[vc_row css=”.vc_custom_1683924209631{margin-right: 20px !important;margin-left: 20px !important;}” el_id=”rp”][vc_column][vc_empty_space height=”40″][vc_column_text]ACTIVELY RECRUITING STUDY

Ongoing Observational Study in Advanced RP

NCT05820100 (actively recruiting), is a multi-center observational study in advanced RP patients [/vc_column_text][/vc_column][/vc_row][vc_row css=”.vc_custom_1683924219226{margin-top: -15px !important;margin-right: 20px !important;margin-left: 20px !important;}”][vc_column][vc_empty_space][vc_column_text]NOT ACTIVELY RECRUITING and COMPLETE CLINICAL STUDIES[/vc_column_text][vc_column_text]

STARLIGHT: Phase 2  6-month Results for MCO-010 in Stargardt

STARLIGHT (6 patients dosed, not actively recruiting), is a Phase 2 trial of MCO-010 in Stargardt patients (NCT05417126).  [/vc_column_text][/vc_column][/vc_row][vc_row css=”.vc_custom_1685654866533{margin-top: -30px !important;margin-right: 20px !important;margin-left: 20px !important;}” el_id=”starlight”][vc_column width=”1/2″][vc_column_text]Efficacy

  • Patients with predominantly macular atrophy experienced clinically meaningful improvements in visual acuity (BCVA)
  • MCO-010 patients exhibited ~ 3 dB gain in mean sensitivity measured by Octopus Visual Field Perimetry
  • High baseline vision-guided mobility (MLYMT) and object recognition (MLSDT) performance was maintained throughout study
  • MCO-010 treated Stargardt patients reported significant improvements in key domain scores of Patient Reported Outcome measures: Reading, Color & Contrast

 

Safety

  • Well-tolerated with no Serious Adverse Events
  • Safety profile consistent with the favorable profile observed in Ph1/2a and Ph2b MCO-010 studies

[/vc_column_text][/vc_column][vc_column width=”1/2″][vc_column_text]Takeaways & next steps

[udesign_icon_font name=”fa fa-check” color=”#2c8e50″ size=”2em”] Potential to address high unmet need: Substantial benefit to patients with vision loss due to Stargardt macular degeneration (no available treatment today)

[udesign_icon_font name=”fa fa-check” color=”#2c8e50″ size=”2em”] Consistency of response: Visual function improvements consistent with MCO-010 Phase 1/2 study and Phase 2b RCT in RP

[udesign_icon_font name=”fa fa-check” color=”#2c8e50″ size=”2em”] Next steps: Engage with FDA and other regulatory agencies on the future of MCO-010, with the goal of expeditiously getting this novel therapy to patients

[/vc_column_text][/vc_column][/vc_row][vc_row css=”.vc_custom_1685654877995{margin-right: 20px !important;margin-left: 20px !important;}” el_id=”restore”][vc_column][vc_empty_space][vc_separator color=”custom” border_width=”3″ accent_color=”#43afa5″][vc_column_text]

RESTORE: Topline Phase 2b Results for MCO-010 in Advanced RP

RESTORE (18 patients dosed, not actively recruiting), is a Phase 2b multicenter, randomized, double-masked, sham-controlled clinical trial in the U.S. for retinitis pigmentosa (NCT04945772). [/vc_column_text][/vc_column][/vc_row][vc_row css=”.vc_custom_1683923118941{margin-top: -30px !important;margin-right: 20px !important;margin-left: 20px !important;}”][vc_column width=”1/2″][vc_column_text]Efficacy

  • 88.9% (16 / 18) of treated patients experienced clinically meaningful 2 or more luminance level improvement in vision-guided mobility (MLYMT) or object recognition (MLSDT)
  • 94.4% (17/18) of treated patients experienced clinically meaningful improvement in MLYMT or visual acuity (BCVA)
  • 100% (18/18) of treated patients experienced clinically meaningful improvement in MLYMT, MLSDT or BCVA
  • Treated patients experienced a clinically meaningful improvement in BCVA by a mean of -0.34 LogMAR

 

Safety

  • Well-tolerated with no serious or severe ocular or systemic adverse events reported
  • One SAE occurred in a placebo treated patient
  • Comparable incidence of TEAEs1across study arms

 

[flat_button text=”Read More About Our Phase 2b RESTORE Trial Results” title=”Flat Button” url=”https://nanostherapeutics.com/2023/04/27/nanoscope-therapeutics-announces-presentation-of-key-results-from-phase-2b-restore-trial-of-mco-010-for-the-treatment-of-retinitis-pigmentosa-at-the-arvo-annual-meeting/” padding=”10px 20px” bg_color=”#31857d” border_color=”#31857d” border_width=”1px” text_color=”#ffffff” text_size=”14px” align=”left” target=”_self”][/vc_column_text][/vc_column][vc_column width=”1/2″][vc_column_text]Takeaways & next steps

[udesign_icon_font name=”fa fa-check” color=”#2c8e50″ size=”2em”] Potential to address high unmet need: Substantial benefit to patients with severe vision loss due to advanced RP (no available treatments today)

[udesign_icon_font name=”fa fa-check” color=”#2c8e50″ size=”2em”] Consistency of response: Visual function improvements and safety profile consistent with previous MCO-010 Phase 1/2 study

[udesign_icon_font name=”fa fa-check” color=”#2c8e50″ size=”2em”] Next steps: Engage with FDA and other regulatory agencies on the future of MCO-010, with the goal of expeditiously getting this novel therapy to patients; File RMAT application April 2023

[/vc_column_text][/vc_column][/vc_row][vc_row css=”.vc_custom_1685654900328{margin-right: 20px !important;margin-left: 20px !important;}” el_id=”phase1″][vc_column][vc_empty_space][vc_separator color=”custom” border_width=”3″ accent_color=”#43afa5″][vc_column_text]

Completed Phase 1/2a Trial  in Advanced RP

NCT04919473 (completed, 11 patients dosed), was a single-center Phase 1/2a clinical trial for retinitis pigmentosa[/vc_column_text][/vc_column][/vc_row][vc_row css=”.vc_custom_1683923118941{margin-top: -30px !important;margin-right: 20px !important;margin-left: 20px !important;}”][vc_column width=”1/2″][vc_column_text]Efficacy

  • 82% (9/11) of treated patients experienced clinically meaningful improvement in vision-guided mobility or visual acuity (BCVA)
  • 64% (7/11) of treated patients experienced clinically meaningful improvement in BCVA
  • Treated patients experienced a clinically meaningful improvement in BCVA by a mean of -0.38 LogMAR

 

Safety

  • Well-tolerated with no serious or severe ocular or systemic adverse events reported
  • Mild to moderate, mainly self-resolving inflammation

[/vc_column_text][/vc_column][vc_column width=”1/2″][vc_column_text]Takeaways & next steps

[udesign_icon_font name=”fa fa-check” color=”#2c8e50″ size=”2em”] First in Human Study: Substantial benefit to patients with severe vision loss due to advanced RP (no available treatments today)

[udesign_icon_font name=”fa fa-check” color=”#2c8e50″ size=”2em”] Favorable Safety: Treatment well-tolerated across subjects, no patients on concomitant medication at week 52

[udesign_icon_font name=”fa fa-check” color=”#2c8e50″ size=”2em”] Promising Efficacy: Visual function improvements across navigational and fine vision metrics[/vc_column_text][/vc_column][/vc_row][vc_row css=”.vc_custom_1685654910053{margin-right: 20px !important;margin-left: 20px !important;}”][vc_column][vc_column_text]1. Treatment emergent adverse events[/vc_column_text][/vc_column][/vc_row]