NSW Health Pathology clinician-researcher Professor Sharon Chen has led an international clinical trial of a new drug that could bring hope to patients with fungal infections that do not respond to conventional antifungal treatments.

Prof Sharon Chen and a team of clin­i­cians around the world have col­lab­o­rat­ed on the tri­al of the new drug Olo­rofim, pub­lish­ing the results in the lat­est edi­tion of the pres­ti­gious jour­nal, The Lancet Infec­tious Diseases.

There are cur­rent­ly only four main types, or class­es, of anti-fun­gal drugs licensed and drug resis­tance is becom­ing a grow­ing issue.

Sharon says find­ing new drugs to com­bat fun­gal infec­tions is difficult.

“Because fun­gi are so close­ly relat­ed to humans, you need to use drugs that don’t tar­get humans as well,” she said.

“This drug that was the focus of our study belongs to a new drug class that tar­gets a spe­cif­ic fun­gal enzyme with­out affect­ing its coun­ter­part in humans. There­fore, it can be used selec­tive­ly to treat human infec­tions caused by many mould pathogens such as Aspergillus and impor­tant­ly, a pathogen called Lomen­tospo­ra which is par­tic­u­lar­ly preva­lent in Australia.

“We can see the response rate to this class of drug is very good and it’s treat­ing infec­tions where very lit­tle else works, par­tic­u­lar­ly for immuno­com­pro­mised patients, like some­one with can­cer, or who has had a transplant.

“In addi­tion, if peo­ple are unlucky enough to be involved in a major trau­ma event, like a car acci­dent, or trac­tor injury and they do get one of these fun­gal infec­tions, the mor­tal­i­ty rate is extreme­ly high, up to 90 per cent and where sur­vivors may have severe disability.”

New drug is ‘a game-changer’

There is grow­ing inter­est in fun­gal infec­tions world­wide, par­tic­u­lar­ly in the wake of increas­ing detec­tions among patients with COVID-19 and oth­er res­pi­ra­to­ry viral infections.

The World Health Orga­ni­za­tion (WHO) has pub­lished the first fun­gal pri­or­i­ty pathogens list to guide research, devel­op­ment and pub­lic health action.

Three pri­ma­ry areas for action are pro­posed, focus­ing on:

(1) strength­en­ing lab­o­ra­to­ry capac­i­ty and surveillance;
(2) sus­tain­able invest­ments in research, devel­op­ment, and inno­va­tion; and
(3) pub­lic health interventions.

Sharon says olo­rofim is the first anti­fun­gal in its class and the inter­na­tion­al tri­al which has been con­duct­ed over sev­er­al years, exam­ined its effi­ca­cy in patients with proven inva­sive fun­gal disease.

“The results were very promis­ing, and this drug will be a game-chang­er for patients suf­fer­ing infec­tions that we cur­rent­ly can’t treat with exist­ing anti­fun­gals,” she said.

“This was the first big study to assess the drug’s effec­tive­ness and there are many oth­er sub-stud­ies that will fol­low from it.

“Those stud­ies will hone in on spe­cif­ic pathogens, look­ing at the phar­ma­co­dy­nam­ics, assess­ing how much drug can be giv­en to an adult, or for exam­ple some­one with a liv­er or kid­ney impairment.”

The drug is not yet approved by the Food and Drug Admin­is­tra­tion (FDA), but it is avail­able on com­pas­sion­ate grounds for infec­tions that are not respon­sive to stan­dard anti­fun­gal treatments.

An outstanding commitment to advancing healthcare

“This achieve­ment is a tes­ta­ment to Sharon’s unwa­ver­ing com­mit­ment to advanc­ing health­care,” said Prof David Brown, Direc­tor of NSW Health Pathology’s Insti­tute of Clin­i­cal Pathol­o­gy and Med­ical Research (ICPMR).

“Lead­ing an inter­na­tion­al tri­al of this cal­i­bre, which enables the trans­la­tion of inno­v­a­tive ther­a­py to patients glob­al­ly, is tru­ly out­stand­ing. That she has accom­plished this while also head­ing one of the largest micro­bi­ol­o­gy lab­o­ra­to­ries in Aus­tralia makes it all the more impressive.

“NSW Health Pathol­o­gy remains com­mit­ted to sup­port­ing all our staff and pro­vid­ing the infra­struc­ture needed—not just to sus­tain, but to grow our con­tri­bu­tion to health­care local­ly, nation­al­ly, and glob­al­ly,” Prof Brown said.

Sharon said she was excit­ed to be part of such a sig­nif­i­cant study and to have the sup­port of the Infec­tious Dis­eases Depart­ment and clin­i­cal tri­als unit at West­mead Hos­pi­tal in the West­ern Syd­ney Local Health District.

“It was also vital to have the sup­port of NSW Health Pathology’s lab­o­ra­to­ries to do the fun­gal test­ing and iden­ti­fy eli­gi­ble patients for the study,” she said.

“It’s one of the great aspects of work­ing at a pub­lic pathol­o­gy provider like NSW Health Pathol­o­gy that enables this sort of inno­v­a­tive research work.”

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