West Australian biotech, Lixa, has 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, aiming to restore 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 experienced by patients with bronchiectasis, cystic fibrosis, and chronic obstructive pulmonary disease (COPD).
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.
Lixa said that at all doses, NeoX-101 was well tolerated and there were no serious adverse events, no negative effect on lung function, and vital signs remained stable. It stated that the positive outcome enables progression into subsequent trials investigating clinical efficacy in patients with respiratory infections, taking Lixa a significant step closer to therapeutic regulatory market approval.
CEO Dr Maud Eijkenboom said, “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 company to accelerate its research and development ambitions.
John Poynton AO, Chair of Lixa, added, “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.”