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.

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.