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.”

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

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