Listed in Australia, Incannex Healthcare is developing medicinal cannabis pharmaceutical products and psychedelic medicine therapies. These therapies are being designed to target indications with unmet need, including obstructive sleep apnoea, generalised anxiety disorder, trauma and inflammatory conditions.
Incannex Healthcare announced the initiation of a bioavailability/bioequivalence (BA/BE) study assessing the company’s lead clinical asset IHL-42X. Results from the BA/BE study are a prerequisite to pursue the FDA’s 505(b)(2) new drug application regulatory pathway, which forms a critical part of management’s expedited clinical development strategy for its assets, so we see the commencement as positive preparatory activity. Additionally, management intends to open an investigational new drug (IND) application with the FDA in Q1 CY23 to initiate Phase II/III studies of IHL-42X. Incannex’s clinical strategy is to progress development through later-stage FDA studies, so we view this confirmation from management as encouraging for IHL-42X’s overall development. We continue to value Incannex at US$714.7m or US$11.74 per ADR.
Management’s strategy to pursue synergistic combination patent filings of its assets has the potential to create extensive protection within the cannabinoid treatment market. The IP position for the combinations will be further supported by method of use and formulation patents. Combination patents could therefore be a significant source of value for the company should approval be granted.