Amplyx Pharmaceuticals’ Fosmanogepix Hits the Mark in Phase II Candida Study

Candida Auris_Compressed

The deadly fungal infection candida auris reared its head this week in a Los Angeles healthcare facility and could be related to COVID-19 cases through the conservation of personal protective equipment strategies.

A combination of COVID-19 and candida auris is something of a perfect storm of infections. Both are difficult to treat, COVID-19 due to the novelty as a disease and the myriad of symptoms it has, and candida auris, which is highly resistant to antimicrobials and is considered one of the highest threats by the U.S. Centers for Disease Control and Prevention. The fungal infection quickly spreads from the contaminated patient and can infect surface areas and more. Last year, in a New York hospital, a patient’s room had to be completely renovated following the death of that patient.

The deadly nature of candida auris, which is part of a family of Candida fungi, and other fungal infections that are resistant to antimicrobials, is why researchers at San Diego-based Amplyx Pharmaceuticals are diligently working to develop a first-line treatment for patients with invasive fungal infections caused by Candida. The company posted Phase II data that showed its experimental asset fosmanogepix demonstrated a treatment success rate of 80%. 

Amplyx Chief Executive Officer Ciara Kennedy told BioSpace in an interview that treatment options for Candida are ineffective and there is a dire need for a new antimicrobial. COVID-19 has shown the world that new vaccines, antibiotics and antimicrobials are highly needed, despite many companies having fled the space. Fosmanogepix, which is being developed both as an intravenous and oral treatment, is a new kind of medication that is showing promise as a treatment for Candida and other types of resistant pathogens highlighted by the CDC in a recent report.

“The question is, will it really do the job?” she posed. So far, the answer seems to be a resounding yes.

With antimicrobial research, Kennedy said animal models have been historically relatable to human outcomes in this setting. The Phase II data provided what Kennedy called a “stellar result,” particularly as some of the drugs used in this space have about a 70% success rate and can come with some safety issues. In the Phase II study, fosmanogepix was well-tolerated with no treatment-related serious adverse events or discontinuations. Full results from the mid-stage study will be presented at an upcoming medical conference.

Not only did it have a strong overall outcome, but Kennedy said patients were able to transition from an intravenous treatment to an oral treatment, which is an important factor. Typically, fungal infections such as the Candida family are contracted in a hospital or long-term care setting. Being able to treat patients intravenously, then discharge them from a hospital with an oral treatment in hand, will be a crucial factor in treating the issue.

“You want to really make sure this infection doesn’t come back,” Kennedy said.

Invasive fungal infections represent a serious threat to millions of patients worldwide, 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.

While the deadly candida auris only hits about 1,000 patient in the United States annually, there are more cases across the globe. Additionally, the broader candida bucket is about 100,000 patients per year with a 30% to 40% mortality rate, Kennedy said.

“We think we have the ideal drug for treating candida auris because of its activity and its safety profile. Our drug is the most active agent against candida auris, irrespective of its resistant profile,” Kennedy said.

In addition to candida, Amplyx is also investigating fosmanogepix are ongoing in patients with serious and life threatening aspergillus and rare mold infections, some of which have high rates of mortality. The emergence of drug-resistant aspergillus added to the watch list for global health threats, underscoring the need for innovation in the development of antifungals, especially those with a novel mechanism of action.

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