Methicillin-resistant Staph aureus (Shutterstock)

FDA grants ‘break­through’ sta­tus to an­tibi­ot­ic al­ter­na­tive as Con­tra­Fect rush­es to join fight against su­per­bug

An ex­per­i­men­tal drug that promis­es to be the first an­ti-in­fec­tive agent to prove su­pe­ri­or to van­comycin — an an­tibi­ot­ic ap­proved in 1958 — has notched the FDA’s “break­through” sta­tus.

Roger Pomer­antz

Con­tra­Fect said the des­ig­na­tion was based on Phase II da­ta in which exe­ba­case was test­ed against a su­per­bug known as me­thi­cillin-re­sis­tant Staph au­reus, or MR­SA. In a sub­group analy­sis, the clin­i­cal re­spon­der rate at day 14 was 42.8% high­er than that among those treat­ed with stan­dard of care, the com­pa­ny said (p=0.010).

The 21% re­duc­tion in 30-day all-cause mor­tal­i­ty, how­ev­er, was not sta­tis­ti­cal­ly sig­nif­i­cant with p=0.056.

Demon­strat­ing su­pe­ri­or­i­ty marks a first for the MR­SA field, em­pha­sized Roger Pomer­antz, who jumped from Seres to be­come CEO for Con­tra­Fect last April. Al­ler­gan’s Dal­vance, a struc­tur­al rel­a­tive to van­comycin, was ap­proved based on non-in­fe­ri­or­i­ty.

Con­tra­Fect is now con­duct­ing a piv­otal Phase III study to ex­am­ine exe­ba­case’s ef­fi­ca­cy in all in­fec­tions caused by Staph au­reus, in­clud­ing right-sided en­do­cardi­tis.

Cara Cassi­no

“Based on our in­ter­ac­tions with the FDA re­gard­ing stream­lined de­vel­op­ment of exe­ba­case, this sin­gle Phase 3 study, in ad­di­tion to the full pack­age of da­ta gen­er­at­ed to date, may serve as the ba­sis of a Bi­o­log­ics Li­cense Ap­pli­ca­tion for FDA re­view and po­ten­tial ap­proval of exe­ba­case,” CMO Cara Cassi­no said in a state­ment.

MR­SA, which com­pris­es a group of Gram-pos­i­tive bac­te­ria, can cause in­fec­tions in the skin, the heart, the res­pi­ra­to­ry sys­tem, bone and joint, and even the cen­tral ner­vous sys­tem.

Michael Messinger

Tak­ing a page from bac­te­rio­phages — virus­es that in­fect bac­te­ria — Con­tra­Fect’s drug is a cell wall hy­dro­lase en­zyme, or lysin, that in­duces bac­te­r­i­al death by punc­tur­ing the cell wall. Its in­ven­tor, Vin­cent Fis­chet­ti of Rock­e­feller Uni­ver­si­ty, calls it an an­tibi­ot­ic al­ter­na­tive.

The com­pa­ny fore­casts a $700 mil­lion mar­ket for the MR­SA bac­teremia in­di­ca­tion pro­vid­ed that exe­ba­case de­liv­ers in Phase III and gets the su­pe­ri­or­i­ty la­bel, CFO Michael Messinger told End­points News. They are al­so gun­ning for an ex­pand­ed la­bel cov­er­ing all Staph au­reus.

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.

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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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Lynn Fitch, Mississippi Attorney General (Rogelio V. Solis/AP Images)

Mis­sis­sip­pi sues Eli Lil­ly, Sanofi and No­vo over in­sulin prices as in­ter­change­able biosim­i­lars may ar­rive soon

Mississippi Attorney General Lynn Fitch last week sued the top three insulin manufacturers, which collectively cover almost the entire US insulin market, alleging that they’ve colluded to raise their prices in lockstep, and in some cases by more than 1,000% for drugs that are decades old.

“Because of Manufacturer Defendants’ collusive price increases, nearly a century after the discovery of insulin, diabetes medications have become unaffordable for many diabetics,” the lawsuit says.

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