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.

A New Fron­tier: The In­ner Ear

What happens when a successful biotech venture capitalist is unexpectedly diagnosed with a chronic, life-disrupting vertigo disorder? Innovation in neurotology.

That venture capitalist was Jay Lichter, Ph.D., and after learning there was no FDA-approved drug treatment for his condition, Ménière’s disease, he decided to create a company to bring drug development to neurotology. Otonomy was founded in 2008 and is dedicated to finding new drug treatments for the hugely underserved community living with balance and hearing disorders. Helping patients like Jay has been the driving force behind Otonomy, a company heading into a transformative 2020 with three clinical trial readouts: Phase 3 in Ménière’s disease, Phase 2 in tinnitus, and Phase 1/2 in hearing loss. These catalysts, together with others in the field, highlight the emerging opportunity in neurotology.
Otonomy is leading the way in neurotology
Neurotology, or the treatment of inner ear neurological disorders, is a large and untapped market for drug developers: one in eight individuals in the U.S. have moderate-to-severe hearing loss, tinnitus or vertigo disorders such as Ménière’s disease.1 With no FDA-approved drug treatments available for these conditions, the burden on patients—including social anxiety, lower quality of life, reduced work productivity, and higher rates of depression—can be significant.2, 3, 4

Joe Jimenez, Getty

Ex-No­var­tis CEO Joe Jimenez is tak­ing an­oth­er crack at open­ing a new chap­ter in his ca­reer — and that in­cludes a new board seat and a $250M start­up

Joe Jimenez is back.

The ex-CEO of Novartis has taken a board seat on Century Therapeutics, the Versant and Bayer-backed startup focused on coming up with a brand new twist on cell therapies for cancer — a field where Jimenez made his mark backing the first personalized CAR-T approved for use.

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Can we make the an­tibi­ot­ic mar­ket great again?

The standard for-profit model in drug development is straightforward. Spend millions, even billions, to develop a medicine from scratch. The return on investment (and ideally a tidy profit) comes via volume and/or price, depending on the disease. But the string of big pharma exits and slew of biotech bankruptcies indicate that the model is sorely flawed when it comes to antibiotics.

The industry players contributing to the arsenal of antimicrobials are fast dwindling, and the pipeline for new antibiotics is embarrassingly sparse, the WHO has warned. Drugmakers are enticed by greener pastures, compared to the long, arduous and expensive path to antibiotic approval that offers little financial gain as treatments are typically priced cheaply, and often lose potency over time as microbes grow resistant to them.

Top Har­vard chemist caught up in FBI’s 'T­hou­sand Tal­ents' drag­net, ac­cused of ly­ing about Chi­nese con­nec­tions, pay

The FBI’s probe into the alleged theft of R&D secrets by Chinese authorities has drawn Harvard’s top chemist into its net.

The agency accused Charles M. Lieber, who chairs the university’s chemistry and chemical biology department, with lying about his involvement in China’s Thousand Talents campaign, which was established as a way of drawing in innovators from around the world. And the scientist, 60, was charged with making false statements about his ties to China.

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Eye­ing a trio of tri­al ini­ti­a­tions, Jim Wilson's gene ther­a­py start­up woos Bruce Gold­smith from Deer­field as CEO

Passage Bio — Jim Wilson’s self-described “legacy company” — has wooed a seasoned biotech executive to steer the clinical entry of its first three gene therapy programs.

Bruce Goldsmith jumps to the helm of Passage after a brief CEO stint at Civetta, a cancer-focused startup he helped launch while a venture partner at Deerfield. He takes over from OrbiMed partner and interim chief Stephen Squinto, who will now lead the R&D team.

The FTC and New York state ac­cuse Mar­tin Shkre­li of run­ning a drug mo­nop­oly. They plan to squash it — and per­ma­nent­ly ex­ile him

Pharma bro Martin Shkreli was jailed, publicly pilloried and forced to confront some lawmakers in Washington riled by his move to take an old generic and move the price from $17.50 per pill to $750. But through 4 years of controversy and public revulsion, his company never backed away from the price — left uncontrolled by a laissez faire federal policy on a drug’s cost.

Now the FTC and the state of New York plan to pry his fingers off the drug once and for all and open it up to some cheap competition. And their lawsuit is asking that Shkreli — with several years left on his prison sentence — be banned permanently from the pharma industry.

UP­DAT­ED: Ac­celeron res­ur­rects block­buster hopes for so­tater­cept with pos­i­tive PhII — and shares rock­et up

Acceleron $XLRN says that its first major trial readout of 2020 is a success.

In a Phase II study of 106 patients with pulmonary arterial hypertension (PAH), Acceleron’s experimental drug sotatercept hit its primary endpoint: a significant reduction in pulmonary vascular resistance. The drug also met three different secondary endpoints, including the 6-minute walking test.

“We’re thrilled to report such positive topline results from the PULSAR trial,” Acceleron CEO Habib Dable said in a statement. The company said in a conference call they plan on discussing a Phase III trial design with regulators.

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Short at­tack­er Sahm Ad­ran­gi draws crosshairs over a fa­vorite of Sanofi’s new CEO — with PhII da­ta loom­ing

Sahm Adrang Kerrisdale

Kerrisdale chief Sahm Adrangi took a lengthy break from his series of biotech short attacks after his chief analyst in the field pulled up stakes and went solo. But he’s making a return to drug development this morning, drawing crosshairs over a company that’s one of new Sanofi CEO Paul Hudson’s favorite collaborators.

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Amber Saltzman (Ohana)

Flag­ship's first ven­ture of 2020 is out, and it's all about sperm

A couple years ago, Amber Salzman got a call as she was returning East full-time after a two-year stint running a gene therapy company in California.

It was from someone at Flagship Pioneering, the deep-pocketed biotech venture firm. They had a new company with a new way of thinking about sperm. It had been incubating for over a year, and now they wanted her to run it.

“It exactly fit,” Salzman told Endpoints News. “I just thought I had to do something.”