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.

Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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Nick Galakatos, Blackstone global head of life sciences

Nick Galakatos and the Black­stone team now have a record $4.6B to in­vest in bio­phar­ma, with a big fo­cus on push­ing com­pa­nies over the top

Nick Galakatos and his team at Blackstone Life Sciences have seen their biggest opportunities swell up in mostly established players who don’t have all the money they need to accomplish everything on the to-do list. And right now, with the industry booming, that’s a long list with some hefty needs.

The Blackstone team has neatly tied up the largest private fund ever raised in life sciences for making big dreams come true in biopharma. Late Thursday, Blackstone put out word that they had closed their highly anticipated fund with the projected $4.6 billion all in.

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Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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Gilead boasts of pos­i­tive remde­sivir da­ta on mor­tal­i­ty — but their analy­sis pro­vokes the skep­tics

Gilead is surging again off data that suggest its antiviral remdesivir might improve survival.

The new data come from an analysis Gilead conducted comparing the death rate and recovery time of patients in one of its remdesivir trials to a group of 800 patients “with similar baseline characteristics and disease severity” who received only standard-of-care around the same time. The result, they said, suggested that patients who received remdesivir had a 62% better chance at surviving than those who did not.

Andrew Kruegel, Kures president and co-founder (Columbia Tech Ventures via Vimeo)

Af­ter psilo­cy­bin and ke­t­a­mine, a new biotech comes along de­vel­op­ing a drug Scott Got­tlieb fought

Andrew Kruegel was six years into his chemistry work at Columbia University, when, one day in August 2016, he learned he might have only 30 days before the government made him destroy his research.

Kruegel had been studying kratom, a leaf long used in Southeast Asia as a stimulant or for pain. It had opioid-like properties, he found, but seemed to offer pain relief without the addictive potential or respiratory side effects of traditional opioids — a riddle that might help illuminate how human opioid receptors work.

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The home run count: The $100M+ mega-round boom in biotech in­spired a $7.3B feed­ing fren­zy — so far this year

Over the last 6 months there’s been a blizzard of money piling up drifts of the green stuff through the biotech landscape. And the forecast calls for more cash windfalls ahead.

Even as a global pandemic has killed more than half a million people, blighted economies and divided nations over the proper response, it’s also helped ignite an unprecedented burst of big-time investing. And not just in Covid-19 deals, as we’ve looked at before.

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Atul Deshpande, Harbour BioMed chief strategy officer & head, US operations (Harbour BioMed)

An­oth­er biotech IPO set-up? Multi­na­tion­al biotech leaps from round to round, scoop­ing up cash at a blis­ter­ing pace

A short four months after announcing a $75 million haul in Series B+ fundraising, the multinational biotech Harbour BioMed pulled in another round of investments and eclipsed the nine-digit mark in the process.

Harbour completed its Series C financing, the company announced Thursday morning, raising $102.8 million and bringing its total investment sum to over $300 million since its founding in late 2016. The biotech plans to use the money to transition early-stage candidates from the discovery phase, fund candidates already in the clinic, and prep late-stage candidates for commercialization.

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Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

A new study points to $6.5B in pub­lic sup­port build­ing the sci­en­tif­ic foun­da­tion of Gilead­'s remde­sivir. Should that be re­flect­ed in the price?

By drug R&D standards, Gilead’s move to repurpose remdesivir for Covid-19 and grab an emergency use authorization was a remarkably easy, low-cost layup that required modest efficacy and a clean safety profile from just a small group of patients.

The drug OK also arrived after Gilead had paid much of the freight on getting it positioned to move fast.

In a study by Fred Ledley, director of the Center for Integration of Science and Industry at Bentley University in Waltham, MA, researchers concluded that the NIH had invested only $46.5 million in the research devoted to the drug ahead of the pandemic, a small sum compared to the more than $1 billion Gilead expected to spend getting it out this year, all on top of what it had already cost in R&D expenses.

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Hal Barron, GSK

Win or lose on the mar­ket­ing OK, the FDA just gunned down GSK’s bright hopes for their BC­MA ther­a­py

The FDA’s ODAC — the Oncologic Drugs Advisory Committee — has a well-known bias in favor of adding new cancer drugs to the market, even if efficacy is at best marginal and serious safety issues demand careful management.

Doctors want as many arrows in their quiver as they can get. And when patients are dying after failing multiple drugs, why not give it a go one more time?

GlaxoSmithKline, though, is about to test out how their new BCMA antibody drug conjugate belantamab mafodotin can do after being mauled in an in-house FDA review, ahead of the Tuesday expert panel discussion. Even if the agency goes ahead with an expected green light, this drug will likely be constrained to a small niche — icing any plans they may have for making waves in oncology anytime soon.

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