Warts for the win: Aclar­is' lead drug clears piv­otal study

Aclaris Ther­a­peu­tics has found a way to get rid of the warts and all.

The com­pa­ny — which ear­li­er this month de­cid­ed to fo­cus on its ar­se­nal of ki­nase in­hibitors — on Mon­day un­veiled pos­i­tive da­ta from a piv­otal study test­ing its lead ex­per­i­men­tal drug for use in com­mon warts.

The drug, A-101, was test­ed in a 502-pa­tient study called THWART-2 — pa­tients en­rolled had one to six warts be­fore qual­i­fy­ing for the tri­al. Pa­tients ei­ther self-ad­min­is­tered A-101 top­i­cal so­lu­tion or a ve­hi­cle twice a week over a two-month pe­ri­od. A high­er pro­por­tion of pa­tients on the drug (a po­tent hy­dro­gen per­ox­ide top­i­cal so­lu­tion) saw their warts dis­ap­pear at day 60, ver­sus the ve­hi­cle (p<0.0001) — meet­ing the main goal of the study.  Each sec­ondary end­point al­so emerged in fa­vor of A-101, the com­pa­ny said.

Shares of the Wayne, Penn­syl­va­nia-based com­pa­ny $ACRS soared about 65.5% to $1.82 in pre­mar­ket trad­ing on Fri­day.

An­oth­er late-stage tri­al in com­mon warts is on­go­ing, and da­ta are ex­pect­ed in the fourth quar­ter.

“Giv­en no FDA ap­proved treat­ments for com­mon warts, which im­pacts 22M Amer­i­cans each year, it seems that there would be a rel­a­tive­ly ‘low bar’ for A-101 45% to re­ceive ap­proval, as­sum­ing the con­fir­ma­to­ry Ph3 THWART-1 da­ta al­so reads out pos­i­tive­ly,” Jef­feries an­a­lysts wrote in a note.

“With on­ly topline in­for­ma­tion, it is dif­fi­cult to com­pare to the pri­or A-101 Ph2 datasets as well as VR­CA’s re­cent­ly re­port­ed Ph2 da­ta for VP-102 in treat­ing com­mon warts.”

Ver­ri­ca Phar­ma­ceu­ti­cals $VR­CA ear­li­er this year dis­closed pos­i­tive da­ta from an open-la­bel mid-stage study test­ing its drug, VP-102, in pa­tients with up to six warts. Da­ta skewed in fa­vor of VP-102 on the pri­ma­ry end­point of com­plete clear­ance of all treat­able warts at day 84, as well as the sec­ondary goal of the per­cent­age re­duc­tion of warts. The top­i­cal ther­a­py com­pris­es a so­lu­tion of 0.7% can­tharidin — a blis­ter-in­duc­ing agent se­cret­ed by cer­tain bee­tles — which was his­tor­i­cal­ly used as an aphro­disi­ac. Top­i­cal can­tharidin has been used on warts and mol­lus­cum since the 1950s, al­though the chem­i­cal lost FDA ap­proval in 1962 af­ter man­u­fac­tur­ers failed to fur­nish ad­e­quate ev­i­dence sup­port­ing its ef­fi­ca­cy.

Weeks ago, Aclaris con­clud­ed a strate­gic re­view of its busi­ness — re­solv­ing to fo­cus its re­sources on its im­muno-in­flam­ma­to­ry pipeline (en­com­pass­ing ATI-450, ATI-1777 and oth­er pre­clin­i­cal drug can­di­dates). It is now look­ing for part­ners on its com­mer­cial busi­ness: Rosacea treat­ment Rhophade and se­b­or­rhe­ic ker­atoses ther­a­py Es­ka­ta. In ad­di­tion, the com­pa­ny is al­so seek­ing part­ners for a tri­fec­ta of ther­a­pies in de­vel­op­ment — ex­per­i­men­tal warts drug A-101, as well as the in­ves­ti­ga­tion­al alope­cia treat­ments ATI-501 (oral) and ATI-502 (top­i­cal).

