Check Up: What is the FDA emergency use authorisation, and which ASX stocks were given approval?

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• The FDA has just approved an emergency use authorisation for new Covid-19 vaccines
• What is emergency use authorisation, and which ASX stocks have got it?
• We look at the best and worst performing ASX biotechs over the couple of weeks

On Monday, the US Food and Drug Administration (FDA) approved a new round of vaccines against COVID-19.

The vaccines from Moderna and Pfizer/BioNTech, which were meant for for people 12 years and older, are now authorised under an FDA Emergency Use Authorisation (EUA) for children aged 6 months to 11 years old.

These new vaccines target the most recently found Omicron subvariant called XBB.1.5, which is one of the new emerging variants that we’ve seen come up in the last weeks.

The FDA says children younger than 5 years old may even take multiple doses of this vaccine if they had not previously finished a three-dose series with earlier COVID-19 vaccines.

The XBB.1.5′ strain is prevalent in the US, but has apparently reached Australia too.

Professor Robert Booy from the University of Sydney told SBS News that XBB.1.5 is more transmissible than other sub-variants.

“I call it ‘extra bad boy’,” Professor Booy said.

But Booy says that while XBB.1.5 is causing “large numbers” of infection, the symptoms caused aren’t more serious than other strains.

What is an Emergency Use Authorisation?

The Emergency Use Authorisation (EUA) allows the FDA to make certain medicines, including vaccines, immediately available for sale during public health emergencies.

The process for issuing an EUA is different than a normal FDA approval.

Under an EUA, the FDA authorises uses of medical products based on a “reasonable belief” that the product may be effective, instead of waiting for all clinical trials data.

For the FDA to issue an EUA, there must be no adequate, approved, and available alternative to the candidate product for diagnosing, preventing, or treating the disease.

The FDA established the EUA program in 2004, in response to threats of bio-terrorist attacks which included anthrax at the time.

An EUA status however can be revoked by the FDA at any point as the agency evaluates the most current available data.

Which ASX stocks were granted EUA before?

In recent times, companies on the ASX that have received an EUA status from the FDA include Lumos Diagnostics (ASX:LDX).

Lumos was granted an FDA EUA approval earlier this week for its combined COVID-19/Flu A/Flu B rapid POC test kit, the ViraDx test.

ViraDx was given an EUA as well as a CLIA Waiver (Clinical Laboratory Improvement Amendments) clearance.

What this means is that ViraDx can now be used by US healthcare professionals including healthcare sites operating under the CLIA Certificate.

Lumos says the next step is to offer the product to healthcare providers in the US through its recently established sales channel.

ViraDx meanwhile is a rapid POC test that simultaneously tests for acute respiratory infections using nasal or nasopharyngeal swab samples, and provides a result within 15 minutes.

Another ASX company that had been granted an EUA in the past was Atomo Dianostics (ASX:AT1).

Atomo obtained an EUA from the FDA in June 2021.

The authorisation was given to Atomo’s CareStart, a blood test intended to identify recent or prior COVID-19 infections. Carestart was co-developed with Korean listed company, Access Bio.

Best and worst performing ASX biotechs over the past month

Swipe or scroll to reveal the full table. Click headings to sort.

Visioneering Technologies (ASX:VTI)

The US-based medical device company and producer of the NaturalVue Multifocal 1 Day Contact Lenses announced the appointment of Dr Juan Carlos Aragón as new CEO and executive director, effective 1 October.

Dr Aragón brings over 30 years of leadership in the vision care industry to VTI.

His experience includes senior executive leadership positions in several large international vision care companies, and managing divisions for the Americas, Asia Pacific, and Europe.

Most recently, he was president of CooperVision Specialty EyeCare, which sells soft custom and rigid gas permeable contact lens product offerings.

Clarity Pharma (ASX:CU6)

Clarity announced favourable imaging data from the Phase 2 diagnostic investigator-initiated trial (IIT) of the 64Cu SAR-Bombesin in prostate cancer (BOP trial).

Participants in the BOP trial received the mean dose of 210 MBq of 64Cu SAR-Bombesin and imaged with Positron Emission Tomography (PET) at 1, 3 and 24 hours post-administration of the product.

No adverse events  were reported.

InhaleRx (ASX:IRX)

InhaleRx has reached a significant milestone having recruited and successfully dosed 16 participants across the first and second cohorts of its Phase 1 clinical trial.

The trial is investigating the safety and pharmacokinetics of IRX211, a cannabinoid drug (pure dronabinol) optimised to rapidly deliver a fixed dose via inhalation and address the symptoms of acute pain.

This milestone represents the halfway mark for the Phase 1 trial with two of the four cohorts now complete.

“The safety, tolerability, and pharmacokinetic profile characteristics of IRX211 are looking really promising and the company is delighted by the insights we have from the data received so far,” said CEO, Darryl Davies.

Proteomics (ASX:PIQ)

Proteomics says its subsidiary OxiDx has been granted a patent in Japan for its platform technology to measure oxidative stress.

The patent marks the first of a new family of patents for OxiDx’s next generation diagnostics technology, which will significantly expand its IP (intellectual property) coverage.

Oxidative stress is implicated in over 70 health conditions with levels often reflective of a person’s health and fitness.

Measuring oxidative stress has broad application across multiple markets including as a complementary diagnostic (CDx) test for assessing treatment efficacy, and precision medicine by enabling personalised dosing in clinical trials.

Neurotech (ASX:NTI) 

The company is planning an investor webinar on September 15, where Professor Russell Dale, co-principal investigator for the NTI164 clinical trial in PANDAS/PANS will provide an update.

Earlier, Neurotech said it has concluded the last patient visit at Children’s Hospital at Westmead for the PANDAS/PANS trial.

The trial is investigating NTI164 in children diagnosed with Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS), and Paediatric Acute-Onset Neuropsychiatric Syndrome (PANS).

NTI executive director Dr Thomas says a total of 15 paediatric patients have now successfully completed daily oral treatment with NTI164 over the initial 12 weeks of the trial .

All of the patients are currently continuing to receive treatment under the extension phase (54 weeks) of the trial protocol.

At Stockhead we tell it like it is. While Neurotech is a Stockhead advertiser, it did not sponsor this article.

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