4DMT Presents Positive Interim Data from Randomized Phase 2 PRISM Clinical Trial of Intravitreal 4D-150 Demonstrating Favorable Tolerability & Clinical Activity in Wet AMD - Seite 2

“We are pleased by the robust clinical activity demonstrated in this severe disease activity patient population with high treatment burden. We believe these positive interim Phase 2 results demonstrate a differentiated product profile for the treatment of wet AMD, including in these most difficult to treat patients that have not been studied adequately in prior clinical trials,” said Robert Kim, M.D., Chief Medical Officer. “We look forward to discussions with regulators to align on a Phase 3 development plan expedited by FDA RMAT and EMA PRIME designations to advance 4D-150 with the goal of providing a compelling new treatment option for millions of patients suffering from these blinding VEGF-driven retinal diseases.”

“Wet AMD is a chronic disease, and many of our patients require long-term, frequent intravitreal injections. Unfortunately, under-treatment and suboptimal disease control contribute to vision loss in the real world," said Arshad M. Khanani, M.D., M.A., FASRS, Director of Clinic Research at Sierra Eye Associates, Reno, Nevada. "I am encouraged by the potential of a one-time intravitreal injection of 4D-150 for treating wet AMD. Results from the Phase 1 and interim results from Phase 2 cohorts of the PRISM study confirm that 4D-150 is well tolerated and maintains stable visual acuity in previously treated high-need patients. 4D-150 also significantly reduces treatment burden while effectively controlling disease activity without fluid fluctuations. I believe 4D-150 has the potential to revolutionize the treatment approach for our patients with wet AMD, and I am looking forward to participating in the Phase 3 trials."

Phase 2 PRISM Clinical Trial Dose Expansion Cohort Background & Summary Baseline Characteristics

The Dose Expansion cohort of the PRISM study is a randomized, controlled Phase 2 clinical trial evaluating 4D-150 in previously treated wet AMD patients with severe disease activity (≥325 µm central subfield thickness (CST) measured by optical coherence tomography (OCT) and presence of subretinal or intraretinal fluid) and a high treatment burden (≥6 anti-VEGF injections in the prior 12 months).

The trial enrolled 51 patients with severe disease activity and treatment burden:

• Mean CST: 442 µm
• Mean anti-VEGF injections in the prior 12 months (actual): 9.6
• Mean time since diagnosis (years): 3.1
  

Enrolled patients were randomized 2:2:1 to receive a single high (3E10 vg/eye) or low (1E10 vg/eye) intravitreal dose of 4D-150 or intravitreal aflibercept 2 mg every 8 weeks (control).