Paratek shares shoot up on a pos­i­tive PhI­II and a slow-mo shot at FDA/EMA OK for its an­tibi­ot­ic

Chem­i­cal Struc­ture

Shares of Paratek shot up 30% $PRTK in af­ter-mar­ket trad­ing on Mon­day as in­vestors re­act­ed to the Boston biotech’s procla­ma­tion of a clean sweep for its piv­otal test of its new an­tibi­ot­ic omada­cy­cline. Ex­ecs said that their broad spec­trum an­tibi­ot­ic hit its pri­ma­ry and sec­ondary end­points for the FDA as well as the co-pri­maries need­ed for the EMA in their sec­ond pos­i­tive late-stage tri­al.

Re­searchers went look­ing for ev­i­dence that omada­cy­cline matched up with mox­i­floxacin in the treat­ment of pa­tients with com­mu­ni­ty-ac­quired bac­te­r­i­al pneu­mo­nia (CABP). And that’s what they got, with ear­ly clin­i­cal re­sponse rates scor­ing 81.1 % and 82.7% in new and old an­tibi­otics.

Evan Loh, Paratek

The co-pri­ma­ry end­points for the EMA were non-in­fe­ri­or­i­ty in the in­tent-to-treat group and the evalu­able CABP pop­u­la­tions in those pa­tients with Pneu­mo­nia Sever­i­ty In­dex (PORT) III and IV at the post treat­ment eval­u­a­tion time point. And the safe­ty pro­file looked com­pa­ra­ble as well. Fol­low­ing a suc­cess­ful Phase III for skin in­fec­tions, Paratek has the two pos­i­tive stud­ies it needs to sat­is­fy the FDA.

This an­tibi­ot­ic is start­ed as an IV and doc­tors can then switch to an oral ver­sion.

An­tibi­ot­ic de­vel­op­ment, though, can be a slow process and Paratek says it has around a year left on the clock be­fore it files for an ap­proval. The ap­pli­ca­tions may ar­rive at the FDA “as ear­ly as” Q1 2018, the com­pa­ny says, with the EMA on the re­ceiv­ing end some­time af­ter that.

With ap­pli­ca­tions that late, don’t look for any po­ten­tial ap­provals be­fore late 2018.

While the threat of drug re­sis­tant bac­te­ria has in­creased the need for new an­tibi­otics, Paratek is one of on­ly a hand­ful of biotechs which dived in­to this area. There are a num­ber of cheap, gener­ic an­tibi­otics avail­able for front­line use. And any new an­tibi­ot­ic is go­ing to face an up­hill bat­tle gain­ing trac­tion in this mar­ket.

Leerink not­ed re­cent­ly:

For 2025 we cur­rent­ly mod­el ~$230MM and ~$330MM op­por­tu­ni­ties in skin and pneu­mo­nia and al­so in­clude a small amount of risk-ad­just­ed (at 15%) cred­it for uri­nary tract in­fec­tion.

Paratek and its US part­ner Al­ler­gan $AGN post­ed pos­i­tive da­ta from two Phase III stud­ies of sara­cy­cline for ac­ne. But Al­ler­gan con­trols the bulk of the rev­enue, and the com­pa­ny ex­pects peak sales to tap out around $275 mil­lion. That FDA ap­pli­ca­tion will ar­rive soon­er, though, with reg­u­la­tors get­ting the pack­age in the sec­ond half of this year.

“We now have ex­pe­ri­ence with omada­cy­cline in more than 1,500 pa­tients in our clin­i­cal pro­gram and we are very pleased with the safe­ty, tol­er­a­bil­i­ty, and ef­fi­ca­cy pro­file that we have seen to date,” said Evan Loh, pres­i­dent and CMO at Paratek.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Lisa M. DeAngelis, MSKCC

MSK picks brain can­cer ex­pert Lisa DeAn­ge­lis as its next CMO — fol­low­ing José Basel­ga’s con­tro­ver­sial ex­it

It’s official. Memorial Sloan Kettering has picked a brain cancer expert as its new physician-in-chief and CMO, replacing José Baselga, who left under a cloud after being singled out by The New York Times and ProPublica for failing to properly air his lucrative industry ties.

His replacement, who now will be in charge of MSK’s cutting-edge research work as well as the cancer care delivered by hundreds of practitioners, is Lisa M. DeAngelis. DeAngelis had been chair of the neurology department and co-founder of MSK’s brain tumor center and was moved in to the acting CMO role in the wake of Baselga’s departure.

Penn team adapts CAR-T tech, reengi­neer­ing mouse cells to treat car­diac fi­bro­sis

After establishing itself as one of the pioneer research centers in the world for CAR-T cancer therapies, creating new attack vehicles to eradicate cancer cells, a team at Penn Medicine has begun the tricky transition of using the basic technology for heart repair work.

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Tal Zaks. Moderna

The mR­NA uni­corn Mod­er­na has more ear­ly-stage hu­man da­ta it wants to show off — reach­ing new peaks in prov­ing the po­ten­tial

The whole messenger RNA field has attracted billions of dollars in public and private investor cash gambled on the prospect of getting in on the ground floor. And this morning Boston-based Moderna, one of the leaders in the field, wants to show off a few more of the cards it has to play to prove to you that they’re really in the game.

The whole hand, of course, has yet to be dealt. And there’s no telling who gets to walk with a share of the pot. But any cards on display at this point — especially after being accused of keeping its deck under lock and key — will attract plenty of attention from some very wary, and wired, observers.

“In terms of the complexity and unmet need,” says Tal Zaks, the chief medical officer, “this is peak for what we’ve accomplished.”

Moderna has two Phase I studies it wants to talk about now.

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It's not per­fect, but it's a good start: FDA pan­elists large­ly en­dorse Aim­mune's peanut al­ler­gy ther­a­py

Two days after a fairly benign review from FDA staff, an independent panel of experts largely endorsed the efficacy and safety of Aimmune’s peanut allergy therapy, laying the groundwork for approval with a risk evaluation and mitigation strategy (REMS).

Traditionally, peanut allergies are managed by avoidance, but the threat of accidental exposure cannot be nullified. Some allergists have devised a way to dose patients off-label with peanut protein derived from supermarket products to wean them off their allergies. But the idea behind Aimmune’s product was to standardize the peanut protein, and track the process of desensitization — so when accidental exposure in the real world invariably occurs, patients are less likely to experience a life-threatening allergic reaction.

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Rit­ter bombs fi­nal PhI­II for sole lac­tose in­tol­er­ance drug — shares plum­met

More than two years ago Ritter Pharmaceuticals managed to find enough silver lining in its Phase IIb/III study — after missing the top-line mark — to propel its lactose intolerance toward a confirmatory trial. But as it turned out, the enthusiasm only set the biotech and its investors up to be sorely disappointed.

This time around there’s little left to salvage. Not only did RP-G28 fail to beat placebo in reducing lactose intolerance symptoms, patients in the treatment group actually averaged a smaller improvement. On a composite score measuring symptoms like abdominal pain, cramping, bloating and gas, patients given the drug had a mean reduction of 3.159 while the placebo cohort saw a 3.420 drop on average (one-sided p-value = 0.0106).

Ear­ly snap­shot of Ad­verum's eye gene ther­a­py sparks con­cern about vi­sion loss

An early-stage update on Adverum Biotechnologies’ intravitreal gene therapy has triggered investor concern, after patients with wet age-related macular degeneration (AMD) saw their vision deteriorate, despite signs that the treatment is improving retinal anatomy.

Adverum, on Wednesday, unveiled 24-week data from the OPTIC trial of its experimental therapy, ADVM-022, in six patients who have been administered with one dose of the therapy. On average, patients in the trial had severe disease with an average of 6.2 anti-VEGF injections in the eight months prior to screening and an average annualized injection frequency of 9.3 injections.

Alex Ar­faei trades his an­a­lyst's post for a new role as biotech VC; Sanofi vet heads to Vi­for

Too often, Alex Arfaei arrived too late. 

An analyst at BMO Capital Markets, he’d meet with biotech or pharmaceutical heads for their IPO or secondary funding and his brain, trained on a biology degree and six years at Merck and Endo, would spring with questions: Why this biomarker? Why this design? Why not this endpoint? Not that he could do anything about it. These execs were coming for clinical money; their decisions had been made and finalized long ago.

Arde­lyx bags its first FDA OK for IBS, set­ting up a show­down with Al­ler­gan, Iron­wood

In the first of what it hopes will be a couple of major regulatory milestones for its new drug, Ardelyx has bagged an FDA approval to market Ibsrela (tenapanor) for irritable bowel syndrome.

The drug’s first application will be for IBS with constipation (IBS-C), inhibiting sodium-hydrogen exchanger NHE3 in the GI tract in such a way as to increase bowel movements and decrease abdominal pain. This comes on the heels of two successful Phase III trials.