San Francisco, USA; Toronto, Canada; Zürich, Switzerland, May 4, 2023
Endogena Therapeutics Inc., a clinical-stage biotech company, is pleased to announce that it has completed patient enrollment ahead of schedule in its Phase 1/2a trial of EA-2353 for the treatment of retinitis pigmentosa (RP).
With the dose-escalation stage completed in April, the ongoing trial is now in the expansion cohort stage. The trial (NCT05392751) is examining the safety, tolerability, and preliminary efficacy of intravitreal EA-2353, a first-in-class small molecule that selectively activates endogenous retinal stem and progenitor cells to potentially preserve and restore visual function. The trial has enrolled 14 patients with RP due to any pathologic genetic mutation and is being conducted across five US sites.
The first patient started treatment in July 2022 and topline interim data is anticipated in early 2024.
Matthias Steger, PhD, MBA, CEO of Endogena Therapeutics: “Getting this far in a remarkably short time is testament to the outstanding execution of our clinical team in collaboration with InFocus Clinical Research. There’s a tremendous enthusiasm surrounding our trial and completing enrollment ahead of schedule has only been possible thanks to the invaluable contribution of the patients, their families, the investigators and their study staff. We are all driven by the hope of finding a treatment for this rare and devastating disease.”
EA-2353 is a first-in-class small molecule that selectively activates endogenous retinal stem and progenitor cells, which differentiate into photoreceptors and can potentially preserve and restore visual function. This gene-independent treatment approach has significant advantages in RP, which has multiple genetic causes. EA-2353 was granted Orphan Drug Designation by the US FDA in May 2021, and Fast Track Designation in February 2023.
See our YouTube channel for a video explaining how EA-2353 works.
For more information on the clinical trials, please visit www.clinicaltrials.gov (Reference: NCT05392751)
About retinitis pigmentosa (RP)
RP is a serious and debilitating condition. It consists of a group of inherited diseases causing slow and progressive retinal degeneration and loss of vision, for which there is currently no treatment for most patients. It is a leading cause of inherited blindness, with an estimated 1.5 million people worldwide presently affected.
Endogena Therapeutics Inc. is a clinical-stage biotech company that discovers and develops first-in-class endogenous regenerative medicines to repair and regenerate tissues and organs. Its approach has the potential to change the way degenerative conditions related to aging and genetic disorders are treated. The concept is based on the selective regulation of endogenous adult stem- and progenitor-cells for controlled tissue repair by small molecules. Endogena’s most advanced programs target degenerative diseases of the eye, including retinitis pigmentosa and geographic atrophy (secondary to age-related macular degeneration). Endogena is registered in San Francisco, USA, with a head office in Zürich, Switzerland, and a research facility at JLABS in Toronto, Canada.
See our YouTube channel for a video explaining how endogenous regenerative medicine works.
For more information, please visit www.endogena.com
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