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.

Purdue Pharma may soon be signing off on a guilty plea and an $8 million-plus settlement to wrap up its controversial role distributing OxyContin.

The AP has the breaking story this morning.

Purdue filed for bankruptcy last year, along with Insys and followed by Mallinckrodt, as it navigated its way through a blizzard of litigation surrounding Oxy, which triggered an epidemic of abuse around the country.

Prothena’s prasinezumab may not have met the primary endpoint in Phase II, but its partners at Roche are seeing enough to move it into a late-stage trial for Parkinson’s disease.

The Phase IIb will build on the Phase II PASADENA study, adding a subgroup of early Parkinson’s patients on stable levodopa therapy to the population.

It’s a significant milestone for a $600 million deal that dates back to 2013, as dosing of the first patient — expected next year — will trigger a $60 million milestone payment to Prothena.

A little less than two years after completing its $42 million Series B round, InCarda has returned to the venture well.

The San Francisco-based biotech announced the first portion of its Series C on Wednesday, pulling in $30 million in new funding. Most of the money will give enough runway for InCarda’s InRhythm program, an inhaled therapeutic aiming to treat sudden episodes of irregular heartbeats, through its Phase II trials and prepare it for Phase III.