SAN DIEGO – Fungal infections, though equally as dangerous as bacterial and viral infections, often fail to secure the attention of high-profile superbugs like methicillin-resistant Staphylococcus aureus (MRSA) or get swept under the rug as a conversation too unseemly to contemplate. Like the late comedian and actor Rodney Dangerfield, they "get no respect," said Tom Chiller, chief of the mycotic disease branch of the Centers for Disease Control and Prevention, during a session at BIO 2017.

"We've done a great job of beating down bacteria, but we haven't done the same with fungus," Chiller said. "So fungal infections continue to remain a major concern and problem," he said.

Topping the list of fear-inducing fungi is Candida auris, an emerging global health threat associated with high mortality, some strains of which are resistant to all three major classes of antifungal drugs. The fungus, which acts like a bacteria in many ways, has been recognized in 86 cases to date in the U.S., is exceedingly difficult to diagnose and can live for weeks or months on patients' skin and hard surfaces.

Slowly but surely, both commercial and legislative efforts to change that picture are unfolding. But the scale of the endeavor isn't large. With executives from Scynexis Inc., Novadigm Therapeutics Inc., Viamet Pharmaceuticals Inc. and Cidara Therapeutics Inc. on stage at BIO, a significant portion of the industry's small but dedicated band of antifungal-focused commercial leaders was on show.

Scynexis' lead candidate, SCY-078, is an oral and intravenous drug for the treatment of several fungal infections, including serious and life-threatening invasive fungal infections. It was recently shown to have in vitro activity against a range of Candida species, including echinocandin-resistant strains. Novadigm's lead development candidate, NDV-31, is a vaccine intended to provide preclinical "cross-kingdom" protection against both fungal and bacterial pathogens. In preclinical studies so far, it has demonstrated protection against both vaginal and bloodstream infections caused by Candida. Viamet's lead antifungal, oral VT-1161 (oteseconazole), met the primary endpoint of a phase IIb trial in recurrent yeast infections, recently, laying the groundwork for the company to finalize its phase III protocol. (See BioWorld Today, June 6, 2017.)

At Cidara, a fourth quarter readout from a phase II trial of I.V.-delivered echinocandin CD-101 is on the horizon. The company is developing it to treat systemic Candida infections and said it could potentially allow for once-weekly I.V. therapy, facilitating shorter and less costly stays in the one place patients most often contract the worst fungal infections: the hospital. As with programs from its aforementioned competitors, Cidara has landed qualified infectious disease product (QIDP) status from the FDA for CD-101. That designation, a product of the Generating Antibiotic Incentives Now Act, has already exerted a positive influence on the quests for antimicrobials. But it's just the start of the legislative incentives that could be implemented in the U.S., Cidara president and CEO, Jeff Stein, told BioWorld.

Stein, who is also chairman of the Antimicrobials Working Group, an industry-led group comprised of emerging antimicrobials companies, said that one of the biggest near-term changes that could help the industry is potential passage of the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act, which incentivizes research and development for the most urgently needed new antimicrobial drugs through increased Medicare reimbursement. If passed, it would change reimbursement for antibiotics from using Diagnosis-related group reimbursement codes to "cost-plus," or New Technology Add-on Payment codes, leading to higher payments for life-saving antibiotics. Having already passed the U.S. House and Senate, the intent is to attach it to an anticipated tax reform bill, Stein said.

Stein also highlighted the Reinvigorating Antibiotic and Diagnostic Innovation Act, which would provide companies developing antibiotics with QIDP status with an R&D tax credit for all the money they've invested from phase I through phase III to develop antibiotics and antifungals that treat a serious or life-threatening infection, as well as for rapid infectious diseases diagnostics. The goal for advocates of the bill is to attach it to PDUFA VI, the industry's must-pass user fee act. (See BioWorld Today, Feb. 15, 2017.)