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Submitted URL: https://e.endpointsnews.com/t/t-l-vthhuc-avhhfir-p/
Effective URL: https://endpts.com/aclaris-loses-85-of-share-value-after-another-phii-setback-in-inflammatory-condition/
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Doug Manion, Aclaris Therapeutics CEO
November 13, 2023 08:58 AM EST
R&D


ACLARIS LOS­ES 85% OF SHARE VAL­UE AF­TER AN­OTH­ER PHII SET­BACK IN
IN­FLAM­MA­TO­RY CON­DI­TION


KYLE LAHUCIK

SENIOR REPORTER

Aclaris Ther­a­peu­tics’ lead drug has failed an­oth­er mid-stage test, mark­ing
the biotech’s sec­ond ma­jor set­back this year and the au­toim­mune
treat­ment’s fi­nal shot in the clin­ic as fur­ther de­vel­op­ment will be
scrapped.

In re­ac­tion, in­vestors wiped about 85% off the com­pa­ny’s share price $ACRS
be­fore Mon­day’s open­ing bell. CEO Doug Man­ion told an­a­lysts the da­ta made
it “abun­dant­ly clear that ATI-450 is not ac­tive” in rheuma­toid arthri­tis.

Wayne, PA-based Aclaris said it will stop study­ing zunseme­tinib af­ter the
tablet failed a Phase IIb in rheuma­toid arthri­tis and will al­so
pre­ma­ture­ly end a Phase IIa in pso­ri­at­ic arthri­tis. In March, the small
mol­e­cule had al­so flunked a Phase II in hidradeni­tis sup­pu­ra­ti­va, a
chron­ic skin con­di­tion that mul­ti­ple bio­phar­mas are cur­rent­ly try­ing
to treat.

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“There is no doubt to­day’s read­out is a clear dis­ap­point­ment to us,”
Man­ion said on a call with an­a­lysts. “How­ev­er, I joined this com­pa­ny with
eyes wide open and with the un­der­stand­ing that drug dis­cov­ery and drug
de­vel­op­ment is not for the faint of heart.”

The biotech had bet on the idea that in­hibit­ing the MK2 path­way would be a
vi­able route for treat­ing im­muno-in­flam­ma­to­ry dis­eases giv­en its role
in dri­ving in­flam­ma­tion.

It will con­tin­ue study­ing an­oth­er oral MK2 in­hibitor in var­i­ous breast
and pan­cre­at­ic can­cers in an in­ves­ti­ga­tor-led Phase Ia at Wash­ing­ton
Uni­ver­si­ty. Man­ion said “there’s still mer­it to pro­ceed in on­col­o­gy
in­di­ca­tions be­cause the mech­a­nisms of ac­tion of MK2 in­hibitors are
dif­fer­ent than in im­muno-in­flam­ma­to­ry dis­eases.”

Giv­en the suc­ces­sive mid-stage set­backs, Aclaris will now turn its R&D
en­gine to­ward its top­i­cal JAK1/3 in­hibitor ATI-1777, which will have a
Phase IIb read­out in atopic der­mati­tis “around the end of the year,” the
com­pa­ny said.

If ATI-1777 clears the mid-stage test, Man­ion said Aclaris could take it in­to
Phase III on its own, but the CEO re­it­er­at­ed that the com­pa­ny doesn’t plan
on be­com­ing a com­mer­cial-stage drug­mak­er. It would ex­pect to find a
part­ner to bring the drug to mar­ket, he said. Aclaris di­vest­ed its ap­proved
rosacea cream Rho­fade in 2019 af­ter a strate­gic re­view.

Aclaris al­so plans to start a Phase II tri­al ear­ly next year for an oral
co­va­lent ITK/JAK3 in­hibitor in pa­tients with ul­cer­a­tive col­i­tis.

William Blair an­a­lyst Tim Lu­go said the Mon­day morn­ing re­sults give them
“cau­tion on the rest of Aclaris’ pipeline.”

Ear­ly da­ta from ATI-1777 “sug­gest com­pelling ef­fi­ca­cy in AD with­out the
ad­verse event bag­gage of the broad­er class of JAK in­hibitors and the
pos­i­tive Phase I re­sults from ATI-2138 adds an in­ter­est­ing
clin­i­cal-stage pipeline as­set with po­ten­tial for sig­nif­i­cant up­side,”
Lu­go said in an ear­ly note to clients, but Blair an­a­lysts are “cau­tious
giv­en the fail­ure of zunseme­tinib in RA and in HS.”

With $187 mil­lion on hand at the end of Sep­tem­ber, Aclaris has run­way un­til
the end of 2025, Man­ion said.




AUTHOR


KYLE LAHUCIK

SENIOR REPORTER

klahucik@endpointsnews.com @ky_lahucik
Kyle LaHucik on LinkedIn


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