Arix Bioscience notes positive clinical data from Amplyx Pharmaceuticals21 Jul 2020 15:01
Arix Bioscience (LON:ARIX)said its portfolio company, Amplyx Pharmaceuticals, has received positive data from its Phase 2 clinical trial of its antifungal agent, fosmanogepix.
The trial, which was set up to evaluate the safety and efficacy of its novel, broad-spectrum antifungal agent fosmanogepix, as a first-line treatment for patients with invasive fungal infections caused by the fungus strain Candida. Fosmanogepix, successfully met its primary efficacy endpoint, demonstrating a treatment success rate of 80%.
Invasive fungal infections represent a serious threat to millions of patients globally, resulting in more than 1.5 million deaths annually and mortality rates ranging from 15% to 65%.
These infections continue to be a global health issue, especially for critically ill patients in hospitals and patients with compromised immune systems, including cancer and transplant patients.
During the trial, patients were treated with fosmanogepix for up to 14 days: 1,000 mg intravenously twice a day for one day, then 600 mg intravenously once daily for at least two days, followed by either 600 mg intravenously once daily or 700 mg orally once daily.?
The clinical-stage biopharmaceutical firm said fosmanogepix was well tolerated by patients during the trial with no treatment-related serious adverse events or discontinuations.
Shares in Arix Bioscience have traded well over the past three months from lows of 81p in May 2020 to 86.5p on Monday afternoon trading following this announcement.
In addition, fosmanogepix demonstrated potent in vitro activity against all Candida isolates obtained from patients in this study, including isolates resistant to other antifungal agents.
Fosmanogepix has received Fast Track and Orphan Drug designations from the US FDA for seven separate indications and is also designated as a Qualified Infectious Disease Product for the treatment of four indications.
“We are very encouraged that fosmanogepix demonstrated a high rate of treatment success, including activity against resistant pathogens, and was well tolerated in patients with invasive Candida infections,” said Michael R. Hodges, Chief Medical Officer of Amplyx.
He added, “The positive efficacy and safety data from this trial continue to highlight the promise of fosmanogepix as a novel and differentiated treatment option for patients who develop life-threatening invasive fungal infections.?
We look forward to advancing the fosmanogepix program in invasive candidiasis towards registration, while continuing our proof-of-concept clinical trials in other invasive fungal infections, including invasive aspergillosis.”
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