Aim­ing to up­root the mar­ket for asth­ma at­tacks, As­traZeneca and Avil­lion tout two PhI­II wins for in­haled com­bo drug

A col­lab­o­ra­tion launched in 2018 be­tween As­traZeneca and British com­pa­ny Avil­lion is bear­ing new fruit Thurs­day for a se­vere asth­ma pro­gram.

The As­traZeneca and Avil­lion can­di­date, dubbed PT027, met all pri­ma­ry end­points in two Phase III stud­ies, the com­pa­nies an­nounced Thurs­day. A com­bi­na­tion of the short-act­ing be­ta2-ag­o­nist (SA­BA) al­buterol — a com­mon asth­ma med­ica­tion — and the in­haled cor­ti­cos­teroid budes­onide, PT027 is po­si­tioned to be­come the new stan­dard of care for asth­ma res­cue ther­a­py, As­traZeneca se­nior VP for res­pi­ra­to­ry and im­munol­o­gy Mi­na Makar told End­points News.

Mi­na Makar

“For 40 or 50 years plus, al­buterol has been the stan­dard of care to treat acute symp­toms of asth­ma,” Makar said. “But for all of these years, part of the chal­lenge has been that al­buterol has not been treat­ing the un­der­ly­ing in­flam­ma­tion of the asth­ma, where pa­tients be­gin to over-re­ly on their al­buterol in­halers and not get any re­lief of symp­toms.”

Fur­ther da­ta from more PT027 stud­ies are ex­pect­ed in the first half of next year, but Makar said As­traZeneca and Avil­lion have every­thing they need right now to go to reg­u­la­tors. The com­pa­nies ex­pect to file for ap­proval some­time in 2022.

Re­gard­less of an in­di­vid­ual’s asth­ma sever­i­ty, the vast ma­jor­i­ty of pa­tients car­ry around al­buterol in­halers in case they ex­pe­ri­ence an asth­ma at­tack. The med­i­cine works by loos­en­ing the con­stric­tion of smooth mus­cle in the lungs, but does noth­ing to ad­dress the un­der­ly­ing in­flam­ma­tion of the con­di­tion, Makar said.

Where PT027 hopes to step in is by adding the in­haled cor­ti­cos­teroid to al­buterol as part of the res­cue ther­a­py. It’s a treat­ment that has proven safe among oth­er asth­ma main­te­nance sup­ple­ments like Sym­bi­cort and Trel­e­gy, he added. But the idea be­hind PT027 is that by com­bin­ing the two in the res­cue as­pect, pa­tients will be more like­ly to avoid hos­pi­tal­iza­tion from se­vere at­tacks and the need for oral steroids.

“Those have sig­nif­i­cant tox­i­c­i­ty and bur­den for pa­tients in re­duc­ing ex­ac­er­ba­tions,” Frank Tru­do, As­traZeneca VP of med­ical af­fairs for res­pi­ra­to­ry and im­munol­o­gy, told End­points.

Frank Tru­do

Thurs­day’s an­nounce­ment comes from two late-stage tri­als, en­rolling rough­ly 4,100 pa­tients across the asth­ma spec­trum. The first study saw about 3,100 in­di­vid­u­als with mod­er­ate to se­vere asth­ma tak­ing main­te­nance ther­a­py, while the sec­ond re­cruit­ed about 1,000 pa­tients with mild to mod­er­ate asth­ma who had pre­vi­ous­ly re­ceived a SA­BA or main­te­nance as need­ed.

In the larg­er tri­al, PT027 sta­tis­ti­cal­ly sig­nif­i­cant­ly re­duced the risk of se­vere ex­ac­er­ba­tions com­pared to al­buterol alone, when used as a res­cue ther­a­py in re­sponse to an asth­ma at­tack. As­traZeneca and Avil­lion did not re­lease ex­act fig­ures or a p-val­ue, how­ev­er, not­ing on­ly that the pri­ma­ry was met at both the 180/160 μg and 180/80 μg dos­es.

The sec­ond study mea­sured for a pri­ma­ry end­point against both a com­para­tor and place­bo, with re­searchers look­ing at lung func­tion. Again at both dose lev­els, PT027 showed a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in lung func­tion mea­sured by the FEV1 test, or how much air an in­di­vid­ual can breathe out in one sec­ond when forcibly ex­hal­ing.

This study al­so re­port­ed no ex­act fig­ures or p-val­ues. As­traZeneca and Avil­lion looked at the PT027 dos­es in com­par­i­son to al­buterol alone, budes­onide alone and place­bo.

As­traZeneca orig­i­nal­ly got the ball rolling with Avil­lion back in March 2018, when the com­pa­nies agreed to co-de­vel­op PT027 for asth­ma. Avil­lion took on all clin­i­cal de­vel­op­ment with As­traZeneca get­ting an op­tion to com­mer­cial­ize and mar­ket the drug in the US up­on a suc­cess­ful ap­proval.

Now with the piv­otal Phase III da­ta in hand, Makar said the pair will need to ini­ti­ate a “com­pre­hen­sive” ed­u­ca­tion pro­gram for pa­tients and physi­cians, giv­en how long al­buterol has been used. But As­traZeneca is pre­pared to do that as it pre­pares the can­di­date for launch.

“Pa­tients and physi­cians are very used to [al­buterol] be­ing the so­lu­tion for acute symp­toms,” Makar said. The pro­grams will em­pha­size how there “needs to be in­haled steroid to deal with the un­der­ly­ing in­flam­ma­tion” in ad­di­tion to al­buterol.

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