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Highlights
- HREC has approved Alterity Therapeutics to conduct phase 2 clinical trials of the ATH434 agent in Australia.
- Following the approval, the price of Alterity shares increased by 7.692%.
- The ATH434 agent has the ability to treat MSA and other Parkinson's diseases, as per Alterity.
ASX-listed biotechnology company Alterity Therapeutics Limited (ASX:ATH) announced that it has received approval in Australia to run the phase 2 clinical trials of ATH434. On 13 October 2022, the Australian pharmaceuticals company got a go-ahead from St. Vincent Hospital Melbourne Human Research Ethics Committee (HREC).
Alterity Therapeutics is focused on developing disease-modifying treatments for neurodegenerative diseases; one such treatment is ATH434. As per the company’s announcement, ATH434 will be utilised to treat people with Multiple System Atrophy (MSA). Multiple system atrophy (MSA) is a rare form of degenerative neurological condition that impairs the body’s involuntary (autonomic) functions, including blood pressure and motor control. In addition, enrolment is open at the company’s Sydney-based initial clinical trial site.
Meanwhile, Alterity share prices took a leap on the ASX today amid the approval announcement and closed at AU$0.014 after jumping 7.692%.
Management Commentary
Commenting on the approval, David Stamler, Managing Director & CEO, Alterity, said:
Details about the phase 2 trial
- Clinical endpoints will enable a thorough evaluation of ATH434's effectiveness as well as a characterisation of its safety and pharmacokinetics. Additionally, wearable sensors will make it possible to assess motor characteristics that are crucial for MSA patients.
- Alterity has chosen about 60 adult participants for the trial, who will either get a placebo or one of two dosing levels of ATH434. Participants will get treatment for a full year, giving researchers the chance to monitor changes in efficacy endpoints and improve the design of a conclusive phase 3 study.
Things to know about ATH434
ATH434 is an oral agent intended to prevent pathogenic proteins linked to neurodegeneration from aggregating. ATH434 has shown good potential to treat MSA as well as other Parkinsonian illnesses. Phase 1 studies on ATH434 were completed successfully, revealing the agent's good tolerability and ability to reach brain levels that are comparable to those required for MSA efficacy in animal models. The U.S. FDA and the European Commission have designated ATH434 as an ‘orphan drug’ for treating MSA.
About Alterity Therapeutics Limited
Alterity Therapeutics is a clinical-stage biotechnology company established in 1997 in Melbourne, Australia. The company has offices in Melbourne, Australia, and the USA. Alterity got listed on the ASX in 2000 and on NASDAQ in 2002.