As a re­sult, the com­pa­ny an­nounced 86 lay­offs. The re­struc­tur­ing is ex­pect­ed to keep the lights on un­til the third quar­ter of 2021.

“While we hold the mgt team in high re­gard as thought lead­ers in der­ma­tol­ogy, the com­pa­ny has ex­e­cut­ed poor­ly over the past year (e.g., botched Es­ka­ta launch, mixed clin­i­cal da­ta for the JAK alope­cia pro­grams)…” Jef­feries an­a­lysts said in a note dat­ed Sep­tem­ber 6.

In June, the com­pa­ny suf­fered a set­back af­ter a mid-stage study test­ing ATI-502 failed to im­prove scalp hair cov­er­age, which crushed its stock. Aclaris paid Rigel Phar­ma $8 mil­lion up­front in 2017 for glob­al li­cens­es to both ATI-501 and ATI-502.

The dis­clo­sure came days af­ter the FDA rep­ri­mand­ed the com­pa­ny for mak­ing “false or mis­lead­ing claims” in a pro­mo­tion­al video for Es­ka­ta.

“That said, we see val­ue in the cur­rent cap­i­tal­iza­tion. Look­ing ahead, with a sub $40M mar­ket val­ue (trad­ing at ~0.45x net cash), ACRS shares could re­bound if mgt can ex­e­cute on its re­vamped strat­e­gy,” the an­a­lysts added.

Janet Woodcock (AP Images)

Janet Wood­cock is in the run­ning for FDA com­mis­sion­er — what does that mean for the agen­cy's fu­ture?

Just a day after reports emerged that Janet Woodcock will serve as interim chief of the FDA, word has gotten out that she is also in the running for the permanent job.

The decision, as the initial wave of reactions suggest, could have dramatic implications for where the agency is headed in the next four years — if not beyond.

Woodcock, the longtime CDER director, is being vetted alongside former FDA principal deputy commissioner Joshua Sharfstein, Bloomberg reported. Already tapped as acting head of the agency, she’s set to take over from Stephen Hahn right after Biden’s inauguration next week.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,000+ biopharma pros reading Endpoints daily — and it's free.

Janet Woodcock (AP Images)

Janet Wood­cock to be act­ing FDA com­mis­sion­er while Biden team fi­nal­izes nom­i­nee — re­ports

Janet Woodcock is set to be the most powerful person at the FDA in less than a week.

The veteran regulator and longtime director of the Center for Drug Evaluation and Research has been tapped as acting commissioner of the FDA, according to reports by BioCentury’s Steve Usdin and Pink Sheet’s Sarah Karlin-Smith.

The appointment was requested by the incoming Biden team, Karlin-Smith added, as they sort out the nomination of a permanent successor to Stephen Hahn — whose one-year tenure has been defined by Covid-19.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,000+ biopharma pros reading Endpoints daily — and it's free.

CEO Brett Monia (Ionis)

Can Brett Mo­nia push Io­n­is be­yond Spin­raza?

For 30 years, Brett Monia struggled as one of Ionis’ top scientists to get their antisense technology to work. Now, as CEO, he’s trying to use it to turn Ionis into one of the industry’s biggest biotechs.

Monia, one of the handful of young scientists who in 1989 followed Stanley Crooke across the country from SmithKline (now GSK) in Philadelphia to found Ionis in Northern California, replaced Crooke as CEO last January. By then, they had proven antisense, an RNA-based method for manipulating gene expression, could work dramatically well in at least some instances, transforming spinal muscular atrophy with the Biogen-partnered blockbuster Spinraza.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,000+ biopharma pros reading Endpoints daily — and it's free.

Terry Rosen, Arcus CEO

Gilead part­ner Ar­cus earns an­a­lyst­s' plau­dits for ear­ly pan­cre­at­ic can­cer da­ta that 'ex­ceed­ed ex­pec­ta­tion­s'

Arcus’ small molecule CD73 inhibitor for pancreatic cancer got a standing ovation from analysts who said preliminary data “exceeded expectations”— making waves in a field that’s seen little progress in several years and proving the candidate could be worth the hundreds of millions Gilead provided upfront in a deal that included more than a billion dollars for opt-in rights and milestones.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,000+ biopharma pros reading Endpoints daily — and it's free.

