Epicrispr Biotechnologies has raised $68m in the initial close of its Series B financing round to commence the clinical trial of its disease-modifying therapy, EPI-321, for facioscapulohumeral muscular dystrophy (FSHD).
The funding proceeds will also aid in supporting the clinical development of this therapy for the genetic neuromuscular disease, and also the ongoing development of the company’s extensive pipeline.
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Ally Bridge Group spearheaded the funding round, which saw contributions from venture philanthropy organisation, SOLVE FSHD.
Other new and current investors also took part in this round.
Additionally, New Zealand’s Medsafe has approved the clinical trial application (CTA) for the therapy’s first-in-human trial.
This approval marks the therapy as the first epigenetic treatment for a neuromuscular condition to enter the clinic.
Set to begin this year, the study will assess the tolerability, pharmacodynamics, safety, and biological activity of the therapy’s single intravenous dose in the adult population with FSHD.
The one-time gene-modulating therapy EPI-321 is designed for “silencing” the DUX4 gene’s aberrant expression.
It has already secured the US Food and Drug Administration’s (FDA) fast track, orphan drug, and rare paediatric disease designations.
Alongside the funding announcement, Epicrispr has welcomed new members, including Andrew Lam from Ally Bridge Group, Intellia Therapeutics Business Development former senior vice-president Jennifer King, and Ultragenyx chief medical officer Eric Crombez.
Epicrispr Biotechnologies CEO Amber Salzman said: “The Series B financing and regulatory clearance to begin our first-in-human trial marks a pivotal milestone as we become a clinical-stage company.
“With a strong investor syndicate and recent FDA designations recognising EPI-321’s potential, our team is laser-focused on advancing EPI-321 into the clinic to provide a much-needed therapy to patients and families in desperate need.”
Epicrispr specialises in gene-modulating therapies, focusing on treatments for neuromuscular diseases. Its Gene Expression Modulation System allows for durable gene expression control, offering treatments for conditions that were previously untreatable.
