Cri­net­ics re­veals pos­i­tive topline pri­ma­ry and sec­ondary end­point da­ta in PhI­II acromegaly tri­al

Cri­net­ics’ first of two Phase III tri­als in­ves­ti­gat­ing its drug pal­tuso­tine in acromegaly read out pos­i­tive topline da­ta Sun­day, with the drug hit­ting the pri­ma­ry end­point and all sec­ondary end­points, bol­ster­ing the com­pa­ny’s plans to file for an NDA next year.

Pal­tuso­tine, an oral, once-dai­ly se­lec­tive­ly tar­get­ed so­mato­statin re­cep­tor type 2 ag­o­nist, earned a p-val­ue of p<0.0001 on the pri­ma­ry end­point in­ves­ti­gat­ing the pro­por­tion of par­tic­i­pants tak­ing pal­tuso­tine who main­tained an in­sulin-like growth fac­tor 1 (IGF-1) lev­el less than or equal to 1.0 times the up­per lim­it of nor­mal. In the PATHFN­DR-1 study, 83% of pa­tients on Cri­net­ics’ drug main­tained the IGF-1 lev­els com­pared to just 4% on place­bo.

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