Spying a chance to stop a ‘catastrophic threat,’ VCs funnel $67M into Amplyx to trial a broad-spectrum antifungal

Amplyx thinks its lead candidate may treat emerging superbug Candida auris

Amplyx Pharmaceuticals has raised $67 million to fund antifungal R&D. The series C sets Amplyx up to take its lead broad-spectrum antifungal candidate into phase 2 later this year.

Sofinnova Venture Partners led the round with support from fellow new investors Lundbeckfonden Ventures, Arix Bioscience and Pappas Capital. Amplyx also secured money from the investors that participated in its $49 million series B round about 18 months ago, namely 3x5 Partners, BioMed Ventures, New Enterprise Associates and RiverVest Venture Partners.

The series C equips Amplyx’s experienced management team to forge ahead with development of oral and intravenous formulations to address the major emerging problem of drug-resistant fungal infections. 

Amplyx’s lead candidate, APX001, is designed to treat infections caused by common, sometimes drug-resistant, fungi such as species of Candida and Aspergillus. And also kill rarer molds, including Fusarium, Scedosporium and those from the Mucorales order. 

If APX001 shows such broad efficacy in clinical trials, it will free physicians from the challenge of identifying the fungus before treatment. This is particularly important for the emerging superbug Candida auris, which the former acting head of the CDC called a “catastrophic threat” earlier this year. The fungus is hard to identify and resistant to existing drugs. This has led to big problems for healthcare systems.

“Since April 2015, an adult critical care unit in England has been managing an outbreak of C. auris, with more than 40 patients either colonized or infected. The hospital outbreak has been difficult to control, despite enhanced infection control interventions, including regular patient screening, environmental decontamination and ward closure,” Public Health England wrote last summer.

San Diego, CA-based Amplyx is yet to test the efficacy of APX001 against C. auris or any other fungus in humans. But its preclinical data suggest the drug's targeting of an enzyme vital to the development of multiple fungal species, GWT1, will result in efficacy against the superbug and other strains. 

“We think this has great properties for a first-line therapy. We have great activity across [many] strains of Candida and Aspergillis,” Amplyx CEO Ciara Kennedy, Ph.D. told Xconomy. 

Kennedy took over as CEO at the start of the year, having previously served as COO. In that role, Kennedy oversaw the advance of oral and intravenous formulations of APX001 into the clinic. Amplyx is yet to publicly share data from the studies of the safety and pharmacokinetics of APX001 in healthy volunteers. But whatever it has learnt set it up to raise the series C round.

The investors have committed the cash to a company at the forefront of an emerging public health issue with a management team that has a track record of landing buyout bids. 

Kennedy worked as COO of Lumena Pharmaceuticals in the run up to its $260 million takeover by Shire. The Lumena CEO at the time of the Shire buyout, Mike Grey, helmed Amplyx before stepping aside for Kennedy. 

Grey, who now serves as executive chairman of Amplyx, has a history of leading companies to takeovers. The executive was in charge at SGX Pharmaceuticals and Trega Biosciences when they attracted offers from Eli Lilly and Lion Bioscience, respectively. And occupied the executive chaIrman’s seat at Ziarco Pharma when it parlayed mixed mid-phase data up into as takeover by Novartis.  

Kennedy and Grey are now once again working with a small team based out of San Diego. Like Lumena at the time of the Shire deal, Amplyx is yet to grow its headcount above 20, although that will change as it makes a handful of hires over the next six months, The San Diego Union-Tribune reports