Tesamorelin · research summary

Non-Alcoholic Steatohepatitis (NASH) - A Review of a Crowded Clinical Landscape, Driven by a Complex Disease.

Drug design, development and therapy · 2021. Summary drawn from the study's full text. Each statement is followed by the exact sentence it comes from. This is a research summary, not medical advice.

Study type

Review of the therapeutic landscape for non-alcoholic steatohepatitis (NASH), comparing drug classes and clinical trial outcomes.
“Here, we have performed an exhaustive review of the current therapeutic landscape for this disease and compared, in some detail, the fortunes of different drug classes (biologics vs small molecules) and target molecules.”

Subjects

Patients with non-alcoholic steatohepatitis (NASH) and non-alcoholic fatty liver disease (NAFLD), including those with various stages of liver fibrosis.
“Non-alcoholic steatohepatitis (NASH) is a progressive form of non-alcoholic fatty liver disease (NAFLD), characterized by chronic inflammation and accumulation of fat in liver tissue.”

Reported findings

No FDA-approved therapies specifically for NASH existed at the time of writing, despite several candidates in late-stage development.
“At the time of writing this review, only Zydus Cadila’s new drug application for Saroglitazar had been approved (2020) for NASH therapy in India.”
Several drug candidates in Phase 3 trials, such as Obeticholic acid and Cenicriviroc, faced setbacks including FDA rejection or trial termination due to lack of efficacy or safety concerns.
“However, at the beginning of 2021 the AURORA phase 3 clinical trial terminated due to lack of efficacy on the results of the first part of the study.”
The complex pathophysiology of NASH suggests that single therapies are unlikely to be sufficient, and combination therapies with different mechanisms of action may be required.
“Hence, the development of a single therapy for NASH seems challenging and unlikely, despite the plethora of later stage trials due to report.”

Limitations stated by the authors

The review notes that liver biopsy remains the gold standard for diagnosis, which is invasive and limits broad testing and earlier diagnosis.
“Regulators have also highlighted the need to identify less-invasive biomarkers to supplant liver biopsy as the gold standard for diagnosis and assessment of the disease, enabling much broader testing and earlier diagnosis, as well as accelerated drug development outcomes.”

Source: PubMed 34588764 · DOI 10.2147/DDDT.S315724 · all study summaries

Study type

Review of the therapeutic landscape for non-alcoholic steatohepatitis (NASH), comparing drug classes and clinical trial outcomes.

“Here, we have performed an exhaustive review of the current therapeutic landscape for this disease and compared, in some detail, the fortunes of different drug classes (biologics vs small molecules) and target molecules.”

Subjects

Patients with non-alcoholic steatohepatitis (NASH) and non-alcoholic fatty liver disease (NAFLD), including those with various stages of liver fibrosis.

“Non-alcoholic steatohepatitis (NASH) is a progressive form of non-alcoholic fatty liver disease (NAFLD), characterized by chronic inflammation and accumulation of fat in liver tissue.”

Reported findings

No FDA-approved therapies specifically for NASH existed at the time of writing, despite several candidates in late-stage development.

“At the time of writing this review, only Zydus Cadila’s new drug application for Saroglitazar had been approved (2020) for NASH therapy in India.”

Several drug candidates in Phase 3 trials, such as Obeticholic acid and Cenicriviroc, faced setbacks including FDA rejection or trial termination due to lack of efficacy or safety concerns.

“However, at the beginning of 2021 the AURORA phase 3 clinical trial terminated due to lack of efficacy on the results of the first part of the study.”

The complex pathophysiology of NASH suggests that single therapies are unlikely to be sufficient, and combination therapies with different mechanisms of action may be required.

“Hence, the development of a single therapy for NASH seems challenging and unlikely, despite the plethora of later stage trials due to report.”

Limitations stated by the authors

The review notes that liver biopsy remains the gold standard for diagnosis, which is invasive and limits broad testing and earlier diagnosis.

“Regulators have also highlighted the need to identify less-invasive biomarkers to supplant liver biopsy as the gold standard for diagnosis and assessment of the disease, enabling much broader testing and earlier diagnosis, as well as accelerated drug development outcomes.”