Covid-19 roundup: NRx's med gets axed from NIH tri­al over fu­til­i­ty; A new drug for the pan­dem­ic en­ters the clin­ic

There were more deaths in the treat­ment group than place­bo co­hort in an NIH study of NRx Phar­ma­ceu­ti­cals’ al­ready-re­ject­ed Covid-19 drug, and the da­ta safe­ty board rec­om­mend­ed stop­ping the tri­al.

The board said the study of Zye­sa­mi or avip­tadil, the last re­main­ing in­ves­ti­ga­tion­al med in the NIH’s AC­TIV-3b tri­al of crit­i­cal Covid-19 pa­tients, should end be­cause of fu­til­i­ty. The pri­ma­ry goal of 90 day 6-cat­e­go­ry or­di­nal score was “not sup­port­ive” and the mor­tal­i­ty sec­ondary end­point was al­so not good enough to push the drug fur­ther.

In the treat­ment arm, the mor­tal­i­ty was 37% com­pared to 36% in the place­bo group.

Across the 460 pa­tients, there were no safe­ty con­cerns and the known side ef­fects of the drug, in­clud­ing di­ar­rhea and hy­poten­sion, “were man­aged well with the pro­to­cols in place,” the com­pa­ny said.

“We will con­tin­ue to work close­ly with [NIH and tri­al lead­er­ship] to bet­ter un­der­stand the da­ta over the com­ing months. This will al­so en­able us to eval­u­ate the op­tions for Zye­sa­mi in pro­tect­ing the lung in oth­er res­pi­ra­to­ry dis­or­ders, as well as its po­ten­tial in oth­er ther­a­peu­tic ar­eas,” said in­ter­im CEO Robert Besthof. The for­mer NRx CCO be­came in­ter­im chief ex­ec­u­tive af­ter Jonathan Javitt re­tired in March.

The FDA had al­ready re­ject­ed an EUA for the drug last No­vem­ber, but the com­pa­ny has since sub­mit­ted a new emer­gency re­quest for pa­tients who are at “im­me­di­ate risk of death from res­pi­ra­to­ry fail­ure.”

The tri­al news sent NRx shares $NRXP in a 37% nose­dive be­fore Thurs­day’s open­ing bell. The biotech al­so dis­closed in an SEC fil­ing yes­ter­day that its chief cor­po­rate of­fi­cer Alessan­dra Daigneault will re­sign on Ju­ly 18, as will CFO Ira Strass­berg.

An­oth­er biotech en­ters the Covid-19 clin­i­cal de­vel­op­ment are­na

Mol­e­culin has be­gun test­ing its in­ves­ti­ga­tion­al Covid-19 med in the sin­gle-as­cend­ing dose por­tion of its Phase I study. The oral­ly de­liv­ered drug will move to a mul­ti­ple-as­cend­ing dose phase once three dos­ing co­horts have been found to be safe, the com­pa­ny said Thurs­day.

The on­col­o­gy and virus-fo­cused biotech is test­ing WP1122, a me­tab­o­lism/gly­co­sy­la­tion in­hibitor that is a re­vised ver­sion of a glu­cose de­coy called 2-de­oxy-D-glu­cose.

The 80-pa­tient tri­al could serve as a back­bone for WP1122’s po­ten­tial in treat­ing can­cers as well, the com­pa­ny said.

“Im­por­tant­ly, es­tab­lish­ing safe­ty and an MTD in this study not on­ly sets the stage for fur­ther an­tivi­ral de­vel­op­ment, but it al­so fa­cil­i­tates po­ten­tial Phase 2 clin­i­cal tri­als for can­cer in­di­ca­tions,” CEO and chair Wal­ter Klemp said in a press re­lease.

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.

Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP Images)

Up­dat­ing the Covid-19 vac­cine: FDA of­fers a qual­i­fied thumbs-up ahead of ad­comm

The FDA’s adcomm of outside vaccine experts will meet tomorrow to discuss how to protect the US from a likely coming wave of Omicron cases in the fall and winter, and whether to deploy vaccines that specifically target the Omicron variant.

While the data so far are limited, the FDA sounded an upbeat tone in the briefing documents on Pfizer/BioNTech’s candidates, released this weekend ahead of the VRBPAC meeting.

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.