• Bod Science provided a ‘landmark update’ on its Phase IIB insomnia clinical trial
  • Neurotech received an ethics approval to begin Phase I/II clinical trial
  • Incannex intends to list all its shares on the Nasdaq


Bod Science provides ‘landmark update’

Cannabis focused biotech Bod Science (ASX:BOD) has provided a ‘landmark update’ on its Phase IIB insomnia clinical trial for a new Schedule 3 cannabidiol (CBD) product for the Australian market.

Bod announced that all patients have now completed the Phase IIB clinical trial – officially completing the final step in R&D (research and development) of the new product.

The trial was being undertaken by Australia’s leading sleep research organisation, the Woolcock Institute of Medical Research, and assessed the efficacy of a uniquely developed Schedule 3 CBD formulation on symptoms associated with insomnia in 198 participants over an eight-week period.

Bod has made the CBD formulation into a unique soft gel format that utilises a patent-protected encapsulation technology which improves the bioavailability of the CBD extract.

The completed clinical trial is the only advanced Schedule 3 (pharmacist only) CBD product candidate for the Australian market. Schedule 3 products can be sold to Australian consumers over-the-counter without a prescription.

Following today’s announcement, Bod says it expects to release top-line results in late August. Once those results are reported, Bod intends to submit the dossier to the TGA for its review.


Neurotech to commence Phase I/II trial

The paediatric neurological disorders-focused biotech Neurotech (ASX:NTI) has received a Human Research Ethics Committee (HREC) approval and Clinical Trial Notification (CTN) clearance from the TGA.

This clearance will pave the way for the commencement of a Phase I/II clinical trial investigating the use of NTI164 in female Rett Syndrome patients. The trial will be conducted across three centres in Australia.

Rett Syndrome is the second leading cause of intellectual disability in girls, with an urgent medical need to develop effective therapies to treat this progressive neurological disease.

“With its positive effects on neuro-inflammation, we believe NTI164 could represent an effective intervention in Rett Syndrome, where mutations in the MECP2 gene are known to exacerbate neuro-inflammation.

Patient recruitment is expected to commence in early Q3 this year, while the preliminary (top-line) results of the trial are anticipated in Q1 2024.


Race Oncology signs deal with City of Hope

Race Oncology (ASX:RAC) has executed a worldwide licence agreement with City of Hope, one of the largest cancer research and treatment organisations in the US.

Under the agreement, Race will exclusively secure rights to a City of Hope patent application and associated know-how.

The aim is to identify whether Race’s lead drug bisantrene may be the most potent inhibitor of the FTO pathway, a human fat mass and obesity-associated protein.

The agreement grants Race freedom to explore and operate under certain City of Hope patent rights.

It will also build engagement with City of Hope as Race progresses its evaluation of bisantrene’s targeted impact on the FTO.


Incannex to list all shares on Nasdaq

Medical cannabis focused company Incannex Healthcare (ASX:IHL) has announced its intention to redomicile its shares to the US.

The company said it will list all its shares on the Nasdaq via a scheme of arrangement.

Incannex shareholders and option holders will be given the opportunity to vote on redomiciling to the US in October. If approved, Incannex will assist shareholders to seamlessly transfer their holdings to US shares tradable on Australia broking platforms.

The company said redomiciling Incannex to the US is not intended as an immediate move to raise capital as the company has approximately $33m in cash reserves as at 30 June.

Rather, the board anticipates that redomiciling to Nasdaq will improve access to large pools of lower cost equity capital over the longer term, as well as align the company with prominent pharmaceutical companies in the US.


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