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Changing primary endpoints in clinical trials: proceed with caution
Experts suggest taking caution when changing primary endpoints in active cancer clinical trials.
Marinus’ clinical trial of ganaxolone fails to meet primary endpoint
In response to the findings, Marinus is halting further clinical development of ganaxolone.
Rigel’s fostamatinib meets primary endpoint in Covid-19 clinical trial
Rigel Pharmaceuticals has reported that the Phase II clinical trial of its oral spleen tyrosine kinase (SYK) inhibitor fostamatinib in treating hospitalised Covid-19 patients met the primary endpoint of safety.
Aldeyra's Phase III clinical trial of Reproxalap meets primary endpoint
The investigational new drug candidate Reproxalap is intended for the treatment of dry eye disease and allergic conjunctivitis.
Viralytics' Phase II clinical trial of melanoma drug meets primary endpoint
Viralytics' (VLA) Phase II clinical trial of Cavatak or the CALM study has met its primary endpoint of progression-free survival (PFS) in patients suffering from late stage melanoma.
Cerecor’s Phase II clinical trial of CERC-301 to treat MDD fails to meet primary endpoint
US-based clinical-stage biopharmaceutical company Cerecor has reported that its Phase II clinical trial of CERC-301 to treat major depressive disorder (MDD) has failed to meet its primary endpoint.
Palatin Phase IIb female sexual dysfunction bremelanotide trial meets endpoints
Biopharmaceutical company Palatin Technologies has announced that its Phase IIb bremelanotide female sexual dysfunction (FSD) trial met the primary endpoint and key secondary endpoints.
Palatin to push through with dry eye therapy despite Phase III miss
Palatin’s dry eye therapy PL9643 failed to meet endpoints in the Phase III trial without statistical adjustments.
Ironwood and Allergan’s LINZESS trial meets primary endpoint
Ironwood Pharmaceuticals and Allergan have announced that a Phase IIIb clinical trial has met its primary multi-component endpoint in evaluating the safety and efficacy of LINZESS (linaclotide) on multiple abdominal symptoms in adult patients with IBS-C.
Neovacs reports data from Phase IIb trial of IFNα Kinoid
Neovacs has reported results from a Phase IIb clinical trial of IFNα Kinoid for the treatment of patients with moderate-to-severe lupus (SLE).
Pfizer and Astellas modify research protocols for ARCHES and EMBARK
Pfizer and Astellas Pharma have amended the protocols of two registrational Phase lll trials, ARCHES and EMBARK, which aim to examine the safety and efficacy of XTANDI (enzalutamide) in men with hormone-sensitive prostate cancer (HSPC).
Genkyotex reports positive interim results from GKT831 trial
Genkyotex has reported positive interim efficacy results from the Phase II trial of GKT831 for the treatment of primary biliary cholangitis (PBC).
Roche announces mixed Phase III results of etrolizumab
Roche has reported mixed top-line data from the Phase III clinical study programme of etrolizumab in patients with moderately to severely active ulcerative colitis.
Can anifrolumab become a breakthrough therapy for lupus patients?
Although anifrolumab met its primary endpoint in the TULIP-2 trial, it failed to meet a different primary endpoint in the Phase III TULIP-1 trial.
Merck says vericiguat’s VICTORIA trial met primary endpoint
Merck has reported that the Phase III VICTORIA clinical trial of vericiguat met its primary efficacy endpoint in patients suffering from worsening chronic heart failure with reduced ejection fraction (HFrEF).
Roche’s Tecentriq combination passes Phase III melanoma study
Roche has said that the Phase III IMspire150 clinical trial of Tecentriq (atezolizumab) plus Cotellic (cobimetinib) and Zelboraf (vemurafenib) met its primary endpoint in treatment-naive patients with BRAF V600 mutation-positive advanced melanoma.
Merck and Pfizer’s Steglatro meets primary goal in VERTIS CV trial
Merck (MSD) and Pfizer have reported that the Phase III VERTIS cardiovascular (CV) outcomes clinical trial of Steglatro (ertugliflozin) met its primary endpoint in patients with type 2 diabetes and atherosclerotic CV disease.
Cytokinetics’ FORTITUDE-ALS trial fails to meet primary endpoint
Biopharmaceutical firm Cytokinetics has reported findings obtained from the Phase II FORTITUDE-ALS clinical trial of reldesemtiv in patients with amyotrophic lateral sclerosis (ALS), a neurodegenerative disease.
Psoriasis development criteria more competitive than ever
Standards for psoriasis market clinical trials are more rigorous due to the competitive nature of the sector and the need for new developments.
Sanofi to end tusamitamab ravtansine development after trial failure
Tusamitamab ravtansine did not meet the primary endpoint of progression-free survival versus docetaxel in the CARMEN-LC03 trial.