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Arrowhead has reported P-I/IIa (ARO-DIMER-PA-1001) study data assessing the safety, tolerability, PK, PD, & effects on LDL-C and TGs of single-dose (part 1) & multiple doses (part 2) of ARO-DIMER-PA in ~78 adults with mixed hyperlipidemia
ARO-DIMER-PA single doses produced dose-dependent mean maximal reductions in serum PCSK9 of 72% & APOC3 of 88%, along with…
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The P-II (QUINTESSENTIAL) trial assessed arlocabtagene autoleucel (arlo-cel) in r/r MM pts, who were previously treated with an immunomodulatory inhibitor, a proteasome inhibitor, an anti-CD38 therapy & a BCMA-targeted therapy
The trial met its 1EP, showing improvement in ORR, & its key 2EP of CRR in the above-mentioned pts who had previously received ≥4L…
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Teva has reported topline P-IIa trial results assessing TEV ‘408 in adults with celiac disease on a gluten-free diet (GFD) with minimal intestinal damage; additional analyses are underway
The trial met its 1EP, showing prevention of gluten-induced intestinal damage at Wk. 8 following a single SC dose & improving Vh:Cd ratio, with least squares (LS)…
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The P-II/III (ALKIVIA) trial assessed Vyvgart Hytrulo (SC, QW) vs PBO PH20 (SC) for the treatment of pts (n=264) with autoimmune myositis across immune-mediated necrotizing myopathy (IMNM), dermatomyositis (DM) & PM
The study met its 1EP, with Vyvgart Hytrulo delivering a 15.4-point greater improvement in mean TIS at Wk. 52 in IMNM & DM pts…
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Definium has reported topline P-III (Voyage) trial results assessing DT120 (lysergide, Orally Disintegrating Tablet, 100µg; n=107) vs PBO (n=107) in 214 adults with GAD
Voyage met its 1EP, with DT120 improving HAM-A scores at Wk. 12 (-11.6 vs -6.2). Efficacy emerged by Day 2 & was sustained through all post-baseline timepoints in Part A
Key…
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P-II trial, conducted by Belenos’partner Keymed Biosciences, assessed BEL512 (SC; 300mg, Q12W/Q24W or 600mg, Q24W) vs PBO, both on top of intranasal corticosteroid (QD), in 120 Chinese pts with CRSwNP with NPS of ≥5 (≥2 polyps/nostril) & a NCS of 2-3
Trial met its 1 & 2EPs, with the BEL512 showing statistically significant improvements…
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Silence has reported topline P-II (SANRECO) trial results assessing divesiran (6mg/kg, SC, Q6W or Q12W) vs PBO in 48 phlebotomy-dependent patients with polycythemia vera (PV); P-III PV trial for Q12W dosing to initiate in H1’27
Trial met its 1EP, with significantly more PV pts responding to divesiran vs PBO (88% vs 19%). Response was…
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CSL has reported topline P-IIIb results evaluating Andembry (garadacimab-gxii) in children aged 2 to 11yrs. with hereditary angioedema (HAE)
Pts aged 6–11 years received 100mg (QM, n=16), while those aged 2–5yrs. received 100mg (Q2M, n=6). Andembry showed a favorable safety profile & treatment response, with most pts remaining attack-free over 12mos.
Full results will be…
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Arrowhead has reported topline P-III (SHASTA-3 & 4) trial results assessing plozasiran (25mg, SC, Q3M) vs PBO in sHTG pts (n=~750), where both trials met their 1EP of reduced median TGs by 79% & 81%, respectively, at 12mos. vs ~27%
Pooled analyses showed significant reductions in AP event rates & total incidence rate, with…
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Ipsen has reported topline P-III (E-BEOND & C-BEOND) trial results assessing Dysport (abobotulinumtoxinA) vs PBO in a total of 1,510 adults with episodic & chronic migraine, respectively
Both trials met their 1EP, with a reduction in monthly migraine days vs PBO & demonstrated a favorable safety profile; detailed results will be presented at a future…

