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Amplyx reports early signs antifungal drug clears Candida blood infections

San Diego Union Tribune logo San Diego Union Tribune 9/18/2019 By Bradley J. Fikes, The San Diego Union-Tribune

An antifungal drug demonstrated early signs of effectiveness in human testing, San Diego biotech Amplyx Pharmaceuticals said Monday.

Privately held Amplyx also said it has acquired rights to another drug in testing to prevent a viral infection related to organ transplants.

The antifungal drug, fosmanogepix, showed effectiveness in 10 patients treated in the mid-stage or Phase 2 trial, said Ciara Kennedy, president and CEO of Amplyx. Another 10 remain to be treated in the study, which did not use a placebo.

Fosmanogepix was tested for effectiveness against candidemia, the presence of the Candida fungus in the blood. Patients who are extremely ill or immuno-compromised are most at risk. Those with healthy immune systems are generally not vulnerable.

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Most of the patients developed infections following very complicated invasive procedures, Kennedy said. And once the infection takes root, it’s very hard to clear.

Kennedy said current antifungal treatments are losing effectiveness, similar to the spread of bacterial resistance. Moreover, existing drugs are often toxic.

“Fosmanogepix has efficacy against resistant pathogens and hard-to-treat mold infections, so we have the opportunity to do better on safety and efficacy,” Kennedy said.

While the trial is small, the seriousness of candidemia makes it easy to gauge effectiveness, she said.

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“Candida infection in the bloodstream won’t just clear up on its own,” she said. “And secondly, if you don’t address that infection, that patient’s going to die. So those are some pretty black-and-white endpoints when it comes to clinical trials.”

The drug acts by a new mechanism, which has previously been validated in animal testing, Kennedy said. It inhibits a fungal enzyme called Gwt1 that is necessary to growth.

Amplyx said preclinical studies have demonstrated widespread activity against many species of Candida and Aspergillus, including drug-resistant strains such as Candida auris. In addition, it’s active against difficult mold infections including Fusarium and Scedosporium.

“The animal data, more often than not, translates to clinical data,” Kennedy said.

The drug in testing that Amplyx acquired complements fosmanogepix, she said. Called MAU868, it’s an antibody drug for treatment of BK virus infection.

“A large proportion of the patients that we target with fosmanogepix are the same patients that are vulnerable to BK disease,” Kennedy said.

Amplyx purchased worldwide rights to MAU868 from Novartis for an undisclosed sum.

BK virus is common, but usually harmless except in the immune-compromised. Kidney transplant patients commonly get immune suppression, and in these patients BK virus can cause loss of the kidney. Other cases include those who have received immune suppression for bone marrow transplants.

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Amplyx intends to start midstage or Phase 2 trials of MAU868 in the near future, Kennedy said.

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©2019 The San Diego Union-Tribune

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