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Incannex Engages Curia to Scale-up Manufacture of cGMP IHL-216A
Highlights: Incannex have engaged Curia to scale up cGMP fill-finish manufacture of IHL-216AEngagement of Curia follows achievement of "proof-of-concept"
About this update from Incannex Healthcare Inc.
[{"type":"text","content":"Highlights: \nIncannex have engaged Curia to scale up cGMP fill-finish manufacture of IHL-216AEngagement of Curia follows achievement of \"proof-of-concept\" formulation developmentA patent has been filed on the composition of IHL-216AThe first cGMP batch of IHL-216A manufactured at Curia will be used in a phase 1 clinical trialIncannex is targeting a pre-IND meeting with FDA in Q3 2022 to discuss the most efficient clinical trial development plan to achieve commercialisation for IHL-216A. MELBOURNE, Australia, Aug. 2, 2022 /PRNewswire/ -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), ('Incannex' or the 'Company') a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, is pleased to announce that it has engaged Curia Global, Inc. ('Curia') to further develop and manufacture GMP-grade IHL-216A, Incannex's proprietary inhaled drug product for the treatment of concussion and traumatic brain injury ('TBI').\nEngagement of Curia represents substantial progress in the development of IHL-216A and follows the achievement of compelling results from extensive proof-of-concept studies that were initiated in June 2021 (announced on June 21, 2021). This foundational work established the optimal inhaled formulation of IHL-216A at an experimental scale. Curia is engaged to scale-up the fill-finish manufacture of IHL-216A in compliance with Current Good Manufacturing Practice ('cGMP').\nCuria will also generate data on the quality and stability of IHL-216A to support future regulatory filings, including a US Food and Drug Administration ('FDA') pre-investigation new drug ('IND') package and subsequent IND application. The first cGMP batch manufactured at Curia will be used in a phase 1 clinical trial, which will commence once feedback on the proposed IHL-216A development plan is received from FDA in a pre-IND meeting that Incannex is aiming to set with FDA in Q3 2022.\nIncannex Chief Scientific Officer Dr Mark Bleackley said; \"Scaling up cGMP manufacture of IHL-216A is an exciting step in the development of our product and represents a critical milestone for delivering an inhaled drug, such as IHL-216A. Its manufacture will facilitate investigation of the product in the well-controlled clinical trials we are designing, with feed...