Mo­bile apps for IBS? In­de­gene teams with metaMe to launch 'gut-di­rect­ed hyp­nother­a­py' dig­i­tal ther­a­peu­tic

What if in­stead of tak­ing a pill or in­jec­tion, you could down­load an app to help ease the pain of ir­ri­ta­ble bow­el syn­drome?

That’s what the gut-di­rect­ed hyp­nother­a­py be­hind metaMe’s Reg­u­lo­ra pre­scrip­tion dig­i­tal ther­a­peu­tic aims to do. The dig­i­tal app guides users through 7 ses­sions over 12 weeks of vir­tu­al psy­cho­log­i­cal in­ter­ven­tions. It’s not un­proven sci­ence — in-per­son cog­ni­tive-be­hav­ioral ther­a­pies, hyp­nother­a­py and mind­ful­ness-based ther­a­pies have proven ef­fec­tive in treat­ing IBS and IBD.

But will that ef­fec­tive­ness trans­late to a dig­i­tal ther­a­peu­tic? With FDA au­tho­riza­tion and study da­ta, along with go-to-mar­ket part­ner In­de­gene, metaMe is look­ing to find out when the app launch­es in the third quar­ter.

As co-com­mer­cial­iza­tion part­ner, In­de­gene is not on­ly work­ing on pay­er cov­er­age, along with out­reach to health­care providers and prep­ping Reg­u­lo­ra mar­ket­ing for con­sumers but al­so bas­ing its pay­ment on out­comes. In­de­gene and metaMe’s co-com­mer­cial­iza­tion mod­el means the for­mer’s ef­forts for the IBS dig­i­tal ther­a­peu­tic will be com­pen­sat­ed based on its suc­cess.

Out­come-based mod­els are be­com­ing more com­mon in phar­ma drug com­mer­cial­iza­tion — when a drug­mak­er’s pay­out is de­pen­dent on the ef­fec­tive­ness of the treat­ment – but it’s less com­mon in com­mer­cial­iza­tion and mar­ket­ing.

Marut Se­tia

“We work a whole lot of young com­pa­nies, if you will, and we work with them on a mod­el that is more suit­able for them, with risks and re­wards shared with In­de­gene,” Marut Se­tia, SVP of med­ical tech­nol­o­gy for In­de­gene, said. “…We’re mov­ing away from a tra­di­tion­al chan­nel where you say ‘I did 5 cam­paigns for you, so you owe me $500,000.’ It’s not the same any­more. The ques­tion is how many leads are you able to gen­er­ate, how many im­pres­sions did we get for you, how many sales and how many pre­scribers?”

With Reg­u­lo­ra FDA-cleared and ready for physi­cian pre­scrib­ing at launch, In­de­gene is fo­cus­ing first on pay­ers fol­lowed by HCP ed­u­ca­tion. Pre­scrip­tion dig­i­tal ther­a­peu­tics are more com­mon in men­tal health, sub­stance abuse and pain man­age­ment cat­e­gories, but there aren’t many in IBS. The Dig­i­tal Ther­a­peu­tics Al­liance lists 20 ex­am­ple dig­i­tal ther­a­peu­tics on its web­site, but none that treat IBS. There are a few oth­ers though in­clud­ing Ma­hana Ther­a­peu­tics’ Par­al­lel app au­tho­rized in 2020.

Se­tia said Reg­u­lo­ra has the proven da­ta to back its ef­fec­tive­ness, so “now it’s a ques­tion of com­mu­ni­ca­tion and tak­ing that ev­i­dence to the skep­tics through the right chan­nels.”

HCP and even­tu­al pa­tient mar­ket­ing will be based on ed­u­ca­tion – ex­plain­ing the new­er con­cept of us­ing dig­i­tal ther­a­peu­tics for IBS and, specif­i­cal­ly for HCPs, show­ing clin­i­cal ev­i­dence and tar­get­ing and pri­or­i­tiz­ing the right clin­i­cians.

Pa­tient ed­u­ca­tion will in­clude talk­ing to ad­vo­ca­cy groups ad­dress­ing ques­tions and defin­ing the ben­e­fits, Se­tia said.

De­vel­op­ment of dig­i­tal ther­a­peu­tics or DTx is ac­cel­er­at­ing, thanks in part to the Covid-19 pan­dem­ic. A re­cent study in PLOS found 63 al­ready ap­proved, but a whop­ping 150 FDA-reg­u­lat­ed DTx are ex­pect­ing clin­i­cal tri­al re­sults this year.

Still, ed­u­ca­tion, as the mar­ket de­vel­ops, will be nec­es­sary. While most US adults gave pos­i­tive marks to dig­i­tal health tools as con­ve­nient, safe and ac­cu­rate, about one-third al­so found them dif­fi­cult to use, scary or con­fus­ing, ac­cord­ing to a Morn­ing Call sur­vey last year.

How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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Scoop: Roche scraps one of two schiz­o­phre­nia PhII tri­als due to missed pri­ma­ry end­point

Roche has terminated one of two Phase II trials testing its drug ralmitaront in patients with schizophrenia, the Big Pharma confirmed to Endpoints News.

The study was terminated last month, according to a June 22 update to the registry on Begun in September 2020, the trial was looking at ralmitaront in patients with acute schizophrenia. The trial enrolled 286 patients out of an originally planned 308.

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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Matt Gline, Roivant CEO (John Sciulli/Getty Images for GLG)

Roivant chops sick­le cell gene ther­a­py, der­ma­tol­ogy drugs to fo­cus on 'high­er val­ue pro­ject­s'

Roivant is sweeping a suite of drugs, including a gene therapy for sickle cell disease already in the clinic, out of its pipeline.

Six programs from four of its “vants” are being wound down as part of “a company-wide cost optimization and pipeline reprioritization initiative to reduce our expected operating expenses and prioritize our capital resources.”

When reached by Endpoints News, a spokesperson said, “We don’t anticipate a material reduction in headcount but we will likely reassign some folks to higher value projects as part of winding down specific programs.”

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Laurence Reid, Decibel CEO

Still in pre­clin­i­cal test­ing for ear gene ther­a­pies, Deci­bel touts small snap­shot of chemo-in­duced hear­ing loss drug

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.