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# Release Details

## [COMPANY] Announces Positive Topline Results from the Pivotal Phase 3 MAESTRO-NASH Clinical Trial of [DRUG] for the Treatment of NASH and Liver Fibrosis

[DATE]

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_In MAESTRO-NASH, a 52-week serial liver biopsy Phase 3 study in more than 950 patients, [DRUG] achieved both primary endpoints and potentially clinically meaningful effects with both daily oral doses, 80 mg and 100 mg, relative to placebo_
_NASH resolution (ballooning of 0, inflammation of 0-1) and ≥2-point NAS reduction with no worsening of fibrosis (p<0.0001 at both doses)_
_Fibrosis improvement by at least one stage with no worsening of NAS (p=0.0002 and <0.0001 at 80 and 100 mg, respectively)_
_Potentially clinically meaningful LDL-lowering, a key secondary endpoint (p<0.0001)_
_Multiple positive effects on NASH biomarkers and imaging_
_[DRUG] was safe and well-tolerated in the MAESTRO-NASH study, consistent with the overall safety in Phase 3 MAESTRO trials, expanding the large safety database_
_[COMPANY] intends to file a new drug application seeking accelerated approval of [DRUG] for the treatment of non-cirrhotic NASH with liver fibrosis_

_[COMPANY] to host conference call at 8:00 am ET to review the results_

CONSHOHOCKEN, Pa., [DATE] -- [COMPANY] ([TICKER]), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced positive topline results from the pivotal Phase 3 MAESTRO-NASH biopsy clinical trial of [DRUG], a liver-directed selective thyroid hormone receptor agonist. MAESTRO-NASH, a registrational Phase 3 trial, has achieved both liver histological improvement endpoints that FDA proposed as reasonably likely to predict clinical benefit to support accelerated approval for the treatment NASH with liver fibrosis.

[EXECUTIVE], M.D., Chief Medical Officer and President of Research & Development of [COMPANY], stated, "These pivotal Phase 3 results demonstrate the potential for [DRUG] to help patients achieve improvement in both the underlying steatohepatitis that drives this disease and the resulting fibrosis that is associated with progression to cirrhosis and its complications. The topline data also reinforce our confidence in the safety and tolerability profile of [DRUG]. We believe the Phase 3 MAESTRO clinical development program, including the MAESTRO-NAFLD-1 and MAESTRO-NAFLD-OLE safety clinical trials and the recently initiated MAESTRO-NASH-OUTCOMES clinical trial, provides a strong foundation for our new drug application (NDA) and the potential accelerated approval of [DRUG] for the treatment of non-cirrhotic NASH with liver fibrosis."

[EXECUTIVE] added, "I want to thank the MAESTRO-NASH investigators and study sites participating in the study, my colleagues on the R&D team at [COMPANY], and, most of all, the patients who made achievement of this important milestone possible."

[EXECUTIVE], M.D., Chairman for both [COMPANY] and [COMPANY], San Antonio, Texas, Visiting Professor of Hepatology, Oxford University, and lead Principal Investigator of the MAESTRO studies, commented, "NASH with liver fibrosis puts patients at risk of progressing to liver failure, liver cancer, need for liver transplant, and premature mortality; with no approved treatment, this disease represents one of the most urgent unmet needs in healthcare today. These unprecedented results from the MAESTRO-NASH clinical trial signal a major turning point for the field."

[EXECUTIVE], M.D., Chief Executive Officer of [COMPANY], stated, "MAESTRO-NASH achieved both primary endpoints proposed by the FDA as reasonably likely to predict clinical benefit and we have established a large safety database, supported by a second Phase 3 clinical trial (MAESTRO-NAFLD-1) and MAESTRO-NAFLD-OLE, to inform benefit-risk assessment. With these unequivocally positive Phase 3 data in hand, our path forward is clear. In the first half of 2023, we intend to file a new drug application seeking accelerated approval of [DRUG]. I want to thank my colleagues for their sustained efforts and strong execution; our team is committed to delivering [DRUG] to patients in need."

**MAESTRO-NASH Week 52 Results**

MAESTRO-NASH is an ongoing blinded Phase 3 clinical trial, and enrolled patients continue on therapy after the Week 52 liver biopsy for up to a total of 54 months to accrue hepatic clinical outcome events including histologic conversion to cirrhosis and hepatic decompensation events.

**Efficacy Results**

Patients meeting eligibility requirements for MAESTRO-NASH were randomized 1:1:1 to receive [DRUG] 80 mg, [DRUG] 100 mg, or place