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InhaleRX (ASX:IRX) has taken a crucial step to initiate research into IRX-616a – the drug candidate it’s developing to treat panic disorder – by executing a Study Order with iNGENū CRO Pty Ltd for the latter to oversee a Phase One clinical trial in Adelaide.
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This follows the Oz biotech company securing $38.5 million in funding from Clendon Biotech Capital for clinical development of several drug candidates, including IRX-616a, through to Phase Three readiness.
The Phase One trial looks to ascertain the tolerability, safety, and efficacy of IRX-616a (a cannabidiol inhaler) among healthy participants, and will take the form of a randomised, double-blind, placebo-controlled, single-ascending dose.
“This execution allows for trial drug manufacturing timelines to be secured, and for the progression of our planning for the commencement of Phase Two trial dosing of healthy subjects later in the year,” CEO Darryl Davie said.
“The board and management are excited to advance IRX-616a into first-in-human trials.”
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He continued: “There are currently no FDA-approved, rapid-onset, inhaled therapies available to PD patients with IRX-616a, presenting as an exciting opportunity to address this very important unmet need.”
IRX moved north on the news to sell at 2.2 cents after a 22.2% spike.
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