Covid-19 roundup: Synair­gen turns to post-hoc analy­ses af­ter failed drug tri­al; EU ter­mi­nates Val­ne­va vac­cine con­tract

Af­ter halt­ing en­roll­ment in an NIH-led Phase II/III study, and fail­ing an ear­li­er Phase III tri­al, UK-based Synair­gen’s Covid-19 drug did show some promise in some se­lect sub­groups, the com­pa­ny said in its pre­sen­ta­tion of a post-hoc analy­sis on Mon­day at a con­fer­ence in San Fran­cis­co.

Post-hoc analy­ses of the Phase III SPRINT­ER tri­al, which failed to hit its pri­ma­ry end­points, showed an “en­cour­ag­ing sig­nal in re­duc­tion in the rel­a­tive risk (RRR) of pro­gres­sion to se­vere dis­ease or death with­in 35 days (25.7% re­duc­tion in the In­ten­tion-to-Treat pop­u­la­tion and 36.3% re­duc­tion in the Per Pro­to­col pop­u­la­tion).”

The com­pa­ny al­so tried to high­light “stronger treat­ment ef­fects with SNG001 in these high-risk pa­tient sub-groups, with the strongest ef­fect ob­served in those who had clin­i­cal signs of com­pro­mised res­pi­ra­to­ry func­tion.”

But the pre­sen­ta­tion may be a last-ditch ef­fort to show in­vestors some­thing en­cour­ag­ing, even as the com­pa­ny has ac­knowl­edged it’s still look­ing to con­firm those post-hoc analy­ses in a larg­er plat­form tri­al.

EU drops Val­ne­va Covid-19 vac­cine con­tract

Val­ne­va’s stock price dropped by more than 20% ear­ly Mon­day as the com­pa­ny dis­closed that the EU is no longer in­ter­est­ed in its Covid-19 vac­cine.

As the com­pa­ny’s con­tract with the EU out­lined, the EU has the right to trig­ger its in­tent to ter­mi­nate the ad­vance pur­chase agree­ment for Val­ne­va’s in­ac­ti­vat­ed whole-virus Covid-19 vac­cine can­di­date as the vac­cine has not yet been au­tho­rized. Val­ne­va has 30 days from last Fri­day to ob­tain a mar­ket­ing au­tho­riza­tion or pro­pose an ac­cept­able re­me­di­a­tion plan.

The com­pa­ny an­nounced late last month that it re­ceived fur­ther ques­tions from the Eu­ro­pean Med­i­cines Agency’s Com­mit­tee for Med­i­c­i­nal Prod­ucts for Hu­man Use, which the com­pa­ny re­spond­ed to on May 2. If CHMP finds Val­ne­va’s re­spons­es ac­cept­able, the com­pa­ny said it would ex­pect to re­ceive a pos­i­tive CHMP opin­ion next month, at the lat­est.

In the UK, how­ev­er, Val­ne­va re­cent­ly won a con­di­tion­al mar­ket­ing au­tho­riza­tion for the pri­ma­ry im­mu­niza­tion of adults 18 to 50 years of age.

Re­port finds sig­nif­i­cant Covid-19 drug re­search waste

Most clin­i­cal tri­als of po­ten­tial Covid-19 drugs served as noth­ing more than re­search waste, de­lay­ing the iden­ti­fi­ca­tion of ef­fec­tive treat­ments, a new re­port from Transparimed and Health Ac­tion In­ter­na­tion­al finds.

The re­port re­views the in­tegri­ty of clin­i­cal tri­als for Covid vac­cines, re­pur­posed drugs and non-phar­ma in­ter­ven­tions, high­light­ing the suc­cess of tri­als like the UK-based RE­COV­ERY tri­al, which de­liv­ered strong ev­i­dence on the ef­fi­ca­cy (or lack there­of) of five wide­ly in­ves­ti­gat­ed re­pur­posed drugs (dex­am­etha­sone, hy­drox­y­chloro­quine, azithromycin, lopinavir and ri­ton­avir), and which the re­port said prob­a­bly saved hun­dreds of thou­sands of lives world­wide – and made hun­dreds of small­er tri­als in oth­er coun­tries clin­i­cal­ly ir­rel­e­vant.

On the neg­a­tive end, the re­port points to small tri­als run in Spain, the US, and Chi­na.

“Spain pro­vides a clear ex­am­ple of the un­co­or­di­nat­ed pro­lif­er­a­tion of fu­tile Covid-19 tri­als,” the re­port says. “In ad­di­tion, the wide­spread hap­haz­ard ad­min­is­tra­tion to US pa­tients of ex­per­i­men­tal treat­ments (in­clud­ing HCQ and con­va­les­cent plas­ma) in non-tri­al set­tings re­duced the pool of pa­tients el­i­gi­ble for par­tic­i­pa­tion in tri­als. Re­searchers in Chi­na ini­tial­ly reg­is­tered a large num­ber of tri­als (ap­par­ent­ly in an un­co­or­di­nat­ed man­ner) but these nev­er gained trac­tion as in­fec­tion rates there rapid­ly dropped to vir­tu­al­ly ze­ro.”

The re­port echoes sim­i­lar sen­ti­ments ex­pressed by FDA prin­ci­pal deputy Janet Wood­cock and for­mer NIH di­rec­tor Fran­cis Collins, both of whom lament­ed the US tri­al land­scape for Covid drugs.

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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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.

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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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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A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

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.

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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