InhaleRx is gearing up for a clinical trial in treating panic disorder next year
InhaleRx has developed cannabinoid drug-device combination product IRX616a for treating panic disorder.
InhaleRx (ASX: IRX) is a step closer to clinical trials after appointing Ingenu as the contract research organisation (CRO) for the studies.
The company is developing unique medicinal cannabinoid drug-device products to meet unmet medical needs in treating complex regional pain syndrome and panic disorder.
InhaleRx chairman Sean Williams said Ingenu had been selected following a comprehensive tender process.
“Ingenu was selected on the basis of its capability and experience as a specialist cannabinoid CRO, which enabled it to develop and present an attractive tailored, time efficient and cost-effective approach to IRX’s clinical trial requirements.”
Mr Williams said Ingenu had also provided a “substantially more attractive” offer to InhaleRx on a “value for money basis” than other parties.
“We look forward to working closely with Ingenu over the next 12-18 months as we complete our planned phase 1 and 2 clinical trials for complex regional pain syndrome and phase 2 panic disorder clinical trials.”
Tender process
Ingenu had been selected out of six Asia Pacific and international CRO businesses.
Overseeing the process was a tender committee comprising Mr Williams, fellow InhaleRx non-executive director Dr Andrew Saich, and UK-based clinical trial specialist Ron Budhram assisted as a subject matter expert.
Under the agreement, InhaleRx will pay Ingenu $5 million cash for the complex regional pain syndrome and panic disorder trials.
The appointment is subject to shareholder approval because Ingenu is considered a related party. Ingenu is a subsidiary of InhaleRx’s substantial shareholder Cannvalate.
Additionally, InhaleRx chief executive officer Darryl Davies is chief operating officer and a director of Ingenu.
Upcoming clinical trials
InhaleRx has been working with a UK-based drug formulation specialist to develop medications for complex regional pain syndrome and panic disorder.
The cannabinoid formulations will be dispensed via metered dose inhalers.
Earlier this month, InhaleRx announced it had received valuable guidance following a pre-investigational new drug (pre-IND) meeting with the US Food and Drug Administration relating to development of the drug-device combination product IRX616a, which is the therapy designed for treating panic disorder.
“We are very excited to be working with the Ingenu CRO team, which is highly experienced and regarded as world leaders in conducting cannabinoid and psychedelic clinical trials,” InhaleRx chief scientific officer Dr Rob Jenny said.
“We look forward to commencing the clinical trial program in Melbourne in the new year having finalised the required protocols, investigator’s brochures and trial drug-device formulations over the course of recent months,” Dr Jenny added.