Vanda's VQW-765 Fails Phase III Social Anxiety Trial
Vanda Pharmaceuticals reported that its Phase III study of VQW-765 for acute anxiety in social anxiety disorder did not meet its primary endpoint. The trial randomized 546 adults and tested a single oral dose against placebo during a psychosocial stress test. VQW-765 was safe and well tolerated, but the primary and key secondary distress measures showed no statistically significant difference from placebo.
Vanda’s Phase III Study 3201 enrolled 546 U.S. adults aged 18–65 with social anxiety disorder and high baseline scores on two anxiety scales. Participants took one oral dose of VQW-765 or placebo, then underwent the Trier Social Stress Test, which includes preparation and a no-feedback presentation.
The primary measure was female participants’ distress during the test’s performance phase, rated 0–100. VQW-765 did not separate from placebo; the full-population secondary measure also missed. VQW-765, an α7-nAChR partial agonist licensed from Novartis, was safe and well tolerated, and the program is paused pending further analysis.
Count: First para: Vanda’s(1) Phase(2) III(3) Study(4) 3201(5) enrolled(6) 546(7) U.S.(8) adults(9) aged(10) 18–65(11) with(12) social(13) anxiety(14) disorder(15) and(16) high(17) baseline(18) scores(19) on(20) two(21) anxiety(22) scales(23). Participants(24) took(25) one(26) oral(27) dose(28) of(29) VQW-765(30) or(31) placebo,(32) then(33) underwent(34) the(35) Trier(36) Social(37) Stress(38) Test,(39) which(40) includes(41) preparation(42) and(43) a(44) no-feedback(45) presentation(46). Good 46.
Second: The(1) primary(2) measure(3) was(4) female(5) participants’(6) distress(7) during(8) the(9) test’s(10) performance(11) phase,(12) rated(13) 0–100.(14) VQW-765(15) did(16) not(17) separate(18) from(19) placebo;(20) the(21) full-population(22) secondary(23) measure(24) also(25) missed.(26) VQW-765,(27) an(28) α7-nAChR(29) partial(30) agonist(31) li
... No extra. Need plain text. Ensure no markdown? Fine. Potential issue: "under 120 words total" for expanded. We have 103. Good. "2 short paragraphs" yes. "under 90 words" context 62. Good. Need ensure no copying source phrasing. We have "Trier Social Stress Test" proper. "social anxiety disorder" proper. "α7-nAChR partial agonist" technical. "on hold pending further analysis" changed to "paused while the full dataset is reviewed." Let's update final expanded second paragraph: "VQW-765, an α7-nAChR partial agonist obtained from Novartis under license, raised no safety or tolerability concerns; the program is paused while the full dataset is reviewed." Count: VQW-7651, an2 α7-nAChR3 partial4 agonist5 obtained6 from7 Novartis8 under9 license10, raised11 no12 safety13 or14 tolerability15 concerns16; the17 program18 is19 paused20 while21 the22 full23 dataset24 is25 reviewed26. Total second para: The1 main2 measure3 was4 female5 participants’6 distress7 during8 the9 performance10 phase1