Contrafect Corp (CFRX)

[trickledownfacists]

FDA grants ‘break­through’ sta­tus to an­tibi­ot­ic al­ter­na­tive as Con­tra­Fect rush­es to join fight against su­per­bug

Amber Tong

Methicillin-resistant Staph aureus (Shutterstock)

An ex­per­i­men­tal drug that promis­es to be the first an­ti-in­fec­tive agent to prove su­pe­ri­or to van­comycin — an an­tibi­ot­ic ap­proved in 1958 — has notched the FDA’s “break­through” sta­tus.

Roger Pomer­antz
Con­tra­Fect said the des­ig­na­tion was based on Phase II da­ta in which exe­ba­case was test­ed against a su­per­bug known as me­thi­cillin-re­sis­tant Staph au­reus, or MR­SA. In a sub­group analy­sis, the clin­i­cal re­spon­der rate at day 14 was 42.8% high­er than that among those treat­ed with stan­dard of care, the com­pa­ny said (p=0.010).

The 21% re­duc­tion in 30-day all-cause mor­tal­i­ty, how­ev­er, was not sta­tis­ti­cal­ly sig­nif­i­cant with p=0.056.

Demon­strat­ing su­pe­ri­or­i­ty marks a first for the MR­SA field, em­pha­sized Roger Pomer­antz, who jumped from Seres to be­come CEO for Con­tra­Fect last April. Al­ler­gan’s Dal­vance, a struc­tur­al rel­a­tive to van­comycin, was ap­proved based on non-in­fe­ri­or­i­ty.

Con­tra­Fect is now con­duct­ing a piv­otal Phase III study to ex­am­ine exe­ba­case’s ef­fi­ca­cy in all in­fec­tions caused by Staph au­reus, in­clud­ing right-sided en­do­cardi­tis.

Cara Cassi­no
“Based on our in­ter­ac­tions with the FDA re­gard­ing stream­lined de­vel­op­ment of exe­ba­case, this sin­gle Phase 3 study, in ad­di­tion to the full pack­age of da­ta gen­er­at­ed to date, may serve as the ba­sis of a Bi­o­log­ics Li­cense Ap­pli­ca­tion for FDA re­view and po­ten­tial ap­proval of exe­ba­case,” CMO Cara Cassi­no said in a state­ment.

MR­SA, which com­pris­es a group of Gram-pos­i­tive bac­te­ria, can cause in­fec­tions in the skin, the heart, the res­pi­ra­to­ry sys­tem, bone and joint, and even the cen­tral ner­vous sys­tem.

Michael Messinger
Tak­ing a page from bac­te­rio­phages — virus­es that in­fect bac­te­ria — Con­tra­Fect’s drug is a cell wall hy­dro­lase en­zyme, or lysin, that in­duces bac­te­r­i­al death by punc­tur­ing the cell wall. Its in­ven­tor, Vin­cent Fis­chet­ti of Rock­e­feller Uni­ver­si­ty, calls it an an­tibi­ot­ic al­ter­na­tive.

The com­pa­ny fore­casts a $700 mil­lion mar­ket for the MR­SA bac­teremia in­di­ca­tion pro­vid­ed that exe­ba­case de­liv­ers in Phase III and gets the su­pe­ri­or­i­ty la­bel, CFO Michael Messinger told End­points News. They are al­so gun­ning for an ex­pand­ed la­bel cov­er­ing all Staph au­reus.

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