DURECT’s lead asset, Larsucosterol, is an epigenetic modulator with FDA Breakthrough Therapy Designation
Bausch Health Companies Inc., a global, diversified pharmaceutical company, and DURECT Corporation announced a definitive agreement under which Bausch Health will indirectly acquire DURECT Corporation, including a novel therapeutic molecule, larsucosterol, which can harness the power of epigenetic modulation. Larsucosterol, an endogenous sulfated oxysterol and an epigenetic modulator, has demonstrated promising results for the treatment of alcoholic hepatitis (AH) in Phase 2 trials. Bausch Health’s hepatology development and commercial capabilities are well-suited to support the clinical development and potential commercialization of larsucosterol.
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AH is a life-threatening form of alcohol-associated liver disease (ALD), which can occur in individuals who chronically misuse alcohol. It is characterized by severe inflammation and destruction of liver tissue (i.e., necrosis). AH accounted for roughly 164,000 hospital admissions in the U.S. in 2021. There is currently no Food and Drug Administration (FDA) or European Medicines Agency (EMA) approved treatment for AH, and novel therapeutic strategies are needed to improve patient survival.
“This announcement is fundamental progress on our Strategic Priority – Innovation, which is to intensify focus and operating rigor behind R&D and business development and demonstrates our commitment to hepatology and finding new ways to address unmet medical needs, living our purpose of enriching lives through our relentless drive to deliver better health outcomes for patients.” said Thomas J. Appio, Chief Executive Officer, Bausch Health.
“There is a significant unmet need in the treatment of patients with AH given the high mortality rate and that there are no currently approved treatments. We are very excited to add larsucosterol, an asset which has FDA Breakthrough Therapy Designation, to our pipeline, particularly as it builds on our existing expertise within the hepatology space. It is complementary to our ongoing Phase 3 program of soluble solid dispersion of rifaximin (rifaximin SSD) being studied in cirrhotic patients globally,” stated Jonathan Sadeh M.D., M.Sc. as Executive Vice President, Chief Medical Officer and Head of R&D at Bausch Health.
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“AH, by our estimates, is responsible for about 100 deaths per day in the US and billions of dollars in healthcare costs,” stated James E. Brown, D.V.M., President and CEO of DURECT. “Since we reported results from our Phase 2b AHFIRM clinical trial for larsucosterol in AH, our primary focus has been advancing larsucosterol towards the completion of clinical development. We chose this transaction with Bausch Health because we believe it provides significant value for our stakeholders, both immediately and in the long term, should larsucosterol be approved and achieve commercial success. We view Bausch Health as the right partner to advance larsucosterol due to their expertise in hepatology, commercial success with Xifaxan and experienced development team. We look forward to the potential impact larsucosterol could have for patients with AH and the medical community that cares for them. Thank you to our team at DURECT and our partners that have helped advance larsucosterol to this point.”
A registrational Phase 3 program to evaluate the safety and efficacy of larsucosterol for the treatment of patients with severe AH is being planned. The trial will be a randomized, double-blind, placebo-controlled, multi-center study. The primary endpoint will be 90-day survival. The trial design will incorporate feedback received from the FDA during a Type B meeting under Breakthrough Therapy Designation as well as learnings from the prior Phase 2b AHFIRM trial in AH.
The acquisition of the clinical development program for larsucosterol in AH compliments the ongoing Bausch Health RED-C clinical program which is designed to assess the efficacy of a next generation therapeutic, rifaximin SSD, to delay onset of first overt hepatic encephalopathy (OHE) hospitalization and all-cause mortality. There are no medications globally approved for the primary prophylaxis and delay in decompensation to first episode of OHE in cirrhosis. Patient enrollment in two global Phase 3, randomized, double-blind, placebo-controlled studies is now complete with efficacy and safety results expected to be announced in early 2026.
“The addition of larsucosterol to our pipeline is a strategic fit with our focus in hepatology and underscores our continued dedication to exploring and identifying new treatments for individuals who are suffering with liver disease and its complications,” stated Aimee Lenar, Executive Vice President of US Pharma at Bausch Health. “We are excited to continue investment in bringing these breakthrough options to market, not just in the US, but also globally.”
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Source- PR Newswire
