Months af­ter flop­ping in an NIH-spon­sored study, Brii Bio­sciences’ Covid-19 an­ti­body com­bo has re­deemed it­self in a sec­ond tri­al.

The biotech says its an­ti­bod­ies — which had hailed from Bei­jing’s Ts­inghua Uni­ver­si­ty and Shen­zhen Third Peo­ple’s Hos­pi­tal — dra­mat­i­cal­ly im­proved pa­tients’ odds of get­ting hos­pi­tal­ized or dy­ing over place­bo, notch­ing a sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion of 78%. That trans­lates to a risk ra­tio of 0.22 (95% con­fi­dence in­ter­val: 0.05, 0.86; p<.00001).

Specif­i­cal­ly, when in­ves­ti­ga­tors did a par­tial fol­lowup on the 837 non-hos­pi­tal­ized pa­tients en­rolled in this arm of AC­TIV-2 tri­al at an in­ter­im analy­sis, they found:

[A] re­duc­tion in both hos­pi­tal­iza­tions 12 (ac­tive) vs 45 (place­bo) and deaths 1 (ac­tive) vs 9 (place­bo), was ob­served. Ad­di­tion­al sub­group analy­sis may fur­ther de­lin­eate the clin­i­cal ben­e­fits of ear­ly (≤5 days) ver­sus late (6-10 days) treat­ment with BRII-196/BRII-198 fol­low­ing symp­tom on­set, pro­vid­ing unique in­sight to in­form re­al-world treat­ment de­ci­sions.

The find­ings fit right with da­ta on oth­er an­ti­body cock­tails di­rect­ed against Covid-19. From Eli Lil­ly and Re­gen­eron to Glax­o­SmithK­line/Vir, an­ti­bod­ies have ap­peared much more ef­fec­tive when they’re de­ployed ear­ly. Once pa­tients are hos­pi­tal­ized, the an­ti­bod­ies tend not to help — with Re­gen­eron be­ing the on­ly ex­cep­tion, show­ing that its cock­tail could re­duce death for a sub­group of par­tic­u­lar­ly vul­ner­a­ble hos­pi­tal­ized pa­tients.

So it was lit­tle sur­prise when Brii, too, failed to show a trend to­ward clin­i­cal ben­e­fit among hos­pi­tal­ized pa­tients in the NIH’s AC­TIV-3 tri­al. As such, the NIH shut down the study sub­group eval­u­at­ing the pro­gram and halt­ed en­roll­ment ear­ly.

In AC­TIV-2, the op­po­site hap­pened: The da­ta safe­ty mon­i­tor­ing board sanc­tioned re­leas­ing the re­sults ear­ly af­ter re­view­ing around 69% of tri­al par­tic­i­pants on the com­bined pri­ma­ry end­point of hos­pi­tal­iza­tions and death.

On the safe­ty front, Brii not­ed that the BRII196/BRII-198 arm ac­tu­al­ly saw few­er Grade 3 or high­er ad­verse events than the place­bo co­hort in the 28 days fol­low­ing treat­ment (3.8% ver­sus 13.4%). No drug-re­lat­ed se­ri­ous side ef­fects, in­fu­sion re­ac­tions or deaths were ob­served in ei­ther arm.

Pa­tients from the US, Brazil, South Africa, Mex­i­co, Ar­genti­na and the Philip­pines were en­rolled in the tri­al be­tween Jan­u­ary and Ju­ly of 2021.

“In re­sponse to the re­cent emer­gence of COVID-19 cas­es in Chi­na, in­clud­ing cas­es caused by the Delta vari­ant, Brii Bio­sciences has co­op­er­at­ed with gov­ern­men­tal agen­cies and hos­pi­tals in Chi­na to sup­ply BRII-196/BRII-198 for emer­gency clin­i­cal use in Guangzhou, Shen­zhen, Ruili, Kun­ming, Nan­jing, Yangzhou, Zhangji­a­jie and Zhengzhou,” the com­pa­ny, which re­cent­ly got list­ed on the Hong Kong stock ex­change fol­low­ing a $320 mil­lion IPO raise, added in a state­ment.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.