GRAY 9/28: Graybug Vision Reports Analysis of Data from the Six-Month Extension Study of the ALTISSIMO Phase 2b Trial in Wet AMD
September 28 2021 - 07:30AM.
"Graybug Vision, Inc. (Nasdaq: GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve, today provided full-data analysis from the 18-month Phase 2b ALTISSIMO trial of GB-102 for the treatment of wet age-related macular degeneration (wet AMD), Graybug’s proprietary formulation of sunitinib malate injected twice-a-year intravitreally.
The ALTISSIMO trial was a masked and controlled Phase 2b dose-ranging study of two doses of GB-102, 1mg and 2mg, with a single control arm of patients on 2mg aflibercept, conducted across 33 study sites in the United States. The primary endpoint was median time to first supportive therapy with a vascular endothelial growth factor (VEGF) inhibitor, and secondary endpoints were safety and pharmacodynamics, measured as mean change in best-corrected visual acuity (BCVA) and mean change in central subfield thickness (CST) of the retina. As previously reported, the development of GB-102 2mg was terminated in 2020 following an interim safety analysis, and ALTISSIMO was not powered to assess non-inferiority to aflibercept.
ALTISSIMO comprised two phases, the first of which was a 12-month treatment phase, or Core Study, in which GB-102 patients were dosed at Day 1 and Month 6, while a control arm received aflibercept every other month. The second phase of ALTISSIMO was a six-month extended observation phase, or Extension Study, in which patients were monitored without additional treatment to determine the duration of effect measured from their last treatment during the Core Study. Participation in the Extension Study was voluntary, but only patients who completed all study visits, and did not require supportive therapy at their Month 12 visit during the Core Study, were eligible. 58% of the patients who completed the Core Study were eligible and agreed to enter the Extension Study, with 11 patients participating in the GB-102 1mg arm.
By its design, patients could not achieve longer than a six-month duration during the Core Study. The Extension Study provided up to an additional six months for patients to demonstrate longer duration, which resulted in 55% of GB-102 1mg patients experiencing a treatment duration of 12 months or longer, while maintaining visual acuity and central retinal thickness. This is the longest duration ever achieved with an intravitreal injection in a randomized, masked, and controlled clinical trial in wet AMD. In addition, the injection burden was reduced by 73% on an annualized basis for those GB-102 1mg patients who participated in the six-month Extension Study.
As in the Core Study, GB-102 1mg continued to be well-tolerated and maintained a favorable safety profile during the Extension Study. No drug-related adverse events or vision-threatening inflammation were reported.
“The Extension Study gave us our first opportunity to see duration beyond six months in a masked and controlled trial, and we are very excited that the majority of patients volunteering for extended observation achieved a treatment duration of 12 months or longer,” said Parisa Zamiri, MD, PhD, Chief Medical Officer of Graybug. “Furthermore, the significant reduction in injection burden continued throughout the Extension Study and showed that GB-102 1mg has the potential to significantly improve compliance compared to the current standard of care,” Dr. Zamiri concluded.
Graybug continues to optimize its technology platform and is developing additional formulations that have the potential to preserve the durability of GB-102 1mg microparticles while minimizing the risk of dispersion. These new and enhanced formulations, including injectable implants, may also simplify the drug reconstitution process and the injection technique, both of which are sources of variability in clinical outcomes. These innovations have already been incorporated into the development programs of both GB-102 and GB-401. Graybug anticipates that its GB-401 implant program for glaucoma will enter a Phase 1 trial in the second half of 2022. Given the 12-month or longer duration observed with GB-102 in the ALTISSIMO 18-month trial, Graybug decided to stop the further development of GB-103, which was designed to maintain therapeutic drug levels in the retinal tissue for 12 months with a single injection.
“We are encouraged by the Extension Study data that indicate a class-leading durability of GB-102 1mg of 12 months, or longer,” said Fred Guerard, PharmD, Chief Executive Officer, Graybug Vision. “These data further support the significant commercial opportunity that GB-102 1mg could represent. Our search for a partner to fund the further clinical development of GB-102 is ongoing.”
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