Marco Taglietti, Scynexis CEO

Scynex­is will pit a new class of an­ti­fun­gals against yeast in­fec­tions — and it won't come cheap

The FDA ush­ered in a new class of triter­penoid an­ti­fun­gals this week, giv­ing Scynex­is the OK for its oral ibrex­a­fungerp — a non-azole treat­ment the com­pa­ny de­signed to de­throne Pfiz­er’s flu­cona­zole in vagi­nal yeast in­fec­tion.

The de­ci­sion came right on time for Scynex­is’ June 1 PDU­FA date, and was based on two Phase III tri­als in which about 50% and 63% of pa­tients giv­en the drug, re­spec­tive­ly, saw all signs and symp­toms of their yeast in­fec­tions dis­ap­pear by day 10.

Just about 29% and 44% of pa­tients on the place­bo saw a clin­i­cal cure by Day 10, ac­cord­ing to da­ta pre­sent­ed at the Amer­i­can Col­lege of Ob­ste­tri­cians and Gy­ne­col­o­gists in April. By Day 25, symp­tom res­o­lu­tion in the treat­ment arms in­creased to 60% and near­ly 74%, Scynex­is re­port­ed.

“This first ap­proval in the U.S. is a ma­jor step to­wards build­ing the ibrex­a­fungerp an­ti­fun­gal fran­chise as we in­tend to lever­age an ex­tend­ed 10-year pe­ri­od of reg­u­la­to­ry ex­clu­siv­i­ty and 14 years of patent pro­tec­tion,” CEO Mar­co Tagli­et­ti said in a state­ment.

Though vagi­nal yeast in­fec­tions — al­so known as vul­vo­vagi­nal can­didi­a­sis (VVC)— af­fect three out of four women across their life­times, the con­di­tion has lim­it­ed treat­ment op­tions. Flu­cona­zole was ap­proved by the FDA as Di­flu­can in 1990, and now has many equiv­a­lents on the mar­ket.

David An­gu­lo

Ibrex­a­fungerp — now mar­ket­ed as Brex­afemme — was ap­proved as a first-line treat­ment, but Tagli­et­ti told End­points News last year that the drug can al­so be used on pa­tients who don’t re­spond to flu­cona­zole, adding that the drug will be priced at a pre­mi­um. At the time, he es­ti­mat­ed the drug would come at a list price of $300 to $400, which would work out to a co­pay of $25 to $30.

CMO David An­gu­lo told the New York Times on Wednes­day that Brex­afemme’s list price will range from $250 to $450. Ac­cord­ing to GoodRx, the av­er­age re­tail price of flu­cona­zole is $29.81.

The drug is al­so be­ing eval­u­at­ed in pa­tients with re­cur­rent VVC in a Phase II study dubbed CAN­DLE. An­gu­lo said on Wednes­day that Scynex­is is “work­ing on com­plet­ing” that tri­al, and ex­pects to sub­mit a sup­ple­men­tal NDA in the first half of 2022.

My­covia could beat it to the punch though, an­nounc­ing on Tues­day that it sub­mit­ted an NDA for its oral an­ti­fun­gal otesec­ona­zole in RVVC. Com­bined Phase III da­ta showed that the drug pro­tect­ed more than 90% of par­tic­i­pants from hav­ing a re­cur­rence for near­ly a year, ac­cord­ing to My­covia.

Back in March, Scynex­is un­veiled in­ter­im re­sults from two open-la­bel Phase III tri­als test­ing oral ibrex­a­fungerp in a range of in­fec­tions. In the first, called FU­RI, the drug was giv­en to pa­tients with dif­fi­cult-to-treat mu­co­cu­ta­neous and in­va­sive fun­gal in­fec­tions that are re­sis­tant to or in­tol­er­ant of cur­rent stan­dards of care, or who re­quire a non-azole oral step-down ther­a­py for the treat­ment of azole-re­sis­tant species. Clin­i­cal ben­e­fit was shown in 86.5% of 74 pa­tients treat­ed, with 46 pa­tients achiev­ing a com­plete or par­tial re­sponse and 18 pa­tients achiev­ing a sta­ble dis­ease re­sponse, ac­cord­ing to the com­pa­ny.

The sec­ond analy­sis, dubbed CARES, in­clud­ed 10 pa­tients who were hos­pi­tal­ized with can­didi­a­sis and can­didemia due to the fun­gus Can­di­da au­ris. The or­gan­ism is of­ten mul­ti-drug re­sis­tant, and re­cent­ly made the CDC’s list of Ur­gent Threats to pub­lic health. Eight of the pa­tients achieved a com­plete re­sponse, ac­cord­ing to Scynex­is.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Janet Woodcock, acting FDA commissioner (Al Drago/Bloomberg via Getty Images)

New Alzheimer's drug ap­proval fall­out: Pub­lic Cit­i­zen seeks re­moval of FDA's Wood­cock, Cavaz­zoni and Dunn

As Capitol Hill begins to wake up to the financial and scientific mess behind the FDA’s approval of Biogen’s new controversial Alzheimer’s drug Aduhelm, nonprofit watchdog Public Citizen is now calling for the top three FDA officials who are responsible to be removed from their positions.

