Till­man Gern­gross cer­tain­ly wasn’t the first to tack­le Covid-19 an­ti­bod­ies, but he has rea­son to be­lieve he and his team at Ada­gio could be the best. Now, we’re get­ting a first peek at hu­man pre­ven­ta­tive da­ta for Ada­gio’s lead an­ti­body, and it looks up to par with the best of the vac­cines.

Now, Ada­gio is churn­ing out ear­ly da­ta from that Phase I test show­ing a sin­gle dose of an­ti­body ADG20 of­fered broad­ly neu­tral­iz­ing ac­tiv­i­ty in healthy vol­un­teers com­pa­ra­ble to peak titers re­port­ed from the mR­NA vac­cines and could of­fer pro­tec­tion for up to 12 months, the biotech said Wednes­day. There were no hard num­bers im­me­di­ate­ly avail­able.

Based on those find­ings, Ada­gio has launched its glob­al Phase II/III EVADE study that will test ADG20 in both the pre- and post-ex­po­sure set­tings at 100 sites. The study will eval­u­ate an ini­tial 200 adults in Phase II be­fore po­ten­tial­ly open­ing en­roll­ment to ado­les­cents and preg­nant women in Phase III. The pri­ma­ry ef­fi­ca­cy end­point in both co­horts is the pre­ven­tion of lab­o­ra­to­ry con­firmed, symp­to­matic Covid-19, Ada­gio said.

Lynn Con­nol­ly

“Based on its po­tent and broad ac­tiv­i­ty and ex­tend­ed du­ra­tion of ef­fect in pre­clin­i­cal mod­els, we be­lieve that ADG20 has the po­ten­tial to pro­vide both rapid pro­tec­tion in the face of a known, re­cent ex­po­sure to an in­di­vid­ual with SARS-CoV-2 in­fec­tion as well as durable pro­tec­tion over sev­er­al months, in­clud­ing for in­di­vid­u­als who are un­like­ly to have a suf­fi­cient­ly pro­tec­tive im­mune re­sponse to vac­cines,” CMO Lynn Con­nol­ly said in a state­ment.

Based on sci­ence from Gern­gross and his team at Adimab, Ada­gio has made a late push to bring a bet­ter Covid-19 an­ti­body to mar­ket af­ter some mixed re­sults from drug­mak­ers who raced oth­er can­di­dates to mar­ket and have seen lim­it­ed ef­fi­ca­cy against vari­ants.

In April, Ada­gio snared $336 mil­lion as part of a Se­ries C round led by RA Cap­i­tal to ad­vance ADG20 through a piv­otal Phase I/II/III tri­al for the treat­ment of high-risk, mild to mod­er­ate Covid-19 pa­tients. That tri­al, dubbed STAMP, stands apart from the pre­ven­ta­tive study Ada­gio read out Thurs­day.

The com­pa­ny be­lieves its an­ti­bod­ies have broad­ly neu­tral­iz­ing po­ten­tial against the SARS-CoV-2 emerg­ing vari­ants as well as oth­er sar­be­covirus­es apart from the nov­el coro­n­avirus, Ada­gio said. That could mean some stay­ing pow­er post-Covid.

STAMP is de­signed to rapid­ly turn out proof-of-con­cept da­ta that could form the ba­sis for an emer­gency use au­tho­riza­tion fil­ing, Ada­gio said.

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From 2018 through 2020, Novartis received almost 32,000 requests from 77 countries to use one of the company’s experimental drugs (known as “compassionate use” requests, or in the US, “expanded access“) for patients with serious or life-threatening medical conditions.

But when the requests were divided by each participating country’s GDP, the Novartis researchers found that just 0.5% of the requests came from lower-middle- and lower-income countries. When stratified by gross national income, only 3% of the requests came from lower-middle- and lower-income countries.

Amazon’s online pharmacy has settled a lawsuit in New York after allegations of overbilling for the lifesaving drug insulin.

The settlement resolves allegations that the pharmacy, known as PillPack, improperly billed government healthcare programs like Medicare and Medicaid for more insulin pens than patients needed according to their prescriptions, and for falsely under-reporting the days insulin supplies were dispensed.

The Singapore-based CRO Novotech has acquired NCGS to expand its global offerings for clients, and finally offer its full-service high-quality clinical services to customers in the US.

NCGS has been in Charleston, SC since 1984. The CRO has about 300 employees across the US and focuses on the clinical development of oncology, hematology, infectious disease and CNS in adults and children. On its website, it boasts of having 80 approved products and zero Form 483s or FDA warning letters.

From the start of Incyte’s Q1 earnings call, the manufacturing issues surrounding Opzelura were addressed by Hervé Hoppenot, the company’s CEO. And though issues have slowed the treatment back, the pharma said it added a second manufacturing site to produce the atopic dermatitis drug, and implemented a new process after gaining FDA approval.

“Consistent with best practices, we have received FDA approval for a second manufacturer of Opzelura to support our successful launch,” he said, before handing things over to US general manager Barry Flannelly. “We are also preparing to reintroduce samples in the US.”