Covid-19 roundup: Mer­ck, Ridge­back drop new analy­ses for mol­nupi­ravir; Veru sub­mits EUA for an­tivi­ral treat­ment

As Mer­ck and Ridge­back look to make their Covid an­tivi­ral more com­pet­i­tive to Pfiz­er’s Paxlovid, the com­pa­nies pub­lished ad­di­tion­al da­ta from their Phase III tri­al eval­u­at­ing mol­nupi­ravir, oth­er­wise known as Lagevi­ro.

The tri­al in­ves­ti­gat­ed non-hos­pi­tal­ized adults with mild to mod­er­ate Covid-19 who were at high risk for pro­gress­ing to se­vere dis­ease. Re­sults showed the ex­plorato­ry end­points in­di­cat­ed that a low­er pro­por­tion of Lagevi­ro-treat­ed par­tic­i­pants had an acute care vis­it or a Covid-19-re­lat­ed acute care vis­it ver­sus place­bo-treat­ed par­tic­i­pants.

Da­ta al­so showed that 7.2% of par­tic­i­pants who re­ceived the an­tivi­ral re­port­ed an acute care vis­it through day 29, ver­sus 10.6% of place­bo par­tic­i­pants, with a rel­a­tive risk re­duc­tion of 32.1%.

Mer­ck al­so said few­er peo­ple treat­ed in the MITT pop­u­la­tion re­quired res­pi­ra­to­ry in­ter­ven­tions ver­sus place­bo-treat­ed par­tic­i­pants, with a RRR of 34.3% for all res­pi­ra­to­ry in­ter­ven­tions.

“The analy­ses add to our un­der­stand­ing of the clin­i­cal pro­file of Lagevi­ro and help to re­in­force the im­por­tance of Lagevi­ro as part of the re­sponse to the COVID-19 pan­dem­ic,” said Dean Li, pres­i­dent of Mer­ck Re­search Lab­o­ra­to­ries.

The an­tivi­ral is al­so be­ing eval­u­at­ed for post-ex­po­sure pro­phy­lax­is in an­oth­er Phase III study, look­ing at pre­vent­ing the spread of Covid-19 with­in house­holds.

Ac­cord­ing to Mer­ck, it has 8 mil­lion cours­es of the drug for gov­ern­ments in more than 30 mar­kets across the globe.

How­ev­er, Mer­ck has a lot of catch­ing up to do. In May, it was re­port­ed that Lagevi­ro has strug­gled to make its way out of the in­ven­to­ry clos­et, ac­cord­ing to num­bers post­ed by HHS. On­ly about 20,000 cours­es of the Mer­ck pill were used in the past week, and on­ly about 13% of the to­tal US in­ven­to­ry has been used to date.

This is not the on­ly stum­bling block that the an­tivi­ral has gone up against. In Feb­ru­ary, the FDA re­vised the EUA for mol­nupi­ravir, ex­plain­ing that it should on­ly be used as a last line of de­fense if oth­er treat­ments are avail­able. The EUA, ini­tial­ly is­sued on Dec. 23, 2021, said the pill should be for the treat­ment of mild-to-mod­er­ate Covid-19 in adults with pos­i­tive re­sults of SARS-CoV-2 vi­ral test­ing, and who are at high risk for pro­gress­ing to hos­pi­tal­iza­tion or death — but on­ly when al­ter­na­tive treat­ment op­tions au­tho­rized by FDA are not ac­ces­si­ble or clin­i­cal­ly ap­pro­pri­ate.

Now, Mer­ck is al­so com­pet­ing with Paxlovid at a time when Pfiz­er has dom­i­nat­ed the mar­ket and is con­tin­u­ing to in­vest heav­i­ly in its man­u­fac­tur­ing ca­pac­i­ty, an­nounc­ing plans to in­crease pro­duc­tion at its plant in Kala­ma­zoo, MI on Mon­day.

Veru sub­mits Covid an­tivi­ral to the FDA for a EUA

Af­ter its Phase III was shut down ear­ly in April due to “over­whelm­ing ef­fi­ca­cy,” Veru’s Covid an­tivi­ral has a date with the FDA.

The com­pa­ny has sub­mit­ted a EUA for its sabiz­ab­u­lin oral 9 mg treat­ment of mod­er­ate-to-se­vere hos­pi­tal­ized Covid-19 pa­tients at high risk for de­vel­op­ing acute res­pi­ra­to­ry dis­tress syn­drome, or ARDS.

Veru is bas­ing this sub­mis­sion on its Phase III clin­i­cal tri­al eval­u­at­ing sabiz­ab­u­lin in ap­prox­i­mate­ly 204 hos­pi­tal­ized Covid-19 pa­tients with mod­er­ate-to-se­vere cas­es.

The pri­ma­ry end­point Veru used was the pro­por­tion of deaths by Day 60. The tri­al showed that the drug re­sult­ed in a 55.2% rel­a­tive re­duc­tion in deaths be­fore the IDMC end­ed it due to over­whelm­ing ef­fi­ca­cy.

“Covid-19 new cas­es and hos­pi­tal­iza­tions are on the rise again with a sum­mer and fall-win­ter peaks ex­pect­ed. Un­for­tu­nate­ly, the death rate in hos­pi­tal­ized pa­tients with mod­er­ate to se­vere Covid-19 who are at risk for ARDS re­mains and will con­tin­ue to be un­ac­cept­ably high with the cur­rent stan­dard of care,” said Veru CEO Mitchell Stein­er.

The news has ap­peared to pique the in­ter­est of Veru’s in­vestors as the com­pa­ny has seen its stock $VERU jump 17% in ear­ly Tues­day trad­ing and by 94% in the last month.

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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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.

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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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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Chris Anzalone, Arrowhead CEO

Take­da, Ar­row­head spot­light da­ta from small tri­al show­ing RNAi works in a rare liv­er con­di­tion

Almost two years after Takeda wagered $300 million cash to partner with Arrowhead on an RNAi therapy for a rare disease, the companies are spelling out Phase II data that they believe put them one step closer to their big dreams.

In a small, open label study involving only 16 patients who had liver disease associated with alpha-1 antitrypsin deficiency (AATD), Arrowhead’s candidate — fazirsiran, previously ARO-AAT — spurred substantial reductions in accumulated mutant AAT protein in the liver, a hallmark of the condition. Investigators also tracked improvements in symptoms, with seven out of 12 who received the high, 200 mg dose seeing regression of liver fibrosis.

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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.