Shots:
Greywolf Therapeutics has dosed its first patient with GRWD0715 in P-I/II (EAST-1) trial (n=~141) for the treatment of axial spondyloarthritis (axSpA)
The P-I study will assess safety & tolerability of GRWD0715 in ~24 healthy participants & ~36 axSpA pts to utilize the results with proof-of-mechanism data for selecting the active dose for P-II trial…
Shots:
The P-III (KEYNOTE-905/EV-303) trial randomized cisplatin-ineligible MIBC pts to Arm A (3 cycles of Keytruda + surgery with 14 subsequent cycles), Arm B (surgery alone), or Arm C (3 cycles of Keytruda + Padcev before surgery, followed 6 cycles of the combination, then 8 cycles of Keytruda alone)
Arms C & B showed improved…
Shots:
Novartis has reported topline P-III (VAYHIT2) trial data assessing ianalumab (3 or 9mg/kg, QM, IV) + eltrombopag vs PBO + eltrombopag in pts with primary immune thrombocytopenia (ITP) who failed 1L corticosteroid treatment
Trial met its 1EP with prolonged time to treatment failure & showed increased sustained platelet count improvement at 6mos. (2EP); data…
Shots:
Stoke Therapeutics & Biogen have dosed their first patient with zorevunersen in global P-III (EMPEROR) trial for the treatment of Dravet syndrome; Trial has initiated in the US, UK, & Japan, with an EU study planned
Trial will assess zorevunersen (70mg on Day 1 & Wk. 8, then 45mg at Wks. 24 & 40) vs sham…
Shots:
Novartis has reported topline P-III (NEPTUNUS-1 & 2) trial data assessing ianalumab (VAY736) in adults with active Sjögren's disease
NEPTUNUS-1 assessed ianalumab (300mg, QM) vs PBO in 275 Sjögren's disease pts for 52wks. while NEPTUNUS-2 evaluated ianalumab (300mg; QM or Q3M) vs PBO for up to 52wks. in 504 pts; pts could then either…
This week, PharmaShots’ news was all about the updates on clinical trials, Regulatory, Pharma, MedTech, Biotech, M&A and Biosimilars. Check out our full report below:
Roche Reports P-III (Portal) Trial Data on Susvimo for Neovascular Age-Related Macular Degeneration (nAMD)
Read More: Roche
Ethris Reports First Patient Dosing in P-IIa Trial of ETH47 for Asthma
Read…
Shots:
Genmab has reported P-III (EPCORE FL-1) trial data assessing epcoritamab (SC) + rituximab & lenalidomide (R2) vs R2 alone for the treatment of adult patients with r/r follicular lymphoma
The trial met dual primary endpoints with improved ORR and PFS, reducing risk of progression or death by 79%; interim data will be submitted to…
Shots:
Flare Therapeutics has dosed its first patient with FX-909 in P-Ib trial for the treatment of locally-advanced or metastatic urothelial cancer
The P-Ib trial will assess FX-909 (30 & 50mg; QD) in 40 pts, incl. a biomarker-defined population, building on clinical PoC achieved in P-Ia, with P-Ia data to be presented in 2025. Efficacy…
Shots:
Fapon Biopharma has enrolled the first patient in China for its P-I trial of FP008 for advanced solid tumors, conducted at Zhejiang Cancer Hospital. The patient completed the DLT observation with a favorable safety profile. The trial focuses on evaluating FP008's safety and tolerability
FP008 demonstrated favorable safety and PK in monkey studies and…
Shots:
Marea Therapeutics has dosed its first patient with MAR001 in P-IIb (TYDAL-TIMI 78) trial for adults at increased risk of atherosclerotic cardiovascular disease (ASCVD)
Trial will evaluate MAR001 (300, 450, 900mg; Q4W) vs PBO in ~216 adults with elevated triglycerides & remnant cholesterol at high ASCVD risk, with the 1EP assessing % change from…

