with an EC₅₀ of 20.4 ± 9.9 nM and demonstrated comparable potency in rat and mouse hepatocytes.

In vivo, a single oral dose of BJT-188 in rats demonstrated rapid and preferential accumulation in the liver, with similar liver targeting observed in mice. Liver-to-plasma and liver-to-skin ratios were significantly more favorable for BJT-188 compared to denifanstat. The minimal exposure to skin and other peripheral tissues suggests a lower risk of alopecia, a side effect reported with denifanstat.

Additionally, in an in vivo rat study, BJT-188 inhibited palmitate formation in a dose-dependent manner, reaching up to 98% inhibition of DNL at the highest dose tested (60 mg/kg). Palmitate is the primary fatty acid produced during DNL.

More details are available in the poster:

• Title: Preclinical characterization of BJT-188, a liver-targeted fatty acid synthase (FASN) inhibitor for the treatment of MASH
• Abstract number: 2721
• Poster number: FRI-375
• Session: Poster – MASLD: Experimental and pathophysiology
• Date: Friday, May 9
• Time: 8:30 a.m. CET
• Presenter: Jerome Deval, Ph.D., Bluejay Therapeutics

About Metabolic Dysfunction-Associated Steatohepatitis (MASH) 
Metabolic dysfunction-associated steatohepatitis (MASH) is a severe liver disease that affects an estimated 5% of the global adult population. In the United States, it is estimated that MASH currently impacts approximately 13 million adults and is expected to impact more than 19 million by 2039. MASH is characterized by fat accumulation, inflammation and fibrosis in the liver. Increasing fibrosis is associated with a greater risk for progression to liver-related complications, including cirrhosis, liver cancer and liver-related death. MASH is also a leading cause of liver transplant. There are limited treatment options for MASH worldwide, with only one treatment currently approved in the United States.

About BJT-188 
BJT-188 is a preclinical, liver-targeted fatty acid synthase (FASN) inhibitor currently under investigation by Bluejay Therapeutics for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). BJT-188 targets the FASN enzyme, which is involved in converting dietary sugar metabolites into lipotoxic lipids. Preclinical data on BJT-188 showed potent FASN inhibition with high liver tissue distribution specificity. BJT-188 was developed utilizing Bluejay Therapeutics’ proprietary Liver-Targeting Advanced Platform (L-TAP) to enhance its liver-specific delivery. The program is currently advancing toward IND-enabling studies.

About Liver-Targeting Advanced Platform (L-TAP)
Bluejay Therapeutics’ Liver-Targeting Advanced Platform (L-TAP) integrates molecular modeling and drug design to create novel therapeutics with optimized liver targeting. By enhancing liver specificity, L-TAP aims to reduce drug distribution to peripheral tissues, thereby improving therapeutic efficacy and minimizing side effects. L-TAP has been applied to the development of BJT-628, a hepatitis B virus (HBV) transcript inhibitor currently under evaluation as part of potential combination regimens aimed at achieving a functional cure for chronic hepatitis B (CHB), and BJT-188, a fatty acid synthase (FASN) inhibitor being investigated for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). Both BJT-628 and BJT-188 have demonstrated promising results in preclinical studies.

About Bluejay Therapeutics  
Bluejay Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing potentially life-changing therapeutics for serious viral and liver diseases. The company is currently investigating brelovitug for the treatment of chronic hepatitis D (CHD) and chronic hepatitis B (CHB) viral infections. Additionally, Bluejay is advancing several innovative programs with the goal of developing a combination regimen to achieve a functional cure for chronic hepatitis B, including a proprietary TLR9 agonist (cavrotolimod) and a liver-targeted HBV transcript inhibitor (BJT-628). The company is also investigating BJT-188, a preclinical liver-targeted fatty acid synthase (FASN) inhibitor, for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). For more information on Bluejay Therapeutics, please visit the company’s website at www.bluejaytx.com or follow the company on LinkedIn. 

Media Contact: 
Dan Boyle 
Orangefiery 
[email protected]
818-209-1692 

Investor Contact:
Peter Garcia
CFO, Bluejay Therapeutics
[email protected]
650-674-2480

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