Acella Pharmaceuticals and Neuvosyn Laboratories have reported positive topline results from a Phase 2 randomized, double-blind controlled clinical trial of North Star, an investigational desiccated thyroid extract (DTE) for the treatment of hypothyroidism. The study met its primary endpoint, successfully defining the dose conversion ratio from levothyroxine (LT4) to North Star, and demonstrated a favourable safety profile.

Hypothyroidism is a chronic condition in which the thyroid gland does not produce sufficient hormones, affecting metabolism, energy production, heart function, and cognitive processes. Patients with hormone deficiencies may experience fatigue, weight gain, depression, cold sensitivity, and cognitive difficulties.

“These successful results highlight a critical step forward in the FDA approval process of desiccated thyroid extract. We look forward to continuing to work with the FDA to gain Biologics License Application approval of North Star,” Art Deas, chief executive officer of Acella Pharmaceuticals, said.

North Star provides both T4 (thyroxine) and T3 (triiodothyronine), reflecting the composition of other DTE products used in clinical practice. “These positive results add to the significant body of evidence highlighting why DTE products have been utilized for over a century to reliably treat hypothyroidism,” Francesco S. Celi, MD, MHSc, chair of the Department of Medicine at UConn School of Medicine and UConn Health, said. “DTEs provide both T4 and T3, a combination that has been shown in some studies to provide symptom relief to patients who do not feel fully restored on other treatments.”

The trial was conducted under the investigational name North Star through Neuvosyn Laboratories, which supports Acella Pharmaceuticals in developing New Drug Applications and Biologics License Applications.

Acella and Neuvosyn Laboratories aim to advance treatment options for hypothyroidism and provide additional therapies for patients who may not achieve full symptom relief on standard levothyroxine therapy.