Aptinyx's lead drug makes cut in small fi­bromyal­gia tri­al, set­ting the stage for larg­er chron­ic pain study

Four months ago, its lead drug fell short of hit­ting sta­tis­ti­cal sig­nif­i­cance in a di­a­bet­ic pe­riph­er­al neu­ropa­thy (DPN) study. On Mon­day, the new­ly-pub­lic Aptinyx re­vealed the ex­per­i­men­tal treat­ment has scored in a small mid-stage fi­bromyal­gia tri­al, paving the way for a larg­er study to be­gin in the sec­ond half of this year.

The drug — dubbed NYX-2925 — was de­vel­oped by the Evanston, IL-based biotech $AP­TX that went pub­lic last Ju­ly bank­ing on its ap­proach to mod­u­late NM­DA re­cep­tors, which are cru­cial to brain and ner­vous sys­tem func­tion.

Fi­bromyal­gia pa­tients suf­fer wide­spread mus­cu­loskele­tal pain ac­com­pa­nied by fa­tigue, sleep, mem­o­ry and mood is­sues — and re­searchers sus­pect that the dis­or­der am­pli­fies painful sen­sa­tions by af­fect­ing the way the brain process­es pain sig­nals. Fi­bromyal­gia is al­so con­sid­ered to be as­so­ci­at­ed with in­creased over­all lev­els of glu­ta­mate/glu­t­a­mine (Glx) in cer­tain brain re­gions, which is un­der­stood to cor­re­spond with en­hanced pain sever­i­ty.

NYX-2925 was test­ed in a 23-pa­tient sin­gle-blind study. In a se­quen­tial man­ner, but blind­ed to the pa­tient, all pa­tients re­ceived dai­ly dos­es of place­bo, 20 mg dose of the drug and 200 mg NYX-2925 for two weeks each. Over the course of the tri­al, pa­tients were test­ed for key brain ac­tiv­i­ty and neu­ro­chem­istry bio­mark­ers known to be as­so­ci­at­ed with per­cep­tion and pro­cess­ing of cen­tral­ized chron­ic pain.

Com­pared to place­bo, ad­min­is­tra­tion of NYX-2925 re­sult­ed in sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tions of Glx lev­els in these key pain-reg­u­lat­ing brain re­gions, and the use of the drug al­so re­sult­ed in re­duced con­nec­tiv­i­ty be­tween brain re­gions that are known to be as­so­ci­at­ed with the pro­cess­ing of cen­tral­ized chron­ic pain, Aptinyx said, adding that the pa­tient-re­port­ed sec­ondary end­points were al­so met. 

Daniel Clauw

“The re­sults with NYX-2925…com­pare very fa­vor­ably with the ef­fects of ap­proved fi­bromyal­gia drug treat­ments we pre­vi­ous­ly eval­u­at­ed in sep­a­rate and sim­i­lar stud­ies,” said Daniel Clauw, pro­fes­sor of med­i­cine at the Uni­ver­si­ty of Michi­gan and an in­ves­ti­ga­tor in the study. “(I)t is no­table that, de­spite the small num­ber of pa­tients in the study, the ef­fects on these clin­i­cal as­sess­ments of pain and oth­er symp­toms were al­so sta­tis­ti­cal­ly sig­nif­i­cant.”

Even though the DPN study did not meet its pri­ma­ry end­point, the com­pa­ny claims cer­tain dos­es of the drug did con­fer a nu­mer­i­cal im­prove­ment. Aptinyx says it plans to be­gin fol­low-up stud­ies in DPN and fi­bromyal­gia lat­er this year.

So­cial im­age: Shut­ter­stock

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Novartis CEO Vas Narasimhan [via Bloomberg/Getty]

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