In a letter to HHS Secretary Xavier Becerra on Wednesday, the group highlighted the “litany of flaws” in the FDA’s approval of the new drug, including the “unprecedented, inappropriately close” collaboration between the FDA and Biogen in the analysis of key trial data, basing approval on an unvalidated surrogate endpoint, not following the advice of its expert advisory committee (3 members of which have since resigned), and the wide label that the agency granted.

Endpoints News

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Someit Sidhu, JATT

An­oth­er life sci­ences SPAC has popped up from a small biotech CEO with the help of Take­da, No­var­tis vet­er­ans

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

The SPAC train has slowed down since the extraordinarily high levels from late 2020 into early this year, but Tuesday saw the filing of a new blank-check company targeting the life sciences industry.

Jatt Acquisition submitted its SEC paperwork Tuesday, penciling in an estimated raise of $120 million as it sets its sights on a reverse merger partner. The SPAC is run by Someit Sidhu, a co-founder of Pathios Therapeutics, as well as CEO of Akaza Bioscience and Izana Bioscience. Sidhu will control about 97% of the blank-check company’s shares, per the S-1.

In a first, Re­gen­eron's an­ti­body cock­tail re­duces deaths for a sub­group of hos­pi­tal­ized Covid-19 pa­tients

Scientists have come up with the first evidence that Regeneron’s antibody cocktail, which has so far only been authorized for the outpatient setting, may reduce deaths of hospitalized Covid-19 patients — albeit only a subset.

The combination of casirivimab and imdevimab is the subject of the latest data cut from RECOVERY, the large-scale UK-based trial testing a variety of potential treatments. In total, 9,785 patients hospitalized with Covid-19 were enrolled in this arm of the study and were randomly assigned to receive either usual care plus the intravenous combo or usual care alone.

Barry Greene, Sage CEO

UP­DAT­ED: Sage's sec­ond chance at de­pres­sion hits the PhI­II pri­ma­ry, but ques­tions re­main over dura­bil­i­ty, side ef­fects

Looking to make a comeback after a big Phase III flop, Sage Therapeutics revealed data they believe could change the entire depression treatment landscape, given the vast array of failures in the field. But some results are spooking investors, sending Sage $SAGE shares down early Tuesday.

First, the primary: Sage and Biogen reported Phase III data for once-daily zuranolone Tuesday morning, saying the experimental drug hit its primary endpoint by spurring a statistically significant change from baseline in the 17-item Hamilton Rating Scale for Depression total score. After 15 days, patients in the drug arm saw an average change of -14.1 points, compared to -12.3 on placebo.

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Bio­gen sig­nals a big PhI­II fail­ure as the lead gene ther­a­py in their $800M Night­star buy­out goes down in flames

That $800 million buyout of Nightstar has turned into a bust for Biogen as the lead therapy in the deal failed a pivotal study, signaling a severe setback for the biotech’s ambitions in gene therapies.

The big biotech put out the word after the market closed on Monday that the gene therapy they picked up in the deal for a degenerative blindness called choroideremia failed the Phase III study, just a month after their #2 drug in the deal also flopped in a mid-stage study.

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CEO Harith Rajagopalan (Fractyl)

Af­ter a decade in the type 2 di­a­betes game, Fractyl Lab­o­ra­to­ries recharges with a fresh $100M and a new name

Harith Rajagopalan compared the way type 2 diabetes is managed to sticking your fingers in a dam that’s leaking from a number of places.

You can take drugs to lower your blood sugar, cholesterol, or blood pressure, but you’re not addressing what he says is the core issue — the metabolic abnormality that causes the disease.

“We’re so busy plugging the holes in the dam, we don’t have time to see that the whole infrastructure is at risk,” he said. “That infrastructure is a full-body systemic metabolic abnormality called metabolic syndrome, that we’re ignoring while we’re so busy trying to treat all of the individual symptoms of the condition.”

Michel Sade­lain puts his name and new cell en­gi­neer­ing tech be­hind 'ag­nos­tic' CAR-T start­up chas­ing epi­ge­net­ic anti­gens

It felt natural for Alain Maiore and Sebastian Amigorena to bring in Michel Sadelain as a co-founder of Mnemo Therapeutics. A CAR-T pioneer, Sadelain had been involved as an advisor since the early days — enthusiastic about Amigorena’s work in a genetic knockout that could enhance T cell memory and a new class of potential targets he’s discovered — and could introduce some well-known technologies to the toolbox. So they got the initial cash from Sofinnova Partners to plant roots in Paris and New York in early 2019; within a few months, they began to see more clearly just what the antigen discovery platform might unlock.

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Patrizia Cavazzoni, CDER

FDA’s Cavaz­zoni calls for ad­comms to ‘get back to the sub­stance’

While her comments were recorded prior to the FDA’s recent approval of Biogen’s controversial Alzheimer’s drug, CDER Director Patrizia Cavazzoni presciently called for substantial reforms to the advisory committee process at the agency.

Short on examples of the adcomms she was referring to, Cavazzoni said at a BIO event aired on Monday that some recent committees show “how they can be swayed by emotion in the face of hard facts,” but they need to “get back to the fundamentals, which is listening to thoughtful input from experts in response to thoughtful questions that we ask them.”

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