• Living Cell files a patent for CBD-based dementia drug
  • Antisense’s study results show effectiveness in Duchenne muscular dystrophy
  • Incannex completed a pre-Investigational New Drug Application with the FDA


Living Cell files a patent for cannabis-based dementia drug

Living Cell Technologies (ASX:LCT) has filed a provisional patent application over a cannabinoid (CBD)-based combination drug, known as AI-116, for the treatment of dementia.

The filing of a provisional patent application establishes the priority date of the invention ahead of potential competitor companies.

So far, there has been no development of a cure for the diseases that cause dementia. The global dementia drugs market size was valued at more than US$8.7b in 2021, and is projected to reach US$19.7b by end of this year.

LCT is also in advanced discussions with a major Australian university over a research agreement to perform pre-clinical studies, including comparing the efficacy of AI-116 to existing registered drugs used to treat dementia.


Antisense’s drug effective in muscular disease

Antisense Therapeutics (ASX:ANP) rose 5% this morning after its study demonstrated the potential for ATL1102 (in combination with dystrophin restoration drugs) to improve therapeutic outcomes for Duchenne muscular dystrophy (DMD).

The result shows that improved muscle strength was detected following combination of a mouse CD49d (ATL1102 to human) with a dystrophin exon skipping restoration agent (DSER).

In addition, RNA-seq transcriptomics results support the role of ATL1102, as a mono-therapy and in combination with a DSER, in reducing inflammation and augmenting muscle recovery.

“These study results are exciting, and suggest the potential for ATL1102 in combination with dystrophin restoration drugs to improve therapeutic outcomes in DMD patient,” said Dr George Tachas, Antisense’s director of Drug Discovery and Patents.


Clarity Pharma progresses to final cohort

Radiopharmaceutical company, Clarity Pharmaceuticals (ASX:CU6), announced the successful completion of cohort 3 in the theranostic 64Cu/67Cu SARTATE neuroblastoma trial.

Following this completion, Clarity is progressing to the final cohort in the  trial, where the highest dose in the dose escalation phase of the trial is administered.

Recruitment of cohort 4 is now open at clinical sites in the US at the increased dose level of 375MBq/kg body weight.


Incannex completes meeting with FDA

Meanwhile, Incannex Healthcare (AXX:IHL) said it has completed a constructive pre-Investigational New Drug Application (pre-IND) meeting with the US FDA for its proprietary drug product IHL-675A for treatment of rheumatoid arthritis.

The meeting discussed the formulation developed by Incannex, as well as an overview of the proposed clinical development plan.

Opening an IND is required to conduct trials in the US, and ensures that trials are designed so they meet the data requirements necessary for FDA marketing approval.

The FDA had previously confirmed to Incannex that no further nonclinical studies are needed for the IND application.

The regulator had also provided specific guidance on what is required for Incannex to submit an NDA via the 505(b)(2) pathway.


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