Arrowhead drug shows strong efficacy in cutting blood fat

Arrowhead Pharmaceuticals Inc. ARWR stock is trading higher on Wednesday as the company revealed successful topline outcomes from its late-stage SHASTA-3 and SHASTA-4 trials evaluating plozasiran in individuals suffering from severe hypertriglyceridemia.

Hypertriglyceridemia is the presence of high levels of triglycerides (a type of fat) in the blood. The disease substantially raises the likelihood of fatal acute pancreatitis and frequent hospitalizations.

Trial Outcomes And Efficacy Highlights

Both Phase 3 investigations successfully achieved their primary milestone by cutting triglyceride levels compared to a placebo.

Additionally, the studies satisfied all secondary objectives, demonstrating a statistically meaningful drop in acute pancreatitis occurrences.

Patients receiving a quarterly 25 mg subcutaneous dose of plozasiran experienced median triglyceride decreases of 79% in SHASTA-3 and 81% in SHASTA-4 after 12 months, whereas placebo groups saw reductions of around 27%.

A combined analysis indicated a statistically significant drop in single-event patient rates (p<0.0221) and overall event frequency (p<0.0077).

Across the broader patient group with triglyceride counts exceeding 500 mg/dL, cumulative pancreatitis events fell by 78%.

Notably, high-risk patients possessing triglyceride levels above 880 mg/dL alongside a history of acute pancreatitis achieved a 100% reduction in pancreatitis incidents compared to placebo.

Safety Metrics And Regulatory Roadmap

Plozasiran exhibited a favorable safety profile, showing treatment-related adverse events in line with earlier trial observations.

Researchers recorded no novel safety concerns, standard laboratory variations, hypersensitivity cases, or thrombocytopenia risks. Liver enzyme changes remained clinically insignificant, and liver fat content evaluations matched placebo levels.

While complete evaluation of the trials continues ahead of future publications, plozasiran currently holds regulatory clearance under the brand name Redemplo across several regions, including the U.S., European Union, China, Australia, and Canada, for familial chylomicronemia syndrome.

The company plans to use data from SHASTA-3, SHASTA-4, and MUIR-3 to submit a supplemental new drug application to the U.S. FDA before the end of 2026, alongside seeking global authorizations.

ARWR Stock Price Activity: Arrowhead shares were up 22% at $90.96 at last check on Wednesday, according to Benzinga Pro data.

Photo by T. Schneider via Shutterstock

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This article Arrowhead Drug Shows Strong Efficacy In Cutting Blood Fat originally appeared on Benzinga.com.