Anap­tys­Bio's etokimab pro­vides more dis­ap­point­ing re­sults, rais­ing ques­tions about com­pound's fu­ture

The lead pro­gram for Anap­tys­Bio’s in-house pipeline has hit an­oth­er set­back.

Etokimab, an IL-33 in­hibitor, did not achieve sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in a Phase II tri­al for pa­tients suf­fer­ing from chron­ic rhi­nos­i­nusi­tis with nasal polyps. Re­searchers mea­sured the in­di­vid­u­als’ bi­lat­er­al nasal polyps score and sino-nasal out­come test, find­ing that nei­ther im­proved up­on a place­bo af­ter both four- and eight-week time mark­ers, though they did demon­strate im­prove­ment over base­line lev­els of the ex­am­i­na­tions.

Anap­tys­Bio an­nounced the in­ter­im re­sults as part of a sec­ond-quar­ter earn­ing read­out.

Hamza Suria

“While we are dis­ap­point­ed with the re­cent in­ter­im analy­sis re­sults from our on­go­ing ECLIPSE tri­al, we look for­ward to ad­di­tion­al Phase II clin­i­cal tri­al read­outs an­tic­i­pat­ed over the up­com­ing quar­ters,” Anap­tys­Bio pres­i­dent and CEO Hamza Suria said in a state­ment.

The com­pa­ny added that it will re­assess the plan for the etokimab pro­gram fol­low­ing the 16-week mark­er near the end of 2020.

Mon­day’s un­der­whelm­ing re­sults are not the first for etokimab, as chron­ic rhi­nos­i­nusi­tis with nasal polyps is not the can­di­date’s main tar­get. Anap­tys­Bio orig­i­nal­ly test­ed the com­pound for treat­ment of atopic der­mati­tis, hop­ing to chal­lenge Re­gen­eron and Sanofi’s mar­ket-lead­ing Dupix­ent, but had to dis­con­tin­ue de­vel­op­ment af­ter both dos­ing arms of a Phase IIb tri­al failed to meet the pri­ma­ry end­point of the study.

That tri­al flop had been dubbed the “worst-case sce­nario” by an­a­lysts and sunk the com­pa­ny’s stock more than 70% at the time. In­vestors had ex­pect­ed etokimab to reach sim­i­lar lev­els of ef­fi­ca­cy to Dupix­ent with less fre­quent dos­ing, but that didn’t hap­pen. The mar­ket for atopic der­mati­tis, which is es­ti­mat­ed to af­fect some 24 mil­lion Amer­i­cans, is ex­pect­ed to hit $18.3 bil­lion by 2027, ac­cord­ing to Glob­al­Da­ta.

The can­di­date is al­so be­ing stud­ied to treat eosinophilic asth­ma, but Anap­tys­Bio post­poned the Phase IIb tri­al fol­low­ing the re­sults from the atopic der­mati­tis study. Per the com­pa­ny’s web­site, it plans to wait un­til the full re­sults of the chron­ic rhi­nos­i­nusi­tis study be­come avail­able be­fore ini­ti­at­ing the tri­al.

Ad­di­tion­al­ly, this is not the first time Anap­tys­Bio has been in the news re­cent­ly. Just last month, the FDA grant­ed or­phan drug des­ig­na­tion for im­si­dolimab, the com­pa­ny’s IL-36 in­hibitor to treat gen­er­al­ized pus­tu­lar pso­ri­a­sis. Reg­u­la­tors are ex­pect­ed to pro­vide an up­date on the can­di­date, which is in a Phase II tri­al, be­fore 2020 is out.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

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Samit Hirawat (Bristol Myers Squibb)

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The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

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Anthony Coyle (Repertoire)

Flag­ship's merged biotech Reper­toire nets ex-Pfiz­er CSO An­tho­ny Coyle as R&D chief

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Repertoire Immune Medicines, which already boasts former Bioverativ chief John Cox as its CEO, announced yesterday that Anthony Coyle, the former Pfizer CSO and the founding CEO of Pandion, will join as their head of R&D.

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Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

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President Donald Trump (via AP Images)

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Jeff Goldberg was getting acquainted with a brand new way to do corneal transplants when an even newer, even bolder idea hit him.

It was almost 10 years ago, and Goldberg was in his first faculty position at Bascom Palmer Eye Institute at the University of Miami. Scientists had developed a new way to do cornea transplants where instead of sewing a whole donor cornea — a decades-old practice — they were just engrafting the inner layer of cells.

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Embattled CDC director Robert Redfield (AP Images)

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A federal committee that advises the CDC was expected to hold a vote Tuesday on a plan regarding the distribution for initial doses of approved Covid-19 vaccines. But that vote has been scrapped.

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Zai Lab hauls in $761M from Hong Kong IPO to push Ze­ju­la, more bud­ding can­di­dates in Chi­na — re­port

Zai Lab is set to net more than $761 million from its secondary listing in Hong Kong after pricing the IPO at $72.51 (HKD$562) — just a hair below its Nasdaq closing price on Monday, Bloomberg and Nikkei Asian Review reported.

A pioneer in bringing Western drugs to China, co-founder and CEO Samantha Du has more than tripled Zai Lab’s market cap in the three years it’s been public in the US. The HKEX listing is designed to fund R&D and commercialization for the current portfolio while fueling new in-licensing pacts, the biotech wrote in a filing.