About a year and a half af­ter pre­sent­ing pos­i­tive topline re­sults in Crohn’s dis­ease, Eli Lil­ly gave its ex­per­i­men­tal IL-23 an­ti-in­flam­ma­to­ry mirik­izum­ab a boost Mon­day with new da­ta.

The fresh in­fo comes from the Phase II study and is a 52-week fol­low-up of the orig­i­nal tri­al. Mirik­izum­ab showed that, af­ter the ini­tial 12-week pe­ri­od, pa­tients who con­tin­ued treat­ment for an­oth­er 40 weeks saw fur­ther im­prove­ment in en­do­scop­ic re­sponse and Pa­tient-Re­port­ed Out­comes re­mis­sion.

Lo­tus Mall­bris

“We are very ex­cit­ed about this da­ta; this is the first dis­clo­sure of both new ef­fi­ca­cy and safe­ty that shows not on­ly an im­me­di­ate re­sponse, but most im­por­tant­ly, a con­tin­u­ous ef­fi­ca­cy re­sponse,” Lil­ly glob­al im­munol­o­gy chief Lo­tus Mall­bris told End­points News.

Orig­i­nal­ly, the tri­al mea­sured three dif­fer­ent dos­es for en­do­scop­ic re­sponse against a place­bo at week 12. The study met the pri­ma­ry end­point as high­er dos­es pro­gres­sive­ly saw greater re­sponse, with 25.8%, 37.5%, and 43.8% of pa­tients hit­ting the mark com­pared to 10.9 per­cent of place­bo pa­tients.

PRO re­mis­sion was a sec­ondary end­point in that study por­tion, and it was achieved in 12.9%, 28.1% and 21.9% of pa­tients in the three dos­ing arms, com­pared to 6.3% of pa­tients treat­ed with place­bo.

In the fol­low-up pe­ri­od, Eli Lil­ly eval­u­at­ed fur­ther ef­fi­ca­cy and safe­ty as well as two dos­ing meth­ods — in­tra­venous and sub­cu­ta­neous ad­min­is­tra­tion. Af­ter 12 weeks, pa­tients who showed en­do­scop­ic im­prove­ment were ran­dom­ized to con­tin­ue mirik­izum­ab ei­ther through IV or or in­jec­tion. Those who did not show en­do­scop­ic im­prove­ment or who had been orig­i­nal­ly ran­dom­ized to place­bo all re­ceived IV treat­ment cours­es.

At the end of 52 weeks, 58.5% of pa­tients in the IV dos­ing group saw an en­do­scop­ic re­sponse, as well as 58.7% in the oth­er group. Ad­di­tion­al­ly, PRO re­mis­sion was achieved by 46.3% of pa­tients dosed through an IV and 45.6% dosed by in­jec­tion. There was no place­bo group in the fol­low-up pe­ri­od.

“Not on­ly did we con­tin­ue with the pa­tients who were re­spon­ders, the pa­tients that were not re­spond­ing in any dose in­clud­ing place­bo got a sec­ond chance to see if they could re­spond,” Mall­bris said. “And that’s the key here, you give the pa­tients a sec­ond chance to get treat­ment.”

Eli Lil­ly de­fined en­do­scop­ic re­sponse as at least a 50% re­duc­tion in bow­el lin­ing in­flam­ma­tion as seen dur­ing an en­doscopy. Mean­while, PRO re­mis­sion was char­ac­ter­ized as an av­er­age dai­ly stool fre­quen­cy of less than or equal to 2.5 times and ab­dom­i­nal pain less than or equal to 1. Mirik­izum­ab has since moved on­to Phase III in Crohn’s dis­ease af­ter Eli Lil­ly re­port­ed the topline re­sults.

The In­di­anapo­lis-based phar­ma is test­ing the pro­gram in two oth­er in­di­ca­tions as well: pso­ri­a­sis and ul­cer­a­tive col­i­tis. Tri­als for both fields are al­so in Phase III, with mirik­izum­ab show­ing su­pe­ri­or­i­ty to No­var­tis’ IL-17 drug Cosen­tyx for pso­ri­a­sis back in Ju­ly. Phase III da­ta in UC are ex­pect­ed some­time in the first half of 2021, Mall­bris said, with Phase III Crohn’s da­ta still a ways away giv­en that the tri­al just be­gan en­roll­ment.

How­ev­er, Ab­b­Vie may have beat­en Lil­ly to the punch with its IL-23 Skyrizi, which is al­ready ap­proved and demon­strat­ed even bet­ter num­bers com­pared to Cosen­tyx. Eli Lil­ly doesn’t have any cur­rent­ly ap­proved drugs in UC or Crohn’s and every­thing in the field is chas­ing the Ab­b­Vie block­buster Hu­mi­ra, ap­proved for a swath of au­toim­mune con­di­tions. Ab­b­Vie is po­si­tion­ing Skyrizi as a po­ten­tial suc­ces­sor to the TNF block­er, with peak sales es­ti­mat­ed as high as $5 bil­lion by its ex­ec­u­tive team.

Mall­bris said the ul­ti­mate goal for mirik­izum­ab is to be­come the first IL-23 ap­proved for UC as that are­na has seen less de­vel­op­ment than pso­ri­a­sis and Crohn’s.

“There are few­er bi­o­log­ics [in UC]. The ef­fi­ca­cy of those bi­o­log­ics is not re­al­ly sat­is­fac­to­ry,” Mall­bris said.

Nearly a year ago, as the pandemic encroached and the stock market cratered, Flagship and ARCH Venture announced three mega-funds worth a combined $2.6 billion. They wanted, ARCH’s Bob Nelsen said, to restore confidence “that there was money out there and a lot of it” to invest in biotech.

Since then, the stock market has returned — almost frighteningly so — and Nelsen has kept raising and spending cash. On Thursday, he announced a new fund, worth $1.85 billion. It’s the largest pot yet for a VC famous for its deep pockets.

Japanese drugmaker Takeda has made a big push in recent years to build a hand in oncology, particularly in the next-gen cancer space. One of those candidates, tyrosine kinase inhibitor (TKI) mobocertinib, recently earned the FDA’s interest in a small section of untreated lung cancer patients, but will severe GI side effects be a roadblock?

Takeda’s oral mobocertinib posted clinically significant objective response rates in a Phase I/II adaptive trial drugging metastatic non-small cell lung cancer patients with EGFR exon 20 gene mutations who had previously undergone platinum-based chemotherapy, according to data presented Thursday at the virtual World Conference on Lung Cancer.

Even though Dean Li has now officially taken over for Roger Perlmutter as R&D chief, Merck’s appetite for dealmaking continues to be ravenous.

Li struck his first big deal at the helm Thursday morning, hammering out a collaboration with Artiva Biotherapeutics that could earn the biotech nearly $1.9 billion when all is said and done. It’s a quick rise and validation for Artiva, which just last June launched with a $78 million Series A.