Watch out be­low: Der­mi­ra ax­es ac­ne drug af­ter a cat­a­stroph­ic PhI­II fail­ure

Der­mi­ra set it­self up for one of the big stock $DERM cat­a­lysts of Q1 with its Phase III ac­ne stud­ies for DRM01. And it got knocked down — hard — Mon­day morn­ing as it re­port­ed the late-stage pro­gram had suf­fered a cat­a­stroph­ic fail­ure.

Tom Wig­gans, Der­mi­ra

The pri­ma­ry end­points for the two stud­ies showed that the re­sults for the drug close­ly mir­rored the place­bo arm, leav­ing the com­pa­ny with noth­ing to show for it. Der­mi­ra ex­ecs say they will now close down the pro­gram and move on.

That wasn’t what the stock touts want­ed to hear. Shares were oblit­er­at­ed in the rout, drop­ping more than 70%.

DRM01 is de­signed to re­duce the pro­duc­tion of se­bum, find­ing a new way to treat the skin con­di­tion by pre­vent­ing the oily buildup that trig­gers an out­break. That prospect — though hard­ly a tough un­met med­ical need in the biotech world — whipped up con­sid­er­able spec­u­la­tive move­ment on the stock price.

Some an­a­lysts quick­ly ac­knowl­edged their bad sig­nals. Umer Raf­fat at Ever­core ISI not­ed:

This is a name that I had flagged as car­ry­ing 65% prob­a­bil­i­ty go­ing in­to the Ph 3 tri­al based on our pri­or analy­sis + the con­sis­ten­cy of DRM01’s da­ta from ph2a + 2b… clear­ly that didn’t pan out.  I clear­ly stand cor­rect­ed.

Fail­ure did not come cheap for Der­mi­ra, which re­cruit­ed 1,500 pa­tients for the stud­ies. But the com­pa­ny does have oth­er drugs to turn to, in­clud­ing DRM04, which is sup­posed to re­duce sweat­ing in kids. The biotech al­so bought le­brik­izum­ab from Roche af­ter the phar­ma gi­ant pro­duced some dis­ap­point­ing da­ta for the drug, now be­ing stud­ied for atopic der­mati­tis.

“We are sur­prised and ex­treme­ly dis­ap­point­ed by the re­sults of the Phase III pro­gram,” said Tom Wig­gans, chair­man and chief ex­ec­u­tive of­fi­cer of Der­mi­ra. “This is dis­ap­point­ing not on­ly for the com­pa­ny, but al­so for pa­tients who are liv­ing with this con­di­tion and der­ma­tol­o­gists who have been look­ing for nov­el ther­a­pies to treat them.”

UP­DAT­ED: In a stun­ning turn­around, Bio­gen says that ad­u­canum­ab does work for Alzheimer's — but da­ta min­ing in­cites con­tro­ver­sy and ques­tions

Biogen has confounded the biotech world one more time.

In a stunning about-face, the company and its partners at Eisai say that a new analysis of a larger dataset on aducanumab has restored its faith in the drug as a game-changer for Alzheimer’s and, after talking it over with the FDA, they’ll now be filing for an approval of a drug that had been given up for dead.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,800+ biopharma pros reading Endpoints daily — and it's free.

David Liu, Liu Group

David Liu un­veils newest ad­vance­ment in CRISPR tech: Prime edit­ing

The researcher behind base-editing is out with what some scientists are hailing as the biggest advancement in CRISPR technology since that 2016 breakthrough: “prime editing.” The new molecular gadget is capable of erasing any base pair and stenciling in another and cutting or adding long segments of DNA without breaking both strands of the helix.

David Liu, base editing pioneer and founder of Beam Therapeutics, published the findings in Nature alongside Andrew Anzalone. They estimated that the breakthrough “in principle” puts 89% of human diseases in purview — although experts cautioned that human therapies were a long way off.

