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November, 09 2020 • Articles

Stargazer Pharmaceuticals, Inc. Announces $57 Million Series A Financing and Initiation of a Phase 2a Clinical Study of STG-001 in Stargardt Disease Patients

Stargazer Pharmaceuticals, Inc. Announces $57 Million Series A Financing and Initiation of a Phase 2a Clinical Study of STG-001 in Stargardt Disease Patients

Boston, MA; November 9, 2020

Stargazer Pharmaceuticals, Inc., a biopharmaceutical company focused on the development of novel treatment options for rare eye diseases, announced it has completed a Series A financing totalling $57 million from leading investors Novo Holdings, venBio Partners, Canaan Partners and Pontifax to develop its proprietary compound STG-001 for treating Stargardt Disease.  Stargazer also announced the initiation of a Phase 2a study of STG-001 in Stargardt Disease patients.

This Series A financing enables Stargazer to advance development of STG-001 through a pivotal clinical efficacy study potentially leading to a new therapy for Stargardt Disease, a major cause of vision loss in children and young adults.  Stargazer is pleased to be collaborating with Foundation Fighting Blindness (FFB) for the development of STG-001. FFB also participated in this financing round via their investment vehicle, the Retinal Degeneration Fund.

Stargazer was launched by Novo Ventures, the venture arm of Novo Holdings, Gary Sternberg, MD, MBA, who serves as the company’s Chief Executive Officer, and Silvia Ragno, PhD, who serves as the company’s Chief Operating Officer, following licensing of STG-001 from Takeda Pharmaceuticals.

Concurrent with the financing, Richard Gaster, MD, PhD, a Partner at venBio Partners, and Wende Hutton, a General Partner at Canaan Partners, will join Stargazer’s Board of Directors.  They join Nanna Lüneborg, a Partner at Novo Ventures, and Iyona Rajkomar, a Partner at Pontifax.  Other Board members include Daniel J. Curran, MD, from Takeda Pharmaceuticals, John Wagner, MD, PhD, and Dr. Sternberg.

Stargardt Disease is a genetic orphan disease that leads to legal blindness.  It is the most common juvenile macular dystrophy affecting 1 in 8,000 to 1 in 10,000 individuals.  There are currently no therapies available for this disease.  The Phase 2a study of STG-001 is a multi-center study in the US of subjects with Stargardt Disease comparing 2 doses of STG-001 with regard to safety, pharmacokinetics and pharmacodynamics.*

Stargazer has successfully completed a Phase 1 single- and multiple-ascending dose clinical study of STG-001 in healthy volunteers and is planning to initiate a pivotal efficacy study in 2021.

STG-001 has received Orphan Drug Designation in both the US (Food and Drug Administration) and EU (European Medicines Agency).

“This financing from leading investors, as well as the support from FFB, is a testament to the potential of our lead compound, STG-001.  Initiation of the Phase 2a trial in Stargardt Disease patients is an important milestone for us and we look forward to further development of STG-001 for the benefit of Stargardt Disease patients,” said Dr. Gary Sternberg. 

“We are very excited to work with Stargazer to develop a novel and potentially best in class therapy for the treatment of Stargardt Disease, a disease with a high unmet medical need,” said Nanna Lüneborg of Novo Ventures.

About STG-001

The visual cycle is fuelled by uptake of Vitamin A (retinol) from the circulation that is transported by Retinol Binding Protein 4 (RBP4), a key protein that binds retinol in the systemic circulation and delivers it to the eye.

STG-001 is an indirect visual cycle modulator. By reducing plasma concentrations of RBP4 and Vitamin A, STG-001 modulates the visual cycle and the accumulation of cytotoxic retinoids in the eye, potentially reducing the rate of damage to the retina and preserving vision in Stargardt Disease patients.

Stargardt Disease

Stargardt Disease is an inherited retinal degenerative disease that leads to progressive central visual loss and legal blindness.  It is the leading cause of childhood blindness with an estimated prevalence of 50,000-80,000 patients in the US and major European countries combined.  It occurs in 1 in 8,000 to 1 in 10,000 people making it the most common juvenile macular dystrophy.

There is no treatment currently available.  Patients typically exhibit comorbidities, including depression.  Typical onset of disease is generally between 10-20 years of age. 

About Stargazer Pharmaceuticals, Inc.

Stargazer Pharmaceuticals, Inc., is a Boston-based biopharmaceutical drug development company launched in 2018 with a focus on rare diseases of the eye, and an initial focus on Stargardt Disease.  For more information, please visit https://www.stargazerpharmaceuticals.com/

* https://clinicaltrials.gov/ct2/show/NCT04489511?term=stg-001&draw=2&rank=1)