Acella Pharmaceuticals and Neuvosyn Laboratories Report Positive Phase 2 Results
Acella Pharmaceuticals, in collaboration with its sister company Neuvosyn Laboratories, has announced encouraging topline results from a phase 2 clinical trial of North Star, an investigational desiccated thyroid extract (DTE) therapy for hypothyroidism.
The study marks an important milestone in the development of the treatment, bringing it one step closer to potential FDA approval.
Trial Success and Safety Profile
The phase 2 study met its primary endpoint, establishing the dose conversion ratio between levothyroxine – the standard synthetic treatment for hypothyroidism – and North Star. In addition to this achievement, the therapy demonstrated a favourable safety profile, reinforcing its potential as a safe and effective treatment option.
Conducted under the investigational name North Star, the study was led by Acella Pharmaceuticals through Neuvosyn Laboratories, which develops regulatory applications for the firm.
A Step Towards FDA Approval
The Chief Executive Officer of Acella Pharmaceuticals described the results as a critical step forward in the FDA approval process for desiccated thyroid extract, noting the company’s commitment to working closely with regulators to secure Biologics License Application approval.
They also commented that this trial represents real progress in advancing treatment options for people living with hypothyroidism, underlining Acella’s dedication to both scientific innovation and patient choice.
The Need for Effective Hypothyroidism Treatments
Hypothyroidism is a chronic condition caused by insufficient production of thyroid hormones, which play a vital role in regulating metabolism, energy levels, heart function, and brain health.
Symptoms can range from fatigue, weight gain, and depression to cognitive difficulties, making effective treatment crucial for quality of life.
While levothyroxine remains the most widely prescribed option, not all patients feel fully restored on synthetic therapies alone. Desiccated thyroid extracts, which provide both T4 and T3 hormones, have been used for more than a century and continue to serve an important role in treatment.
Expert Endorsement
The Chair of the Department of Medicine at the UConn School of Medicine and UConn Health welcomed the findings, saying these results contribute to the growing body of evidence supporting DTEs as reliable therapies for hypothyroidism.
They expressed that DTEs provide both T4 and T3, and for some patients, this combination offers the relief they do not achieve with synthetic treatments alone, pointing to the unique benefits of DTE products in personalised care.
Acella’s Established Role in the Market
Acella is already a leader in the thyroid treatment market as the maker of NP Thyroid, the most prescribed DTE in the United States. Around 1.5 million Americans rely on desiccated thyroid extracts like NP Thyroid to manage their condition.
The company emphasises that it remains committed to advancing treatment options through domestic manufacturing, scientific research, and ongoing support for patient choice.
Looking Ahead
With positive results from its phase 2 trial, Acella and Neuvosyn are now poised to advance North Star further through the regulatory process.
For patients living with hypothyroidism, the progress signals the possibility of expanded treatment options that may better address individual needs.
In conclusion
The North Star trial results reflect a promising future for desiccated thyroid extract therapies.
By combining scientific progress with patient-focused care, Acella Pharmaceuticals and Neuvosyn Laboratories are charting a course towards improved choice and outcomes in the management of hypothyroidism.
News Credits: North Star shows promise in phase 2 thyroid trial
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