Vas Narasimhan. Getty Images

Failed PhI­II fe­vip­iprant tri­als pour more cold wa­ter on No­var­tis' block­buster R&D en­gine — and spread the chill to a high-pro­file biotech

Back in July, during an investor call where Novartis execs ran through an upbeat assessment of their Q2 performance, CEO Vas Narasimhan and development chief John Tsai were pressed to predict which of the two looming Phase III readouts — involving cardio drug Entresto and asthma therapy fevipiprant, respectively — had a higher likelihood of success. Tsai gave the PARAGON-HF study with Entresto minimally better odds, but Narasimhan emphasized that their strategy of giving fevipiprant to more severe patients gave them confidence.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,800+ biopharma pros reading Endpoints daily — and it's free.

Bhaskar Chaudhuri. Frazier Healthcare Partners

Fra­zier Health­care Part­ner­s' der­ma­tol­ogy up­start at­tracts a mar­quee syn­di­cate, $94M+ for 'in-be­tween' top­i­cal drug

For the past three years Frazier Healthcare Partners’ Bhaskar Chaudhuri has been carefully and quietly grooming Arcutis Therapeutics, a new dermatology play he co-founded to deliver topical formulations of well-known drugs. Now that the biotech is poised to enter Phase III, he’s being joined by a marquee syndicate for its $94.5 million Series C.

HBM Healthcare Investments, Vivo Capital, BlackRock, Omega Funds, Pivotal BioVentures, and Goldman Sachs jumped on board, joining Bain Capital Life Sciences, OrbiMed and RA Capital Management in backing Arcutis’ lead topical cream for plaque psoriasis.

A new com­pa­ny en­ters the Tec­fidera fight, of­fer­ing to kill two birds

The remedy for the most common side effect for one of the most common multiple sclerosis drugs is simple: aspirin.

Taking aspirin with Biogen’s Tecfidera will reduce the flush, a sometimes painful form of red skin irritation, many patients experiences. The problem is that the aspirin has to be taken at least 30 minutes before Tecfidera, turning a simple twice-a-day, one-dose oral drug into a staggered two-drug regimen.

UP­DAT­ED: The FDA sets a reg­u­la­to­ry speed record, pro­vid­ing a snap OK for Ver­tex's break­through triplet for cys­tic fi­bro­sis

The FDA has approved Vertex’s new triplet for cystic fibrosis at a record-setting speed.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,800+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Bris­tol-My­ers makes Op­di­vo pitch for front­line lung can­cer with open la­bel PhI­II study

Despite a head start, when Bristol-Myers Squibb and its pioneering checkpoint inhibitor Opdivo suffered a key lung cancer setback in 2016, they found themselves relegated to the backseat as Merck’s Keytruda seized the wheel on the road to immunotherapy stardom. Bristol-Myers has since suffered blow after blow in its quest to take a big slice of the lucrative market, peppered with some small successes. On Tuesday, the New Jersey drugmaker touted positive data from a Phase III open-label study in a bid to carve itself a piece of the frontline lung cancer market.

Take­da tees up $420M deal for celi­ac an­ti­dote, con­tin­u­ing R&D re­fo­cus

Sometime in the 1st century AD, a patient presented to Arataeus looking like a varicose ghost. He was “emaciated and atrophied, pale, feeble and incapable of performing any of his accustomed works,” the Greek physician wrote, with hollow temples and huge veins running all over his body.

A dysfunctional digestive system, Arataeus concluded – an imbalance he attributed to a “heat” deficiency in a system he and other Greeks regarded as functioning similarly to an oven – and coined a term: coeliac disease, after the Greek word for abdomen.

CD47 play­er Tril­li­um chops dis­cov­ery ef­forts and 40% of staff; Brii Bio inks deal to bring an­tibi­otics to Chi­na

→ One month into his tenure at Canadian microcap biotech Trillium, Jan Skvarka is bringing out the ax as he sorts out the development plans for its CD47 drugs. The restructuring will see the discovery research unit nixed and the headcount will be reduced by 40% (from 43 to 26), reducing the burn rate from CDN$10 million to CDN$4-7 million per quarter. Meanwhile, the company will seek to partner out its preclinical STING agonist program, which it likely doesn’t have enough resources to tend to.