No­van’s shares in melt­down fol­low­ing "dis­cor­dant" PhI­II stud­ies of a new ac­ne drug

Nathan Stasko, No­van

Of­fi­cial­ly, No­van $NOVN put out some mixed da­ta from two Phase III stud­ies of their lead drug for ac­ne, with one suc­cess and one fail­ure. But even the pos­i­tive da­ta from one tri­al failed to stand out from the con­trol arm in a ma­jor way, putting this com­pa­ny un­der a cloud.

Its stock plunged 80% this morn­ing.

On the up side, in­ves­ti­ga­tors say that SB204 hit all three co-pri­ma­ry end­points for NI-AC302, with sig­nif­i­cant – though far from im­pres­sive – re­sults for re­duc­ing the num­ber of le­sions and ac­ne clear­ance. Here are the num­bers, for both stud­ies:

•The ab­solute change from base­line in the num­ber of non-in­flam­ma­to­ry le­sions in NI-AC301 was -15.4 for SB204 and -13.4 for ve­hi­cle (p=0.030), and in NI-AC302 was -14.9 for SB204 and -12.3 for ve­hi­cle (p=0.001).

•The ab­solute change from base­line in the num­ber of in­flam­ma­to­ry le­sions in NI-AC301 was -12.1 for SB204 and -11.1 for ve­hi­cle (p=0.114), and in NI-AC302 was -12.9 for SB204 and -10.6 for ve­hi­cle (p<0.001).

•The pro­por­tion of pa­tients with IGA suc­cess in NI-AC301 was 13.4% for SB204 and 13.8% for ve­hi­cle (p=0.866), and in NI-AC302 was 18.9% for SB204 and 14.3% for ve­hi­cle (p=0.032).

A to­tal of 2,639 pa­tients ages 9 and old­er with mod­er­ate to se­vere ac­ne were en­rolled across a to­tal of 110 sites in the Unit­ed States.

The sec­ondary end­points looked quite sim­i­lar, leav­ing Mor­risville, NC-based No­van count­ing its cash. There’s enough mon­ey on hand to make it through the end of the year, when it’s hop­ing to have some bet­ter da­ta from an up­com­ing read­out on an an­ti-fun­gal pro­gram.

No­van raised $45 mil­lion with its IPO last fall, ear­mark­ing the mon­ey for an NDA for this drug, which it billed as the first new chem­i­cal en­ti­ty to come along for ac­ne in 20 years. Those plans may well have to change now. The biotech end­ed the day yes­ter­day with a mar­ket cap of $298 mil­lion.

“While we are pleased with the re­sults of the NI-AC302 tri­al that met the reg­u­la­to­ry re­quire­ment for sta­tis­ti­cal­ly sig­nif­i­cant ef­fi­ca­cy of SB204, we are dis­ap­point­ed with the dis­cor­dant re­sults of NI-AC301. Our team has not yet re­ceived the full da­ta set and we in­tend to pro­vide an up­date on the SB204 pro­gram af­ter our com­plete analy­sis,” said Nathan Stasko, PhD, Pres­i­dent and CEO of No­van. “De­spite these dis­cor­dant re­sults, we be­lieve in the po­ten­tial of ni­tric ox­ide’s mul­ti­ple, well-doc­u­ment­ed mech­a­nisms of ac­tion and the da­ta we have re­cent­ly gen­er­at­ed for our SB206 an­ti-vi­ral and SB414 an­ti-in­flam­ma­to­ry prod­uct can­di­dates. We con­tin­ue to look for­ward to near term clin­i­cal re­sults from our SB208 an­ti-fun­gal pro­gram in the sec­ond quar­ter of 2017 and ad­vanc­ing our pipeline of in­no­v­a­tive ther­a­pies for pa­tients suf­fer­ing from skin dis­eases.”

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls



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