Nanoscope Therapeutics Receives Fast Track Designation by the FDA for MCO-010 for the Treatment of Retinitis Pigmentosa

Nanoscope Therapeutics Receives Fast Track Designation by the FDA for MCO-010 for the Treatment of Retinitis Pigmentosa

 

DALLAS, TX (October 10, 2022) — Nanoscope Therapeutics Inc., a clinical-stage biotechnology company developing gene therapies for retinal degenerative diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to MCO-010, an ambient-light activatable Multi-Characteristic Opsin (MCO) optogenetic monotherapy to restore vision in blind patients, for the treatment of retinitis pigmentosa (RP) via intravitreal injection.

“The FDA’s decision to grant FTD underscores the importance of MCO-010 to address a serious unmet need and validates its potential as an effective therapeutic for patients with RP,” said Sulagna Bhattacharya, CEO of Nanoscope. “We are proud to have the support of the FDA and look forward to collaboratively interacting with FDA to assess next steps in the clinical development and future regulatory review of MCO-010.”

In January 2022, 27 RP patients with advanced vision loss were enrolled in a multicenter, randomized, double-masked, sham-controlled RESTORE clinical trial (NCT04945772) of MCO-010. Top line data from the clinical trial are expected in H1 2023.

In September of this year, enrollment was completed in the Phase 2 open-label STARLIGHT clinical trial (NCT05417126) of MCO-010 in patients with advanced vision loss due to Stargardt disease. Six-month data from the clinical trial are expected in H1 2023.

The FDA’s Fast Track designation is intended to facilitate the development and expedite the review of novel therapies to treat serious conditions for which there is unmet medical need. With the Fast Track designation, Nanoscope Therapeutics is eligible for more frequent regulatory meetings and communications with the FDA.

About Nanoscope Therapeutics Inc.
Nanoscope Therapeutics is developing gene-agnostic, sight restoring optogenetic therapies for the millions of patients blinded by retinal degenerative diseases, for which no cure exists. The company’s lead asset, MCO-010, is presently in Phase 2b multicenter, randomized, double-masked, sham-controlled clinical trials in the U.S. for retinitis pigmentosa (NCT04945772) with top line data expected H1 2023. The company has also fully enrolled a Phase 2 trial of MCO-010 therapy in Stargardt patients (NCT05417126). MCO-010 has received FDA Fast Track designation for RP and FDA orphan drug designations for RP and Stargardt. Preclinical assets include non-viral laser delivered MCO-020 gene therapy for geographic atrophy.

Investor Contact:
Argot Partners
212-600-1902
Nanoscope@argotpartners.com

SOURCE Nanoscope Therapeutics

Nanoscope Therapeutics, Inc.
Trinity Towers
2777 N. Stemmons Fwy.
Dallas, TX 75207
(817) 857-1186
  • Dr. Samarendra Mohanty, PhD |  Co-Founder & President

    Samarendra Mohanty (Co-Founder/President) is an inventor & serial entrepreneur with 20+ years experience in Biomedical Sciences. He is Co-Founder of several Biotechs and Biomedical device /diagnostic companies (developed & commercialized $100K+ biomedical instruments.)

    Samar obtained M.Tech in Applied Optics from the Indian Institute of Technology-Delhi and a PhD in (Bio)Physics from the Indian Institute of Sciences-Bangalore.

    His extensive Biomedical Technologies experience includes serving as Professor/Senior Scientist at the University of Texas;  University of California, Irvine; Center for Adv. Tech (India); Int. Mol. Biotech (Germany); Univ. Pavia (Italy); NUS (Singapore); and University of St. Andrews (UK). He has authored over 200 international patents and publications in leading journals including Nature and Nature Photonics.

    He is the Principal Investigator for major grants from the National Eye Institute including Audacious Goal Initiative and Bioengineering Research grants. He serves on the editorial board of journals and chairs an international conference on optogenetics. He is the winner of a 2019 Healthcare Heroes award (Fort Worth Business Press), Retinal Organoid Challenge Award, Audacious Goal Initiative Award (NIH), Finalist of Tech Titan, and NIH-Director’s Innovator Award.