• Invex receives IND approval from the US FDA
  • Antisense reveals positive study in Long Covid-19
  • Bod gets US certification

Invex Therapeutics (ASX:IXC) jumped 20% this morning after receiving a Investigational New Drug Application (IND) approval for Presendin from the FDA to commence the IIH EVOLVE Phase III clinical trial in the US.

Presendin is Invex’s lead candidate and a potential drug used to treat Idiopathic Intracranial Hypertension (IIH).

The Phase III clinical trial will be a randomised, placebo-controlled, double-blind trial that will randomise 240 patients with newly diagnosed IIH.

The aim of the trial is to determine the efficacy and safety of Presendin versus placebo, administered once weekly over 24 weeks.

The primary endpoint of the trial is the change in intracranial pressure from baseline, with key secondary endpoints related to vision and headache outcome measures.

The trial was designed to specifically meet the requirements for market approval of Presendin for the treatment of IIH in the EU, UK and Australia.

Invex intends to open up to 40 clinical sites globally.

“The outcomes of this trial have the potential to transform the lives of thousands of IIH patients living with the significant burden of this disease, where there are no existing regulatory approved drug therapies,” said Dr Jason Loveridge, chairman of Invex.

“Many patients see their disease progress to a stage where invasive neurosurgical and ophthalmic surgeries are required to alleviate severe headaches, and prevent permanent blindness.”


Invex share price today:


Antisense’s Long Covid-19 study results

Antisense Therapeutics’ (ASX:ANP) share price also jumped over 20% this morning.

The company reported that outcomes from a collaboration to study the neurological aspects of Long COVID-19 have identified novel blood markers as potential diagnostic and therapeutic targets.

The study was done between Antisense and US-based researchers led by global leader in the field, Dr Igor Koralnik, at the Northwestern Medicine Neuro-COVID clinic in Chicago.

Under the collaboration, blood samples were collected from Long COVID-19 patients who had not been hospitalised.

These samples were then used to generate data on up to 7,000 proteins in the blood utilising a large-scale protein analysis known as proteomics.

The analysed data has identified a number of proteins that are significantly modulated in the blood of Long COVID-19 patients when compared to patients who had recovered from Long COVID-19 infection.

These identified proteins can now be used as diagnostic markers which could assist in the identification of Neuro Long Covid patients for better designed clinical trials, and potentially for earlier treatment intervention.

Antisense is now looking to further explore the clinical potential of lead drug ATL1102 in this setting via applying for grant funding opportunities.

The company also intends to review its patent applications with targeted pharmaceutical and diagnostic companies for potential commercial discussions.


Antisense share price today:


Bod gets US hemp certification

Certification has been awarded by the US Hemp Authority for BOD Australia’s (ASX:BOD) exclusive CBD extract and related products under its CBll, H&H CBD brands sold in the US.

Getting this approval has taken the company over 12 months which included a stringent verification process.

Verifications were made against BOD’s CBD extract, lab testing of Bod’s products for multiple contaminants, THC limits, as well as ensuring the company’s operations do not utilise synthetic cannabinoids.

These tests were undertaken by a third-party to ensure independence.

The US Hemp Authority is an independent self-regulatory organisation focused on ensuring the US industry maintains the highest standards and best practices.


BOD Australia share price today: