Incannex Healthcare is gearing up for an investigational new drug (IND) submission for a Phase IIb generalised anxiety disorder study for its psychotherapy Psi-GAD, says CEO Joel Latham.

“We have been working with the Medicines and Healthcare Products Regulatory Agency (MHRA) and various clinical trial sites in the UK,” said Latham in an exclusive interview with Pharmaceutical Technology. The company is working through onboarding and commencing the site in the UK first and in parallel working with the US Food and Drug Administration (FDA) to open an IND, says Latham. He explains that the trial will be a multi-site, multi-jurisdictional pivotal Phase IIb study. The Sydney, Australia-based company is currently finalising stability data from its manufacturing processes to include in the IND filing.

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Psi-GAD is a psilocybin therapy that treats generalised anxiety disorder by modulating the serotonin system for mood regulation. On 28 February, Incannex released interim data from the initial Phase II Psi-GAD-1 clinical study (ACTRN12621001358831), announcing that the therapy had significantly achieved improvements in the primary endpoint of the Hamilton Anxiety Rating Scale (HAM-A).

In terms of financing, the CEO says that the biotech is in a secure position, partially due to its support from the Australian government. Despite being a Nasdaq-listed company, Incannex runs the majority of its operations in Australia, allowing it to take advantage of the country’s R&D tax rebates. Latham says that for all its R&D spend in Australia, the government offsets 43.5% of the taxation.

This benefit is part of the July 2021-launched Australian R&D tax incentive (R&DTI) program. The 43.5% tax credit initiative is available to pharmaceutical and biotechnology companies that make less than $20 million annually, offering them the chance to lower risk and speed up time to market for their assets. “[The incentive] allows us to manage our cash position quite efficiently compared to most other biotechs globally,” adds Latham.

Businesses that make over $20 million benefit from a slightly lower 38.5% tax credit with the remaining credit carried over to the following year. Suitable R&D activities are defined by the Income Tax Assessment Act 1997.