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Lundbeck has reported primary P-IIb (PROCEED) trial data assessing bocunebart (Lu AG09222, QM, SC or IV) vs PBO as a preventive treatment in pts with 1-4 prior preventive migraine treatment failures
In the IV group (n=429), bocunebart met its 1EP, reducing monthly migraine days over Wks. 1-12, with a mean reduction of 4.24 vs…
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Altimmune has reported 48wk. data from the P-IIb (IMPACT) trial assessing pemvidutide (1.2 or 1.8mg, SC, QW) vs PBO in 212 pts with MASH & fibrosis stages F2 or F3, with & without diabetes
Pemvidutide (1.8mg) showed a reduction in triglycerides by 23.7%, total cholesterol by 15.4%, BMI by 3kg/m², waist circumference by 5.3cm,…
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Mirum has reported global P-IIb (VISTAS) trial data evaluating volixibat (20mg, BID) vs PBO in 158 patients with cholestatic pruritus caused by PSC, incl. 111 pts in the primary analysis cohort with mod. to sev. itch & 47 pts in the secondary cohort with mild itch
In the primary cohort, volixibat met the 1EP,…
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Cue Biopharma has entered into an exclusive license agreement with Ascendant Health Sciences to develop, manufacture and commercialize Ascendant-221 for the treatment of allergic diseases
As per the deal, Cue will obtain global rights (excl. Greater China) to develop & commercialize Ascendant-221 in exchange for $15M upfront license fee, ~$676.5M in development, regulatory &…
Merck Initiates P-IIb/III (MALBEC) Trial of MK-8748 for Neovascular Age-Related Macular Degeneration
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Merck initiates the P-IIb/III (MALBEC) trial assessing MK-8748 (Tiespectus/EYE201) for the treatment of neovascular (wet) age-related macular degeneration (NVAMD)
The trial will assess the safety & efficacy of two intravitreal dose levels of MK-8748 vs aflibercept (2mg), with Q4W dosing initially for 3mos., then Q8W through Wk. 48, followed by individualized dosing intervals, with…
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ViiV Healthcare has reported 12mos. interim data from P-IIb (EMBRACE) trial assessing lotivibart (IV or SC, Q4M) + cabotegravir (CAB LA; IM, QM) vs SoC for the treatment of HIV
lotivibart + cabotegravir maintained viral suppression in 94% of lotivibart IV & 82% of SC recipients vs 88%, with confirmed virologic failure in 4%…
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J&J has reported the long-term data from the QUASAR LTE trial in pts with mod. to sev. active ulcerative colitis, showing lasting disease control for patients
The P-IIb/III (QUASAR) trial assessed Tremfya (IV induction: 200mg Q4W; SC maintenance: 100mg, Q8W or 200mg, Q4W) vs PBO in UC pts
At Wk. 140, ~89% completed treatment,…
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Teva & Sanofi have reported RELIEVE UCCD LTE study data evaluating duvakitug (450 or 900mg, SC, Q4W) in 130 pts with ulcerative colitis (UC) or Crohn’s disease (CD) following P-IIb (RELIEVE UCCD) induction study
Trial showed that at Wk. 44 of maintenance, 58% (900mg) & 47% (450mg) of UC pts achieved clinical remission per mMS,…
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Lundbeck has reported P-IIb (PROCEED) trial results evaluating bocunebart (SC/IV; QM for 3mos.) vs PBO in migraine patients with prior failure of 1-4 preventive therapies, with the IV arm randomizing 431 pts across 14 countries
Trial met its 1EP in the multiple IV dosing arm, showing a statistically significant reduction in monthly migraine days…
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Assessing PF’3944 (QW titration to QM) in obese/overweight pts without T2D, the trial randomized pts to Arm 1 (0.4mg QW/ 0.8mg QW/ 3.2mg QM), Arm 2 (0.8mg QW/ 3.2mg QM), Arm 3 (0.4mg QW/ 0.8mg QW/ 1.2mg QW/ 4.8mg QM), Arm 4 (0.6mg QW/ 1.2mg QW/ 4.8mg QM), or Arm 5 (PBO)
Trial met…

