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.

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.