Arix Bioscience notes positive Phase I clinical and non-clinical data from Amplyx for the treatment of life-threatening fungal infections

10th October 2017

LONDON, 10 October 2017:

Arix Bioscience plc (LSE: ARIX) (“Arix Bioscience”), a global healthcare and life science company supporting medical innovation, is pleased to note the release of positive clinical and non-clinical data by Amplyx Pharmaceuticals (“Amplyx”), an Arix Bioscience Group Business, at IDWeek 2017, held in San Diego, CA.

The data showed that Amplyx’s lead candidate APX001, a novel, broad-spectrum drug in development for the treatment of potentially life-threatening fungal infections, was well-tolerated in patients with a favourable safety profile and demonstrated non-clinical efficacy against a broad range of pathogenic fungi including the deadly Candida auris and Aspergillus.

Data from two Phase I clinical studies, with a total of 166 subjects enrolled, showed that both intravenous and oral formulations of APX001 were safe and well tolerated across all doses tested. Target exposures of APX001 for efficacy against Candida and Aspergillus were significantly exceeded, with an average plasma half-life of ~2.5 days. The oral formulation achieved greater than 90% bioavailability.

Additional data from five non-clinical studies showed that APX001 demonstrated efficacy against a range of pathogenic fungi. Notably, 16 strains of Candida auris were more susceptible to APX001 than other antifungal agents, and immunocompromised mice treated with APX001 were observed to have a significantly higher percentage survival compared with the drug anidulafungin.

Joe Anderson, Chief Executive Officer of Arix Bioscience, commented: “The data presented by Amplyx show the safety and tolerability in patients and pre-clinical efficacy of APX001 for the treatment of potentially life-threatening fungal infections. This is an area of serious unmet need, particularly given the increasing threat from multidrug-resistant strains such as Candida auris. This data further reinforces our belief in the potential of the treatments Amplyx is developing to transform the lives of patients with few or no other options.”

Joe Anderson, Chief Executive Officer of Arix Bioscience