Steve Harr (L) and Hans Bishop

Paint­ing by the num­bers, Sana founders carve up a gi­ant uni­corn-sized IPO — for a biotech that has­n't quite made it to the clin­ic

Sana Biotechnology is one of those startups that was sketched in on the chalkboard day one in the shape of a unicorn.

A giant unicorn.

And from the numbers the cell therapy 2.0 play spelled out in their S-1 $SANA, it’s clear that the company founders — led by a pair of major VCs aligned with some high-profile industry figures — are hunting a big chunk of that value for themselves.

The raise they penciled in — $150 million — isn’t likely what they actually have in mind, and it doesn’t do justice to the size of their ambitions.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

David Kessler in April 2009 (Eric Risberg/AP Images)

Covid-19 roundup: Hack­ers start re­leas­ing 'ma­nip­u­lat­ed' Covid-19 vac­cine docs; Ex-FDA com­mish David Kessler to re­place Mon­cef Slaoui as Op­er­a­tion Warp Speed chief — re­port

There’s a new twist on the EMA Covid-19 hacking story.

Friday the European agency put out the 5th in a series of statements about the hackers who broke into their system, noting that some of the information on vaccines that was gleaned in the attack is showing up online — altered to raise questions about the Covid-19 vaccines now in use.

This included internal/confidential email correspondence dating from November, relating to evaluation processes for COVID-19 vaccines. Some of the correspondence has been manipulated by the perpetrators prior to publication in a way which could undermine trust in vaccines.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,000+ biopharma pros reading Endpoints daily — and it's free.

Nadim Ahmed (Bristol Myers Squibb)

Bris­tol My­er­s' top hema­tol­ogy ex­ec is on his way out — right on the heels of a $6B CVR im­plo­sion

Fourteen days after the $6.3 billion CVR tied to the approval of liso-cel went up in smoke, one of the top execs in charge of the work at Bristol Myers Squibb is preparing to step out of his job.

Mizuho analyst Salim Syed, who’s been following every twist and turn in the CVR saga, told investors on Thursday morning that Nadim Ahmed is on his way out. Syed’s note:

Recall, Ahmed is EVP and President of Hematology at BMY (i.e. JCAR017 and bb2121 are both hematological drugs). He’s still listed on the BMY management page. This is true — he’s still technically there. However, I have confirmed w/ BMY that his last day is tomorrow, Friday 1/15. To my best knowledge, Ahmed does not have another job lined up post his departure tomorrow.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,000+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Am­gen tops cost watch­dog's price gougers list based on 'un­sup­port­ed' in­creas­es for En­brel with­out mean­ing­ful da­ta

In a top 10 ranking of the most egregious price gougers from 2019, Amgen’s Enbrel topped US cost watchdog ICER’s naughty list with “unsupported” markups that added as much as $403 million to the nation’s drug spend during that time.

Price increases for some of pharma’s most popular drugs have long been a focus of consumer ire, but the industry has argued those increases are routine and meant to cover the cost of R&D innovation. Without meaningful guidance at the state or federal level, ICER looked to connect how much a drug had progressed in the clinic compared with its increase in both wholesale and net price in 2019.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,000+ biopharma pros reading Endpoints daily — and it's free.

News brief­ing: Five Prime fi­nal­izes PhI­II plans for gas­tric can­cer; AI di­ag­nos­tics-fo­cused Paige ex­pands staff

Five Prime Therapeutics has finalized a plan to take their comeback gastric cancer drug into late-stage studies.

The South San Francisco-based biotech released full Phase II data for bemarituzumab on Friday, which Five Prime said in November met all of its pre-specified efficacy endpoints in a topline readout. Now, the company is announcing it plans to launch a Phase III trial for the program in 2021. Following November’s readout, the future of bemarituzumab had not yet been finalized.