An­oth­er NASH pro­gram is head­ed to the scrap heap.

Al­bireo $AL­BO, a Boston biotech that took an un­con­ven­tion­al route to treat­ing the fat­ty liv­er dis­ease, an­nounced yes­ter­day that they were end­ing NASH de­vel­op­ment af­ter they re­ceived dis­ap­point­ing re­sults from a Phase II study. Just last week CEO Ron Coop­er, on their Q2 call, talked up their off­beat ap­proach and the po­ten­tial for their lead mol­e­cule to be used in com­bi­na­tion with agents now in de­vel­op­ment at oth­er coun­tries.

Ron Coop­er

On Tues­day, he em­pha­sized that Al­bireo’s in­vest­ment in the pro­gram was min­i­mal.

“We want­ed to in­ves­ti­gate the po­ten­tial of elo­bix­i­bat in NASH and al­lo­cat­ed min­i­mal re­sources to an ex­plorato­ry Phase 2 study,” Coop­er said in a state­ment. “Based on the re­sults of this study, we have made the de­ci­sion not to pur­sue fur­ther de­vel­op­ment of elo­bix­i­bat in NASH.”

Com­pared to the stock-melt­ing hits com­pa­nies such as Gen­Fit have tak­en af­ter their tri­al fail­ures, Al­bireo emerges from their NASH ex­plo­ration rel­a­tive­ly un­scathed. Their lead pro­grams are in oth­er liv­er con­di­tions, bile atre­sia and PF­IC, and the com­pa­ny took on­ly a 4.85% hit on the news, drop­ping from $27.01 to $25.70.

Still, the failed pro­gram is an­oth­er blow to a field that has seen lit­tle but fail­ure since JP Mor­gan 2019, when mul­ti­ple com­pa­nies seemed poised to break in­to a mar­ket es­ti­mat­ed to have mil­lions of pa­tients and room for mul­ti­ple mega-block­busters. Since then Gilead, Gen­Fit and a se­ries of small­er biotechs have seen ma­jor tri­al fail­ures. And, af­ter the FDA sur­pris­ing­ly re­ject­ed an In­ter­cept drug that showed mixed re­sults in Phase III, de­vel­op­ers have been left in lim­bo about what the bar for ef­fi­ca­cy will be.

Odd­ly enough, Al­bireo ac­tu­al­ly hit the pri­ma­ry end­point on their study. Coop­er in­sist­ed that he saw the dis­ease, large­ly dri­ven by obe­si­ty and sim­i­lar health fac­tors, as fun­da­men­tal­ly a car­dio­vas­cu­lar ail­ment.

So un­like In­ter­cept, Gen­fit and the rest of the biotechs that fo­cused on fi­bro­sis and NASH res­o­lu­tion, Al­bireo set up a tri­al de­signed to prove their lead drug, elo­bix­i­bat, could im­prove pa­tients’ cho­les­terol and show “proof-of-con­cept” on liv­er-spe­cif­ic end­points, such as liv­er fat and func­tion. If so, it could be used in tan­dem with oth­er fu­ture NASH drugs, as re­searchers in­creas­ing­ly turn to com­bi­na­tion ther­a­pies for the dis­ease.

Ul­ti­mate­ly, though, elo­bix­i­bat could do on­ly the for­mer. In the 47-per­son study, pa­tients on the treat­ment arm saw their cho­les­terol fall al­most twice as much as pa­tients on the place­bo arm (-20.5 mg/dL vs -11.1 mg/dL), but there was lit­tle to no change in liv­er end­points. Liv­er fat fell by 2.6% for the treat­ment arm, as mea­sured by MRI, and there was “no mean­ing­ful change” in lev­els of ala­nine amino­trans­ferase, a liv­er en­zyme com­mon­ly used to mea­sure func­tion.

The first batch of pivotal data on Autolus Therapeutics’ CAR-T is in, and execs are ready to plot a path to market.

With an overall remission rate of 70% at the interim analysis featuring 50 patients, the results set the stage for a BLA filing by the end of 2023, said CEO Christian Itin.

Perhaps more importantly — given that Autolus’ drug, obe-cel, is going after an indication that Gilead’s Tecartus is already approved for — the biotech highlighted “encouraging safety data” in the trial, with a low percentage of patients experiencing severe immune responses.

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.