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.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Am­gen, years be­hind ri­vals, says PhI obe­si­ty drug shows dura­bil­i­ty signs

While NBC ran “The Biggest Loser” for 17 seasons, deemed toxic by critics for the reality show’s punishing exercise and diet upheavals, researchers in pharmaceutical labs have been attempting to create prescription drugs that induce weight loss — and one pharma betting it can require less frequent dosing is out with a new crop of data.

Amgen was relatively late to the game compared to its approved competitor Novo Nordisk and green light-approaching rival Eli Lilly. But early data suggested Amgen’s AMG 133 led to a 14.5% weight reduction in the first few months of dosing, buoying shares earlier this fall, and now the California pharma is out with its first batch of durability data showing that figure fell slightly to 11.2% about 150 days after the last dose. Amgen presented at the 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease on Saturday afternoon.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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US month­ly costs for biosim­i­lars 'sub­stan­tial­ly high­er' than Ger­many or Switzer­land, JA­MA re­search finds

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

Kirk Myers is shown in a still image from a new film series showcasing the efforts of HIV advocates funded by Gilead.

Gilead spot­lights HIV projects and the com­mu­ni­ty lead­ers dri­ving them in new mi­ni-doc­u­men­tary films

Gilead is going behind the scenes of some of the HIV initiatives it funds through grants in a new film series narrated by the people helming the projects.

The first four films and leaders come from across the US — Arianna Lint in Florida and Puerto Rico, Cleve Jones in San Francisco, June Gipson in Mississippi and Kirk Myers in Texas. Their HIV-focused efforts range from addressing unmet needs of the transgender community to delivering social services and high-quality health care in underserved communities.

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EMA pulls an opi­oid from the 1950s used to treat dry cough

The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.

The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs) used (with an adjusted OR of 4.2, and a 95% confidence interval of 2.5 to 6.9).

John Evans, Beam Therapeutics CEO

Beam's base-edit­ed al­lo­gene­ic CAR-T gets FDA go-ahead af­ter four-month wait

The FDA wanted more information on four key areas before it would let Beam Therapeutics proceed with human testing for a cell therapy in a certain type of leukemia. It appears the biotech has answered the agency’s queries.

The US regulator cleared the base-edited, off-the-shelf CAR-T, Beam said Friday morning, lifting a hold from this summer. More details on specific next steps for the Phase I will come out next year, the Boston-area biotech said.

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