4 June 2025
Perth biotech, Lixa, has successfully completed its first clinical human trial which has confirmed the safety and tolerability of inhaled NeoX-101.
NeoX-101 is the lead molecule in development by the biotech for the treatment of life-threatening superbugs, restoring the effectiveness of first-line antibiotics. The Phase 1 trial focused specifically on an inhaled form of the drug for the treatment of chronic, resistant lung infections - such as those suffered by bronchiectasis, cystic fibrosis and chronic obstructive pulmonary disease (COPD) patients.
The trial, conducted at Linear Clinical Research in Perth, recruited healthy male and female volunteers who inhaled increasing doses of NeoX-101, delivered via a standard nebuliser. At all doses, NeoX-101 was well tolerated and there were no serious adverse events, no negative effect on lung function (measured by spirometry tests) and vital signs remained stable. These results are especially significant as the lungs are very sensitive to the delivery of pharmaceuticals, suggesting that NeoX-101 will have clinical flexibility regarding the range of dosages that can be delivered safely to patients via the inhalation route.
The success of this trial enables progression into subsequent trials investigating clinical efficacy in patients with respiratory infections, taking Lixa a significant step closer towards therapeutic regulatory market approval.
Dr Maud Eijkenboom, Lixa’s CEO, said the trial results show that Lixa has become a clinical-stage biotech, and that they can confidently move forwards to seek regulatory approval for further clinical trials.
“Establishing that NeoX-101 can be safely inhaled is another milestone for Lixa and adds to the already significant data package showing the broad safety and efficacy of this molecule. We are grateful to the volunteers who participated in the study. These results pave the way for our next trial which we expect to examine whether NeoX-101 can work alongside common antibiotics to clear chronic, recurring or untreatable bacterial infections, which are often resistant to conventional treatment. Lixa has also been approached to fast track an oral and intravenous version of its drug, supported by the promising results in this trial.” Dr Eijkenboom said.
Lixa has also recently opened a $5 million capital raising round which will enable the biotech to accelerate its research and development ambitions.
John Poynton AO, Chair of Lixa, said that the Company is generating strong interest from a range of investors including family offices and venture capital firms. “This injection of capital will position the company to accelerate R&D efforts and ramp up manufacturing to actively pursue a range of strategic commercial partnership opportunities in human health as well as in our industrial applications”
About Lixa
Lixa is a Western Australian biotech company with the goal to make any antibiotic work again in resistant or “untreatable” bacterial infections. If successful, the NeoX™ molecules have the potential to become a substantial contributor to the Australian economy by delivering breakthrough antimicrobial solutions across human health, industrial fouling and agribusiness. Importantly, the technology aims for immense humanitarian impact with 39m people being forecast to die by 2050 due to AMR.
By offering a novel, broad‑spectrum, resistance‑breaking mechanism supported by early clinical validation, NeoX™ has the potential to reshape antimicrobial stewardship and provide a practical, scalable response to the global antibiotic resistance crisis.
Contact
Dr Maud Eijkenboom
Managing Director
+61 413 668 531