Shots:
The P-III (OCEANIC-STROKE) trial assessed asundexian (50mg, QD, PO) vs PBO, both in combination with antiplatelet therapy, in pts (n=12,327) for prevention of ischemic stroke after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack
Trial showed a 26% reduction in recurrent ischemic stroke without increased ISTH major bleeding across all subgroups, met key…
Shots:
Daiichi Sankyo has dosed the first patient with DS3790 in the P-I/II trial for pts with r/r B-cell non-Hodgkin lymphoma
The trial will assess DS3790 in ~420 pts with r/r B-cell NHL, evaluating safety endpoints as well as efficacy endpoints incl. overall response, DCR, DoR, time to response, PFS, & OS
DS3790 is a…
Shots:
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…
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Sanofi has reported P-III (LEAP2MONO) trial data assessing venglustat (QD, PO) vs enzyme replacement therapy (IV, Q2W) in 43 pts (≥12yrs.) with GD3
Trial met its 1EP, improving neurological symptoms measured by modified SARA total score & RBANS at Wk. 52, & achieved 3 of 4 key 2EPs, incl. reductions in spleen & liver…
Shots:
nChroma Bio has dosed the first patient with CRMA-1001, an epigenetic silencer, in a P-I/II trial for the treatment of hepatitis B virus (HBV) infection
The open-label study is evaluating the safety, tolerability, PK/PD, & efficacy of CRMA-1001 in adults with CHB across single & multiple-ascending dose cohorts, with enrollment ongoing
Additionally, the company…
Shots:
Roche reported positive topline results from the P-II (CT388-103) study evaluating CT-388, an investigational dual GLP-1/GIP receptor agonist, for the treatment of obesity
Once-weekly CT-388 (SC) achieved a statistically significant PBO-adjusted weight loss of 22.5% (p<0.001; efficacy estimand) at 48 wks. at the highest dose (24 mg), with no weight-loss plateau observed; 54% of…
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Neurocrine Biosciences has initiated a P-II study of investigational NBI-1065890 in adults with TD
P-II study of NBI-1065890 will enroll ~100 adults with TD, evaluating efficacy, safety, and tolerability, with the 1EP being change from baseline in Abnormal Involuntary Movement Scale (AIMS) total score at Wk 8
NBI-1065890 is a selective oral VMAT2 inhibitor…
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Ascletis Pharma reported that the first participants have been dosed in a US 13-week P-II study of ASC30, an oral small-molecule GLP-1 receptor agonist, for the treatment of type 2 diabetes mellitus, with topline data expected in Q3’26
The study will enroll ~100 pts and evaluate ASC30’s effects on HbA1c as a 1EP, and…
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Crinetics has dosed the first patient with atumelnant in the P-II/III (BALANCE-CAH) trial for the treatment of classic congenital adrenal hyperplasia (CAH) in children & adolescents
The study will evaluate atumelnant across 3 phases: a P-II semi-sequential dose-ranging Part A, followed by a P-III PBO-controlled Part B, & an OLE portion in Part C…
Shots:
Mabwell has dosed the first patient with 7MW4911 in a P- I/II study in the US for the treatment of advanced colorectal cancer & other advanced GI tumors
Preclinical studies showed that 7MW4911 delivered potent antitumor activity across CDX/PDX GI tumor models & outperformed MMAE/DXd-based ADCs in multidrug-resistant settings. It also reversed tumor progression after…

