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.

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

The first in vivo CRISPR/Cas9 gene editing program has some new durability data showing sustained reduction of a toxic protein in ATTR amyloidosis at all four dose levels in a small 15-patient study.

Intellia Therapeutics presented the much-anticipated data for its Regeneron-collaborated NTLA-2001 Friday morning, adding to the initial Phase I results it first delivered almost a year ago to the day.

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”