A lit­tle over a year af­ter flop­ping out of the chron­ic cough game and leav­ing Mer­ck as the sole play­er, Bel­lus Health is say­ing it’s back in con­tention.

The Cana­di­an biotech tout­ed a Phase IIb in­ter­im analy­sis Mon­day morn­ing it de­scribed as pos­i­tive, say­ing that “at least one dose” of its ex­per­i­men­tal chron­ic cough drug post­ed a clin­i­cal­ly mean­ing­ful re­duc­tion in place­bo-ad­just­ed 24-hour cough fre­quen­cy af­ter four weeks. It’s a re­sult that comes rough­ly 15 months af­ter an­oth­er Phase II tri­al re­port­ed a miss on all four dos­es, send­ing shares $BLU down more than 75% at the time.

Bel­lus, how­ev­er, re­port­ed ex­act­ly ze­ro da­ta, and the press re­lease an­nounc­ing the re­sults was vague. The biotech said on­ly that an in­de­pen­dent team re­port­ed the re­sults met a “pre­de­fined strin­gent prob­a­bil­i­ty thresh­old for clin­i­cal ef­fi­ca­cy.”

“We be­lieve the en­cour­ag­ing SOOTHE Phase IIb tri­al in­ter­im analy­sis will en­able us to ac­cel­er­ate the plan­ning for our Phase III pro­gram while await­ing SOOTHE fi­nal re­sults,” CEO Rober­to Belli­ni said in a state­ment. “With tri­al en­roll­ment pro­gress­ing as planned, we an­tic­i­pate an­nounc­ing topline da­ta in the fourth quar­ter of 2021.”

It wasn’t im­me­di­ate­ly clear when Bel­lus would launch the Phase III, or which of the dos­ing lev­els passed the Phase IIb test. In an emailed state­ment to End­points News, the com­pa­ny said it has not put out guid­ance for the Phase III study and will not be dis­clos­ing the dos­ing lev­el that hit the pri­ma­ry un­til the topline da­ta are re­leased.

“All we can dis­close at this time is the fact that at least one dose (and up to 3 dos­es) has met” the ap­pro­pri­ate re­duc­tion lev­els, a spokesper­son said in an email.

In­vestors, though, ap­peared to cheer the news — at least ear­ly on. In the im­me­di­ate wake of the an­nounce­ment Bel­lus stock moved up more than 35% but lev­eled off to flat af­ter Mon­day’s open­ing bell.

Bel­lus’ new da­ta come from a study that looked at a dif­fer­ent pa­tient pop­u­la­tion than its pre­vi­ous fail­ure. The tri­al looked at pa­tients with at least 25 coughs per hour, a cri­te­ri­on that was not in­clud­ed in the old­er study but was an area where some da­ta had sug­gest­ed the pro­gram might be more ef­fec­tive.

Re­searchers re­cruit­ed 300 pa­tients and ran­dom­ized them in­to three treat­ment arms — Bel­lus dropped the third-high­est dose, out of the orig­i­nal four — and a place­bo group, mak­ing this study about five times larg­er than the last. The com­pa­ny al­so made sure to spread out the num­ber of se­vere cough pa­tients, or those de­fined as ex­pe­ri­enc­ing at least 45 coughs per hour, even­ly across the four groups.

In­vestors will have a bet­ter idea of just how good the new da­ta are once Bel­lus reads out topline da­ta lat­er this year, but re­sults from a sub­group in the old­er tri­al may give some in­sight. Look­ing at 31 pa­tients with a cough fre­quen­cy at or above the me­di­an of 32.4 coughs per hour, the Bel­lus pro­gram re­duced awake cough fre­quen­cy by 28% to 32% across all four dos­es.

Though the end­points were slight­ly dif­fer­ent, fig­ures any­where close to that in the new study would come in high­er than Mer­ck’s gefapix­ant pro­gram, which is cur­rent­ly un­der FDA re­view. Cross-tri­al com­par­isons are al­ways a risky busi­ness, but Mer­ck reg­is­tered on­ly an 18.5% es­ti­mat­ed rel­a­tive risk re­duc­tion in 24-hour cough fre­quen­cy with a p-val­ue com­ing in at p=0.041.

This wouldn’t prove such a high bar for Bel­lus to cross. It’s al­so worth not­ing that the two pro­grams are the same class of drug — P2X3 re­cep­tor an­tag­o­nists — and Mer­ck’s re­sults came from a 45-mg dose. The class has been dinged for af­fect­ing a pa­tient’s abil­i­ty to taste, with more than half of Mer­ck’s high-dose pa­tients re­port­ing taste-re­lat­ed ad­verse events.

Bel­lus, mean­while, test­ed dos­es of 12.5 mg, 50 mg and 200 mg in the tri­al. An­a­lysts will like­ly be watch­ing close­ly for the taste-re­lat­ed side ef­fects here, de­pend­ing on which dose or dos­es passed the new Phase IIb pri­ma­ry. The biotech said on­ly that such events were “lim­it­ed” and “con­sis­tent” with what it’s seen in pre­vi­ous stud­ies.

Bel­lus shares have yet to re­cov­er from the 2020 flop as the biotech has hov­ered in pen­ny stock ter­ri­to­ry since peak­ing around $12 last year.

This ar­ti­cle has been up­dat­ed with com­ment from Bel­lus.

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.