Proceeds from the financing will be used to progress GB-102, the company’s lead asset, into both a phase 2b clinical study (the ALTISSIMO study) in wet AMD as well as a Phase 2a study in macular edema secondary to DME or RVO. The funding will also be used to advance GB-401, the company’s preclinical glaucoma asset, into the clinic in 2020.
The Series C financing was led by CBC Group (formerly known as C-Bridge Capital), a new investor, and includes participation from existing investors Deerfield Management, OrbiMed Advisors, Hatteras Venture Partners, a fund managed by Blackstone Life Sciences, and other new investors.
Michael Keyoung, MD, PhD, Managing Director and Head of North America at CBC Group, and Chairman of AffaMed Therapeutics, will be joining the Board of Directors of Graybug Vision with immediate effect. “We have great confidence in Graybug Vision’s management team and are excited by the potential of the company’s lead asset, GB-102, to reduce the treatment burden in patients suffering from retinal diseases,” said Michael Keyoung. “We look forward to working with Graybug Vision as they develop GB-102 and continue to advance their pipeline.” Justin Hanes, PhD, a company founder and Lewis J. Ort Professor of Ophthalmology at the Wilmer Eye Institute, will transition to Board observer and continue to actively support the company.
Graybug Vision’s transformative retina and glaucoma clinical programs
GB-102, a pan-VEGF inhibitor, is a potential twice-per-year treatment targeted to alleviate the significant burden of current therapies, and reduce the need for frequent intravitreal injections of currently approved anti-VEGF treatments of wet AMD, DME and RVO. GB-102 completed a Phase 1/2a study (ADAGIO study) in Q1 2019 in which GB-102 met the primary endpoint of safety and tolerability and provided evidence of a durable biological signal. Graybug Vision plans to commence enrollment of the ALTISSIMO study in Q3 2019, a one-year, 220-patient Phase 2b study of GB-102 targeted to achieve dosing every six months in wet AMD. The company also plans to commence enrollment of a six-month Phase 2a study of GB-102 in macular edema secondary to DME and RVO in Q3 2019.
GB-401, an intravitreal injection of the company’s proprietary new molecular entity, is designed to be administered every four to six months in patients with primary open angle glaucoma (POAG). While eye drops, the current standard of treatment for POAG, are effective at reducing intraocular pressure, patients often struggle to administer them once or several times a day, which may lead to vision impairment or loss. GB-401 is anticipated to improve compliance and clinical outcomes with sustained intraocular pressure reductions. Graybug Vision plans to commence enrollment in a Phase 2a study in 2020.
“We are grateful for the strong support from our new and existing investors who share our long-term vision for our company and appreciate the need for long-acting, safe, and effective ocular therapies,” said Frederic Guerard, President and CEO of Graybug Vision. “The need for transforming patient outcomes in clinical practice has never been higher, and we look forward to announcing the initiation of enrollment in two GB-102 phase 2 studies later this year, as well as providing updates on our glaucoma program as it progresses towards a first-in-human study in 2020.”
Source: Company Press Release