Si­en­na con­cedes fail­ure in piv­otal ac­ne tri­al — will the laser-man­aged ther­a­py work in hair re­duc­tion?

Si­en­na Bio­phar­ma­ceu­ti­cals’ first for­ay in­to piv­otal tri­als is a bust.

The West­lake Vil­lage, CA biotech re­port­ed that its lead ther­a­py, SNA-001, flunked two sep­a­rate tri­als de­signed to test its ef­fi­ca­cy when man­aged by laser tech. Shares $SNNA are down 20% in pre-mar­ket trad­ing.

Fred­er­ick Bed­ding­field

In­stead of sep­a­rat­ing the pa­tients in­to drug and con­trol arms, re­searchers adopt­ed a split-face method in which each side of the pa­tient’s face got treat­ed with laser and ei­ther SNA-001 or ve­hi­cle. Both treat­ments re­duced ac­ne le­sion count from base­line — the pri­ma­ry end­point — to a sim­i­lar ex­tent, and the dif­fer­ences were not sig­nif­i­cant in ei­ther the 810 nm laser (p=0.663) or 1064 nm laser (p=0.411) tri­al, which re­cruit­ed 78 and 89 sub­jects re­spec­tive­ly.

The p-val­ues were sim­i­lar­ly unim­pres­sive for the sec­ondary end­points.

“These da­ta are clear and un­am­bigu­ous,” CEO Fred­er­ick Bed­ding­field said in a con­fer­ence call, not­ing that his team did every­thing right, run­ning a clean clin­i­cal pro­gram in search of def­i­nite out­comes. Sub­set analy­ses aren’t like­ly to hap­pen.

While the ex­ecs are wait­ing for the re­sults from a third tri­al com­ing in by the end of the year to make a de­ci­sion, Bed­ding­field ad­mit­ted the prob­a­bil­i­ty of suc­cess there “cer­tain­ly seems low­er” now.

He was quick to add that ac­ne has been con­sid­ered their small­est op­por­tu­ni­ty for SNA-001: The re­duc­tion of un­want­ed light-pig­ment­ed hair — with piv­otal read­out ex­pect­ed in Q4 — works via a sim­pler mech­a­nism, re­quires a sim­pler pro­ce­dure, and of­fers a low­er hur­dle for show­ing ef­fi­ca­cy.

Si­en­na, which counts Robert Nelsen at Arch Ven­tures and Part­ner Fund Man­age­ment among its in­vestors, com­plet­ed its $65 mil­lion IPO around this time last year boast­ing a two-pronged de­vel­op­ment strat­e­gy. SNA-001 came out of their top­i­cal pho­topar­ti­cle ther­a­py plat­form; on the oth­er side of the pipeline they have SNA-120 and SNA-125, two trans­der­mal ther­a­pies for in­flam­ma­to­ry skin dis­eases and pru­ri­tus they picked up from the ac­qui­si­tion of Cre­abilis.

Cash on hand is suf­fi­cient, Bed­ding­field said, to get the com­pa­ny through all of their da­ta read­outs, in­clud­ing a Phase II pru­ri­tus and pso­ri­a­sis tri­al for SNA-120 and first-in-hu­man stud­ies for the JAK3/Tr­kA in­hibitor SNA-125.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic so far to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Covid-19 roundup: EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund; Bei­jing ar­rests ex-Bio­gen staffer who flew while in­fect­ed

For months now, the US government has doled out unprecedented grants to vaccine developers in hopes of speeding the completion of a Covid-19 candidate, even if that meant putting hundreds of millions or billions behind efforts that ultimately failed. Now, the European Union may do the same.

The EU is planning to use a $2.7 billion rainy day fund to make advance purchases of vaccine candidates, Reuters reports. The news comes a day after the Trump Administration reportedly settled on the five finalists for its Operation Warp Speed, all of whom will get significant funding and other US assistance to finish testing and scale up their vaccine candidates.

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New safe­ty da­ta ex­pose po­ten­tial weak­ness as Pfiz­er's abroc­i­tinib takes on Dupix­ent in eczema

Last September, when Pfizer celebrated positive data from a second Phase III study of abrocitinib, many watchers applauded the efficacy but were still waiting to see whether the JAK1 inhibitor is “safe enough to be a formidable competitor to Dupixent,” the clear leader in the atopic dermatitis field. The full slate of safety data are now out and, according to one analyst, the answer is: probably not.

José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

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Doug Throckmorton speaks via video conference to the Senate Finance Committee, June 2, 2020 (Andrew Caballero-Reynolds, AP Images)

FDA de­fends its over­sight of for­eign drugs amid Sen­ate, GAO crit­i­cism

During a Senate Committee on Finance hearing Tuesday, officials from the FDA responded to criticism from senators and a new report from the Government Accountability Office (GAO) on its oversight of foreign drug manufacturers.

The hearing follows FDA’s move to halt most foreign inspections in March as a result of the coronavirus disease (COVID-19) pandemic.

Much of the criticism centered on the agency’s practice of giving foreign facilities advanced notice of inspections while most domestic surveillance inspections are unannounced, as well as US reliance on foreign drug manufacturing.

UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.