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.”

Magenta Therapeutics is pausing an early-stage clinical trial after a patient died. The death was deemed to be possibly related to its drug, MGTA-117.

The biotech said the pause of the Phase I/II trial is voluntary and gives it time to review all available data before deciding what to do next. It’s also reported the known information to the FDA.

The dose-escalation trial was designed to test whether MGTA-117, an antibody-drug conjugate, could serve as a more targeted alternative to high-intensity chemotherapy as a conditioning agent for cancer patients who are set to receive a stem cell transplant. It recruited patients with relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome.

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

Bristol Myers Squibb is looking to expand Breyanzi into more indications — and the pharma’s newest data readout makes progress on that front.

The Big Pharma put out word Thursday that the CAR-T cell therapy met the primary endpoint of complete response rate compared to historical control in a subset of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) that were refractory to a BTK inhibitor and pretreated with a BCL-2 inhibitor.

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

Aridis Pharmaceuticals’ monoclonal antibody missed the bar in a Phase III test in ventilator-associated pneumonia caused by the gram-positive bacteria S. aureus, the company announced Wednesday. 

But Aridis is planning for a second Phase III study anyway once it discusses the findings with the FDA and the European Medicines Agency. Execs blamed recruitment challenges stemming from Covid-19 and Russia’s invasion of Ukraine for the miss, cutting their enrollment target in half.

XyloCor Therapeutics says patients with heart disease who got its gene therapy could exercise for longer and had fewer chest pain attacks. The biotech announced it completed a Phase I/II trial of the gene therapy Thursday morning, and plans to move forward with a pivotal trial.

In the Phase II portion of the trial, 28 patients with angina (or chest pain) caused by coronary artery disease and who had no other treatment options were enrolled and were given the highest tested dose from the first part of the trial. Patients were followed for six months.