Acella Pharmaceuticals and Neuvosyn Laboratories have announced positive topline results from a phase 2 clinical trial of North Star, an investigational desiccated thyroid extract (DTE) for hypothyroidism.
The study met its primary endpoint, successfully defining the dose conversion ratio between levothyroxine and North Star.
The trial also demonstrated a favourable safety profile. Conducted under the investigational name North Star, the study was led by Acella through its sister company Neuvosyn Laboratories, which develops regulatory applications for the firm.
Art Deas, Chief Executive Officer of Acella Pharmaceuticals, said: “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.”
Hypothyroidism is a chronic condition caused by insufficient production of thyroid hormones. These hormones regulate metabolism, energy, heart function and brain health. Symptoms include fatigue, weight gain, depression and cognitive difficulties.
Francesco S Celi MD, MHSc, chair of the Department of Medicine at UConn School of Medicine and UConn Health, said: “These positive results add to the significant body of evidence highlighting why DTE products have been utilised for over a century to reliably treat hypothyroidism.”
He added: “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.”
Acella is the maker of NP Thyroid, the most prescribed DTE in the US. Around 1.5 million Americans rely on DTEs like NP Thyroid. The company says it remains committed to advancing treatment options and supporting patient choice through domestic manufacturing and scientific innovation
