Rin­voq nabs new ap­proval in sec­ond-line UC; Sen­so­ri­on says its failed drug now works in sub­set analy­sis

Ab­b­Vie’s Rin­voq racked up an­oth­er ap­proval late Wednes­day af­ter­noon.

The drug is now OK’d in adults with mod­er­ate­ly to se­vere­ly ac­tive ul­cer­a­tive col­i­tis who have had an in­ad­e­quate re­sponse or in­tol­er­ance to one or more TNF block­ers, Ab­b­Vie said in a press re­lease. It’s the first ap­proval for the drug in gas­troen­terol­o­gy, the com­pa­ny added, with da­ta stem­ming from three Phase III stud­ies.

“There re­mains an un­met need for pa­tients with mod­er­ate­ly to se­vere­ly ac­tive UC, who suf­fer from de­bil­i­tat­ing symp­toms that are of­ten un­pre­dictable and bur­den­some,” said Thomas Hud­son, Ab­b­Vie CSO. “With the ap­proval of Rin­voq as a new treat­ment op­tion, Ab­b­Vie con­tin­ues our lead­er­ship in ad­vanc­ing re­search that can help im­pact the lives of peo­ple liv­ing with ul­cer­a­tive col­i­tis.”

Wednes­day’s ap­proval comes a few months af­ter the agency slapped a new warn­ing on the drug af­ter Pfiz­er’s Xel­janz saw in­creased side ef­fects, rel­e­gat­ing the drug to sec­ond-line use in rheuma­toid arthri­tis. The warn­ing came amid the back­drop of a larg­er safe­ty saga play­ing out for the en­tire JAK class of drugs. — Max Gel­man

Sen­so­ri­on claims vic­to­ry on ex­plorato­ry end­points af­ter PhII fail­ure

French biotech Sen­so­ri­on got ham­mered back in Jan­u­ary af­ter its on­ly clin­i­cal stage drug failed to meet the pri­ma­ry end­point in a Phase II study — los­ing 40% of its share val­ue af­ter the news was an­nounced about its lead drug SENS-401, a treat­ment of sud­den sen­sorineur­al hear­ing loss (SSNHL).

To­day, the biotech says it has some more da­ta. And this time, it says that they found some sta­tis­ti­cal­ly sig­nif­i­cant treat­ment ef­fects in spe­cif­ic pop­u­la­tions af­ter they re­viewed ex­plorato­ry end­points. Those in­clude pa­tients suf­fer­ing from pro­found hear­ing loss treat­ed with cor­ti­cos­teroids see­ing an im­prove­ment of 19-26 dB from base­line com­pared to place­bo.

Ex­plorato­ry end­points, how­ev­er, are gen­er­al­ly con­sid­ered far less con­clu­sive than end­points that were set ahead of time, and are gen­er­al­ly used on­ly to de­sign fu­ture tri­als, rather than to of­fer de­fin­i­tive an­swers on ef­fi­ca­cy.

In­vestors re­spond­ed fa­vor­ably to the new de­vel­op­ment, ini­tial­ly sky­rock­et­ing the stock up over 43% be­fore sta­bi­liz­ing at around a 20% in­crease.

The drug is still in play in a col­lab­o­ra­tion on hear­ing preser­va­tion fol­low­ing cochlear im­plants. Sen­so­ri­on and part­ner Cochlear Lim­it­ed are mov­ing for­ward with a tri­al and have sub­mit­ted tri­al de­sign plans to reg­u­la­tors in Aus­tralia and France. — Paul Schloess­er

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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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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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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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.

Ben Zimmer, Priovant CEO

Roivant un­veils lat­est spin­out as Pfiz­er en­trusts JAK1/TYK2 to Pri­o­vant

In November, Pfizer disclosed it’s spun out the Phase II dual JAK1/TYK2 inhibitor to a startup formed in collaboration with an unnamed, experienced partner.

We now know who the partner is. And as Pfizer and Roivant officially take the wraps off Priovant Therapeutics, the companies reveal that they have started two registrational trials of the drug, brepocitinib, as part of a broader plan to develop a big, first-in-class franchise spanning multiple orphan and specialty autoimmune diseases.

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.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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