Iterum's fu­ture looks un­cer­tain, af­ter lead an­tibi­ot­ic fails con­sec­u­tive piv­otal stud­ies

While the mar­ket for an­tibi­otics re­mains in tat­ters — un­like many of its bank­rupt (or at the brink of bank­rupt­cy) peers — Iterum is suf­fer­ing not be­cause its an­tibi­ot­ic isn’t sell­ing, but be­cause the com­pound has now failed back-to-back late-stage stud­ies.

The ex­per­i­men­tal drug, su­lopen­em, was de­signed to tack­le drug-re­sis­tant in­fec­tions with an out­pa­tient fo­cus (in ad­di­tion to hos­pi­tals), to avert those re­im­burse­ment chal­lenges that in­cen­tivize hos­pi­tals to pre­scribe cheap­er, gener­ic broad-spec­trum an­tibi­otics.

On Mon­day, the com­pa­ny dis­closed the lat­est late-stage fail­ure in a 1,395 pa­tient-tri­al eval­u­at­ing the use of the drug in com­pli­cat­ed uri­nary tract in­fec­tion (cU­TI) months af­ter su­lopen­em failed a piv­otal study in com­pli­cat­ed in­tra-ab­dom­i­nal in­fec­tions (cIAI).

In the cU­TI tri­al, the main goal of the study was the over­all clin­i­cal and mi­cro­bi­o­log­ic re­sponse on day 21. Pa­tients were ini­tial­ly giv­en five days of in­tra­venous su­lopen­em, fol­lowed by oral su­lopen­em to com­plete sev­en to ten days of treat­ment — or giv­en in­tra­venous er­tapen­em (a Mer­ck an­tibi­ot­ic) fol­lowed by gener­ic oral broad-spec­trum an­tibi­otics.

On day 21, re­spon­der rates on the su­lopen­em arm were 67.8% (301 of 444 pa­tients) — in the er­tapen­em group, the re­spon­der rates were 73.9% (325 of 440 pa­tients). That worked out to a dif­fer­ence of -6.1% (95% con­fi­dence in­ter­val -12.0%, – 0.1%).

A con­fi­dence in­ter­val cal­cu­lates the prob­a­bil­i­ty — in this case, 95% of the time — that the re­sults of the ex­per­i­ment will fall be­tween two set val­ues. For the non-in­fe­ri­or­i­ty goal, the low­er bound of the 95% con­fi­dence in­ter­val need­ed to be above -10%, which the study did not meet.

Based on these tri­al re­sults, Iterum is mulling its cor­po­rate, strate­gic and fi­nan­cial al­ter­na­tives — in­clud­ing a li­cens­ing, sale or di­vesti­ture of the com­pa­ny’s as­sets or tech­nol­o­gy, a sale of the com­pa­ny, re­struc­tur­ing or seek­ing pro­tec­tion un­der bank­rupt­cy  — com­pa­ny chief Corey Fish­man said.

The shares of the Dublin, Ire­land-based com­pa­ny {ITRM} cratered about 56% to $1.87 in Mon­day morn­ing trad­ing. As of March 31, Iterum had to­tal cash, cash equiv­a­lents and mar­ketable se­cu­ri­ties of $23.3 mil­lion — in its quar­ter­ly re­port pub­lished in mid-May, the com­pa­ny said it had enough cap­i­tal to keep the lights on in­to the sec­ond half of this year.

The re­sults of a third late-stage study test­ing su­lopen­em in pa­tients with un­com­pli­cat­ed UTI is al­so ex­pect­ed soon. “Giv­en the two con­sec­u­tive fail­ures for su­lopen­em, we see in­creas­ing risk in the last read­out in un­com­pli­cat­ed UTI,” SVB Leerink’s Ami Fa­dia wrote in a note.

The in­dus­try play­ers con­tribut­ing to the ar­se­nal of an­timi­cro­bials are fast dwin­dling, and the pipeline for new an­tibi­otics is em­bar­rass­ing­ly sparse, the WHO has warned. Drug­mak­ers are en­ticed by green­er pas­tures, com­pared to the long, ar­du­ous and ex­pen­sive path to an­tibi­ot­ic ap­proval that of­fers lit­tle fi­nan­cial gain as treat­ments are typ­i­cal­ly priced cheap­ly, and of­ten lose po­ten­cy over time as mi­crobes grow re­sis­tant to them.

As it stands, the an­tibi­ot­ic mar­ket is cursed — it har­bors the stink of mul­ti­ple bank­rupt­cies, a dearth of in­no­va­tion and is con­se­quent­ly bare­ly whet­ting the vo­ra­cious ap­petites of ma­jor phar­ma­ceu­ti­cal com­pa­nies and most ven­ture cap­i­tal­ists.

With the Covid-19 cri­sis, an­tibi­ot­ic use is ex­pect­ed to in­crease as doc­tors work on di­min­ish­ing the risk of sec­ondary bac­te­r­i­al in­fec­tions that of­ten emerge in lock­step in hos­pi­tal­ized pa­tients (in­deed emerg­ing da­ta from Chi­na and else­where sug­gest that most hos­pi­tal­ized pa­tients are be­ing giv­en an­tibi­otics pro­phy­lac­ti­cal­ly or as part of treat­ment reg­i­mens). What ef­fect that will have on drug re­sis­tance re­mains to be seen.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

Up­dat­ed: Hit by an­oth­er PhI­II flop, Sanofi culls breast can­cer drug — sound­ing alarm for the class

Sanofi is officially giving up on its oral SERD.

The French drugmaker put out word Wednesday morning that it will discontinue the global development program of amcenestrant, the selective estrogen receptor degrader once billed as a top late-stage prospect. Having already failed a Phase II monotherapy test earlier this year, a combo with the drug also missed the bar in a second trial for breast cancer, triggering the decision to drop the whole program.

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Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

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Kate Haviland, Blueprint Medicines CEO

Blue­print met all its end­points in bid for ex­pand­ed Ay­vak­it la­bel — but stock trends low­er any­way

Blueprint Medicines announced this morning that the second part of its study on Ayvakit in non-advanced systemic mastocytosis (SM) — a rare disease in which a type of white blood cells known as mast cells builds up — met all endpoints, but the biopharma left key questions unanswered.

In 212 patients, with 141 in the treatment arm and 71 in the control arm, patients who got Ayvakit saw an average 15.6-point decrease in their symptom scores compared to a 9.2-point decrease in the placebo arm at 24 weeks. In an extension study, those on Ayvakit saw their symptom scores drop by 20.2 points by week 48.

Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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Marisol Peron, Genmab SVP of communications and corporate affairs

Gen­mab launch­es cor­po­rate cam­paign am­pli­fy­ing its ‘knock your socks off’ an­ti­bod­ies

Genmab often talks about its “knock-your-socks-off” antibodies — and now the term is getting its own logo and corporate campaign.

The teal and purple logo for the acronym KYSO — Genmab pronounces it “ky-so” — debuts on Wednesday and comes on the heels of Genmab’s newly announced 2030 vision. That aspiration aims to expand Genmab’s drug development beyond oncology to include other serious diseases, while also doubling down on its own drug development.

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