Pfizer Inc. has announced the acquisition of Amplyx Pharmaceuticals, a private biotech company specializing in therapies for immunocompromised patients. The deal centers on fosmanogepix (APX001), a novel investigational antifungal compound currently in Phase 2 clinical development.
Critical Need in Antifungal Treatment
The acquisition addresses a significant medical need, as invasive fungal infections affect more than 1.5 million people globally each year, with devastating mortality rates ranging from 30% to 80%. Despite this burden, no new class of antifungal medications has received FDA approval in nearly two decades.
"The COVID-19 pandemic has starkly reminded us of infectious diseases' devastating impact," said Angela Lukin, Global President, Pfizer Hospital. "We're continuously seeking opportunities to strengthen our anti-infective portfolio, and this acquisition represents a significant step forward in addressing critical fungal infections."
Innovative Treatment Approach
Fosmanogepix represents a potential breakthrough in antifungal therapy, featuring:
- A novel mechanism of action targeting drug-resistant fungal strains
- Broad-spectrum activity against molds, yeasts, and rare molds
- Both intravenous and oral formulations, enabling treatment continuation after hospital discharge
- Demonstrated tissue distribution to critical areas including brain, lung, kidney, and eye
Clinical Development Status
The compound is currently undergoing Phase 2 clinical trials evaluating both intravenous and oral formulations. The studies focus on treating life-threatening invasive fungal infections caused by various pathogens, including:
- Aspergillus species
- Candida species (including resistant Candida auris)
- Fusarium species
- Scedosporium species
Expanded Pipeline Opportunities
Beyond fosmanogepix, the acquisition provides Pfizer with Amplyx's early-stage pipeline, including:
- MAU868: A potential antiviral therapy
- APX2039: An investigational antifungal compound
The transaction builds upon Pfizer's December 2019 equity investment in Amplyx's Series C financing round, where they joined prominent biotech investors including 3×5 Partners, Adage Capital Management, and Arix Bioscience.
While specific financial terms remain undisclosed, the acquisition aligns with Pfizer's strategic focus on developing breakthrough therapies for serious infectious diseases, which currently cause over 8.4 million deaths annually worldwide.
