ORTX - Orchard adds ~32% as FDA clears trial for metabolic disorder drug
- Orchard Therapeutics ( NASDAQ: ORTX ) announced Thursday that the FDA cleared its Investigational New Drug (IND) application for OTL-203, targeted at the neurometabolic disease, Hurler subtype of mucopolysaccharidosis type I (MPS-IH).
- Orchard ( ORTX ), a biotech focused on gene therapies, climbed ~32% pre-market in reaction.
- The company plans to evaluate OTL-203 against the standard of care in a global registrational trial, which is expected to start in H2 2023.
- The trial involving patients with MPS-IH will be a multi-center, randomized, active-controlled clinical trial with a primary endpoint measured two years after treatment.
- “Based on data from the proof-of-concept trial, treatment with a single administration of OTL-203 has the potential to address a range of multisystemic manifestations of MPS-IH,” Chief Medical Officer of Orchard ( ORTX ) Leslie Meltzer remarked.
- Read: Seeking Alpha contributor Biologics says, “Orchard is positioned to become a strong competitor in the gene therapy industry for the foreseeable future.”
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Orchard adds ~32% as FDA clears trial for metabolic disorder drug