Shots: The company initiates P-III clinical trial to evaluate the efficacy, safety, tolerability, PK, and immunogenicity of SB17 vs Stelara in a ratio (1:1) in patients with moderate to severe plaque psoriasis Additionally, patients either continue on Stelara or transition to SB17 @28wks. The IPs (SB17 or Stelara, q12w) will be administered @0, 4 and […]Read More
Shots: The P-III ASCEND program includes 5 studies i.e ASCEND-ND, D, ID, NHQ & TD studies evaluating efficacy & safety of daprodustat vs ESA in ~8,000 patients with anemia due to CKD for ~ 3.75yrs. The program met its 1EPs in 5 studies i.e improvement in Hgb levels in untreated patients and maintaining Hgb levels […]Read More
Shots: The first patient has been dosed in a P-III clinical study evaluating the efficacy and safety of BAT2206 vs reference Stelara in ~ 472 patients with moderately to severely PsO BAT2206 represents the 4th biosimilar of Bio-Thera’s portfolio to enter P-III study. The advancement of BAT2206 in P-III study demonstrates company’s commitment to develop […]Read More
Shots: The P-III SELECTION trial comprises 2 induction trials & a maintenance trial evaluating filgotinib (200/100 mg) vs PBO in adult patients with active UC Induction studies results: improvements in PROs of SF & RB in biologic-naïve & biologic-experienced patients (200mg dose). In induction study A & B (18.8% vs 9.5% & 10.7% vs 4.2%) […]Read More
Shots: The P-III HELP OLE study evaluating the safety & efficacy of Takhzyro (300mg, q2w) in 212 patients aged ≥12yrs. with HAE attacks for ~2.5 yrs. Results: 87.4% mean reduction in attack rate compared to baseline & median reduction was 97.7%. Additionally, @70 day steady-state, attack rates were further reduced to a mean of 92.4% […]Read More
Shots: The companies collaborated to evaluate OncoSec’s TAVO + Merck’s Keytruda vs SoC in a P-III KEYNOTE-C87 trial in ~400 patients with metastatic melanoma who are refractory to immune checkpoint therapy across the US, Canada, EU & Australia The companies will responsible for internal costs with OncoSec covering the third-party costs. The trial is intended […]Read More
Shots: The P-III Xplore study involves assessing ranibizumab biosimilar vs Lucentis in 583 patients. The study met its 1EPs demonstrating the equivalent efficacy in BCVA @ 8wks. treatment Additionally, the interim analysis of 6mos. data demonstrated that the biosimilar has a similar PK, safety, and immunogenicity profile compared to Lucentis. The companies plan to submit […]Read More
Shots: The ongoing P-III maintenance study evaluates the efficacy and safety of upadacitinib (15/30 mg, qd) vs PBO in patients with a mod. to sev. UC The study met the 1EPs & 2 EPs i.e @ 52 wks., patients achieved clinical remission (per Adapted Mayo Score) (42%/ 52% vs 12%), endoscopic improvement (49%/62% vs 14%), […]Read More
Shots: The P- III HOPE-B gene therapy trial involves assessing etranacogene dezaparvovec in 54 patients with severe and moderately hemophilia B The results showed that the patients achieved sustained increases in FIX activity @ 1 yr. post-infusion with a mean FIX activity of 41.5% compared to 39.0% @ 26-wks of follow-up, reduced the ABR by […]Read More
Shots: The P-III COMET-ICE trial involves assessing sotrovimab vs PBO in 1057 patients with mild-to-moderate COVID-19 The trial meets its 1EPs i.e. a 79% reduction in hospitalization for >24hrs. or death due to any cause @29day. Additionally, NIH update its treatment guidelines to recommend the use of therapy for non-hospitalized patients with COVID-19 who are […]Read More
Copyright ©2021 PharmaShots | Powered by Octavus Consulting
