An­ti­fun­gal drug de­vel­op­er Scynex­is, which burst in­to the zeit­geist as one of the sole US-based com­pa­nies with a Can­di­da au­ris ther­a­py in hu­man tri­als, on Thurs­day dis­closed that the same ex­per­i­men­tal drug had hit the main goal in a late-stage tri­al in pa­tients with vagi­nal yeast in­fec­tions.

The oral drug, ibrex­a­fungerp, was be­ing test­ed in the 376-pa­tient, place­bo-con­trolled VAN­ISH-303 tri­al. Pa­tients en­rolled had ex­pe­ri­enced an acute episode of vul­vo­vagi­nal can­didi­a­sis (VVC), with signs and symp­toms score of four or greater on a scale of ze­ro to 18.

The drug in­duced a ‘clin­i­cal cure’ (de­fined as com­plete res­o­lu­tion — or score of 0 — at the test-of-cure vis­it on day 10), rate of 50.5%, mark­ing a sta­tis­ti­cal­ly sig­nif­i­cant per­for­mance over the place­bo arm (p=0.001), Scynex­is said.

The sec­ondary end­point of my­co­log­i­cal erad­i­ca­tion was al­so met. On the safe­ty side, se­vere ad­verse events were rare, but there were more cas­es re­port­ed in the place­bo group than the ibrex­a­fungerp group, the com­pa­ny added.

An­oth­er twin late-stage study test­ing ibrex­a­fungerp, called VAN­ISH-306, is be­ing con­duct­ed — and da­ta is ex­pect­ed next year. As­sum­ing it is pos­i­tive, re­sults from both tri­als will be used to sub­mit a mar­ket­ing ap­pli­ca­tion in the sec­ond half of 2020. (The drug is al­so be­ing eval­u­at­ing for use in the CAN­DLE study in pa­tients with re­cur­rent VVC — the re­sults are ex­pect­ed in 2021. )

Mar­co Tagli­et­ti Scynex­is

“We be­lieve that ibrex­a­fungerp, as a nov­el, non-azole, oral ther­a­py, can ad­dress large un­met med­ical needs for women with VVC who may not re­spond to flu­cona­zole, the on­ly oral op­tion cur­rent­ly avail­able, which is fungista­t­ic against Can­di­da and al­so has well-doc­u­ment­ed con­cerns around drug-drug in­ter­ac­tions and em­bryo-fe­tal tox­i­c­i­ty for women of child­bear­ing age,” Scynex­is chief Mar­co Tagli­et­ti said in a state­ment on Thurs­day.

Ibrex­a­fungerp, if ap­proved, could end up as the on­ly oral al­ter­na­tive to flu­cona­zole ap­proved for acute VVC in­fec­tions, al­though My­covia is test­ing an­oth­er ther­a­py, VT-1161, for pa­tients with re­cur­rent VVC, Need­ham’s Alan Carr wrote in a note, adding that he ex­pects ibrex­a­fungerp to launch in 2021.

“Our da­ta sug­gest 15% of pts re­turn to their physi­cian be­cause ex­ist­ing treat­ments are in­ad­e­quate…physi­cian in­ter­est in a new drug is high and we es­ti­mate even mod­est (25%) pen­e­tra­tion of the sec­ond-line set­ting gen­er­ates peak sales (for ibrex­a­fungerp) of over $450M.”

It has been decades since a fresh fam­i­ly of an­ti­fun­gals has come on to the mar­ket — at the mo­ment there are three class­es of an­ti­fun­gals in clin­i­cal use, in­clud­ing azoles and echinocan­dins. The most pop­u­lar an­ti­fun­gals in use to­day were in­tro­duced in the 1980s and this class is in­creas­ing­ly los­ing its po­ten­cy, as fun­gal pathogens be­come more re­sis­tant.

Scynex­is’s ibrex­a­fungerp be­longs to a new class of an­ti­fun­gals called glu­can syn­thase in­hibitors, and has shown to be ef­fec­tive against a broad range of fun­gal in­fec­tions, in­clud­ing re­sis­tant strains, Tagli­et­ti told End­points News in a pri­or in­ter­view.

One of the biggest chal­lenges fac­ing the field of an­ti­fun­gal drug de­vel­op­ment is the lack of in­cen­tives, such as those af­ford­ed to com­pa­nies in the an­tibac­te­r­i­al and an­tivi­ral space, he said, adding that when Scynex­is ap­proached BAR­DA for fund­ing, they were told an­ti­fun­gals were not a pri­or­i­ty in Wash­ing­ton.

“I hope this aware­ness will now reach Wash­ing­ton.”

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