4D-150 for DME moving to phase 3 trial following positive interim data
Click Here to Manage Email Alerts
Key takeaways:
- Patients who received 4D-150 3E10 vg/eye experienced an 8.4 letter increase in BCVA.
- 4DMT is progressing to a phase 3 trial for 4D-150 3E10 vg/eye.
4D Molecular Therapeutics reported positive interim data from the first part of the SPECTRA clinical trial investigating 4D-150 in patients with diabetic macular edema, according to a press release.
“In the past, intravitreal approaches for sustained delivery via a genetic medicine proved challenging in DME,” Carlos Quezada-Ruiz, MD, FASRS, senior vice president, therapeutic area head, ophthalmology at 4DMT, told Healio. “Today, results from SPECTRA highlight that 4D-150 can potentially help us fulfill our mission to help as many people afflicted with DME see and live better and that intravitreal genetic medicine-enabled care is possible.”
The results include data from 21 patients enrolled at three dose levels of 4D-150 (aflibercept and anti-VEGF-C): 3E10 vg/eye, 1E10 vg/eye and 5E9 vg/eye. The therapy, delivered through a single intravitreal injection, was well tolerated with no intraocular inflammation at any time point, and all patients completed a 16-week topical corticosteroid taper and remained steroid-free, according to the release.
Through 32 weeks, patients in the 3E10 vg/eye arm gained 8.4 letters in best corrected visual acuity with a reduction in central subfield thickness of 194 µm. Patients in this arm also needed fewer supplemental injections compared with those in the 1E10 vg/eye arm.
Based on FDA feedback, 4DMT is moving to a phase 3 trial with the 3E10 vg/eye dose. Part two of SPECTRA is no longer required.
“Further, based on the review of interim data from SPECTRA and PRISM in wet [age-related macular degeneration] and the planned global 4FRONT phase 3 program for wet AMD, the FDA is aligned that a single phase 3 clinical trial is acceptable for [biologics license application] submission in DME,” Quezada-Ruiz told Healio.
4DMT expects the study to include 300 to 400 patients, and the primary endpoint will be BCVA noninferiority compared with on-label aflibercept 2 mg, according to the release.
The 32-week results suggest that 4D-150 will help retina specialists address treatment burden, a major challenge in DME, Quezada-Ruiz told Healio.
“The data from SPECTRA suggest that the sustained delivery of anti-VEGF that 4D-150 enables has the potential to address this unmet need, leading to better vision in the real world,” he said. “This also has a secondary impact on us retina specialists, reducing our environmental footprint and allowing us to serve more patients.”
Collapse
Read more about
Click Here to Manage Email Alerts