It’s been just over a year and a half since Eli Lil­ly shelled out $1.1 bil­lion for Der­mi­ra and its old Roche castoff le­brik­izum­ab for atopic der­mati­tis. Now the phar­ma says it has the Phase III re­sults it was look­ing for — but are they good enough to ri­val Re­gen­eron and Sanofi’s block­buster Dupix­ent?

Ac­cord­ing to topline re­sults, the IL-13 in­hibitor helped more than half of adults and ado­les­cents in two tri­als achieve at least 75% clear­ance of their eczema (mea­sured by the Eczema Area and Sever­i­ty In­dex). The stud­ies met the pri­ma­ry and key sec­ondary end­points at Week 16, Eli Lil­ly said on Mon­day, in­clud­ing skin clear­ance and itch im­prove­ment.

The stud­ies — dubbed AD­vo­cate 1 and AD­vo­cate 2 — are part of five on­go­ing le­brik­izum­ab stud­ies, in­clud­ing two monother­a­py stud­ies and a com­bi­na­tion study. There are al­so longterm ex­ten­sion and ado­les­cent open la­bel tri­als in the works. The re­cent stud­ies en­rolled adults and ado­les­cents be­tween the ages of 12 and 18 with mod­er­ate-to-se­vere AD.

AD, al­so known as atopic eczema, is known to cause an in­tense, per­sis­tent itch that can af­fect sleep and dai­ly ac­tiv­i­ties.

In a Phase IIb study, a 250 mg dose of le­brik­izum­ab helped 44.6% of pa­tients achieve clear­ing or near-clear­ing of skin le­sions, as mea­sured by an IGA score of 0 or 1, and a re­duc­tion of at least 2 points from base­line, com­pared to 15.3% with place­bo (p=0.0023). And 60.6% of le­brik­izum­ab treat­ed pa­tients achieved a re­duc­tion of at least 75% from base­line in EASI-75, com­pared to 24.3% on place­bo (p=0.0005).

Eli Lil­ly says the full re­sults from AD­vo­cate 1 and 2 are com­ing in 2022.

And ac­cord­ing to some an­a­lysts, the num­bers bet­ter be good if Eli Lil­ly wants to chal­lenge Dupix­ent. The lat­ter is al­ready ap­proved for ado­les­cents and chil­dren as young as 6 years old with atopic der­mati­tis — and last year, the drug net­ted just over $4 bil­lion, ac­cord­ing to Sanofi. When com­bined with top­i­cal cor­ti­cos­teroids, 75% of chil­dren who re­ceived Dupix­ent in a Phase III tri­al achieved EASI-75, com­pared to just un­der 30% of pa­tients who got the cor­ti­cos­teroids alone, Re­gen­eron and Sanofi said.

When Eli Lil­ly ac­quired le­brik­izum­ab last Jan­u­ary, Jef­feries’ Biren Amin wrote:

While ini­tial ef­fi­ca­cy is promis­ing, we think the pro­file is not yet suf­fi­cient to dif­fer­en­ti­ate from Dupi, con­sid­er­ing the lat­ter’s first-to-mar­ket ad­van­tage. Fur­ther­more, the AD land­scape is in­creas­ing­ly com­pet­i­tive, which sug­gests new en­trants will face an ever-in­creas­ing bar to dif­fer­en­ti­ate from Dupi and each oth­er.

Lil­ly made it clear that le­brik­izum­ab was the star of its $1.1 bil­lion buy­out, lat­er sell­ing three an­ti-in­flam­ma­to­ry can­di­dates back to Der­mi­ra vets and mak­ing plans to shut­ter the biotech’s Men­lo Park fa­cil­i­ty, putting 163 jobs on the chop­ping block.

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

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.

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.”