The clinical trial results 6 November 2026 span immune thrombocytopenia, anaemia in chronic kidney disease, red cell transfusion and pterygium.
InnoCare’s orelabrutinib met its primary endpoint in chronic primary immune thrombocytopenia. Akebia’s three-times-weekly vadadustat met its non-inferiority endpoint against an erythropoiesis-stimulating agent in anaemia due to chronic kidney disease. Cerus’s INTERCEPT red blood cells met their non-inferiority efficacy endpoint in the Phase 3 RedeS trial. Cloudbreak’s CBT-001 met its primary endpoints in pterygium. Here, Life Science Daily News brings you the week’s most significant readouts.
Orelabrutinib Meets Its Primary Endpoint in a Phase 3 Immune Thrombocytopenia Study
InnoCare announced Phase 3 results for orelabrutinib in immune thrombocytopenia on 5 November. The study met its primary endpoint of durable response, which was 32.8 per cent with orelabrutinib. The company reports this as an improvement of 25.5 per cent over placebo (p=0.0001). In patients who responded, median time to initial platelet response was 14 days with orelabrutinib against 42 days with placebo. The company also reports superiority over placebo as early as day 7. It reports a significant reduction in the need for rescue therapy, without giving figures. The safety profile was described as comparable to placebo, with most treatment-emergent adverse events at grade 1 or 2.
The placebo-controlled, double-blind, multicentre study enrolled 196 previously treated Chinese adults with chronic primary immune thrombocytopenia. Patients were randomised 2:1 to once-daily oral orelabrutinib 50 mg (131 patients) or placebo (65 patients) over 24 weeks. The primary endpoint required a platelet count of at least 50×109/L at four of six scheduled visits. The visits fell in the final 12 weeks, and responses had to occur without rescue therapy. Orelabrutinib is a BTK inhibitor. A new drug application for the indication has been accepted in China. InnoCare describes this as orelabrutinib’s first NDA acceptance in autoimmune disease. Prof. Yu Hou will give an oral presentation at the American Society of Hematology annual meeting on 14 December 2026. The press release did not state an NCT number, and the data are from a Chinese population only.
Vadadustat Dosed Three Times Weekly Meets Non-Inferiority to an ESA in the VOCAL Trial
Akebia Therapeutics reported topline VOCAL data for vadadustat (Vafseo) on 5 November. The three-times-weekly regimen met the primary non-inferiority endpoint for mean change in haemoglobin from baseline to weeks 20 to 24. The difference against the erythropoiesis-stimulating agent Mircera was -0.45 g/dL (95 per cent CI -0.71 to -0.19). The lower bound sat above the prespecified non-inferiority margin of -0.75 g/dL. Exposure-adjusted serious treatment-emergent adverse events were 159.7 per 100 patient-years with vadadustat and 183.9 with the ESA. The company describes these rates as similar and gives no confidence interval or statistical test.
VOCAL (NCT06901505) is an open-label study in 353 patients with anaemia due to chronic kidney disease on in-centre haemodialysis. Patients were randomised 1:1 across 18 clinics of a large dialysis organisation. Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor. The approved regimen is once daily, so the three-times-weekly schedule remains investigational, and the release gives no filing plans. The result is topline and subject to final verification. Vafseo carries a boxed warning for risk of death, myocardial infarction, stroke, venous thromboembolism and vascular access thrombosis. It is not indicated for anaemia due to chronic kidney disease in patients not on dialysis. The company points to the 2,116-patient VOICE trial against Epogen as supporting data.
INTERCEPT Red Blood Cells Meet Non-Inferiority in the Phase 3 RedeS Trial
Cerus Corporation announced positive topline results from the Phase 3 RedeS trial on 2 November. In the modified intent-to-treat efficacy analysis, the adjusted haemoglobin increment was 1.996 g/dL for INTERCEPT red blood cells (195 patients). It was 2.050 g/dL for conventional red blood cells (199 patients). The estimated difference was -0.054 g/dL (95 per cent CI -0.210 to 0.103). The prespecified non-inferiority margin was -0.32 g/dL (p=0.004). Related treatment-emergent adverse events occurred in 3.4 per cent of the INTERCEPT arm (9 of 267). The control arm rate was 2.5 per cent (7 of 276; p=0.634).
The company also reported INTERCEPT red blood cell-specific antibodies in 2.2 per cent of the INTERCEPT arm (6 of 267). No control arm patients developed them (p<0.013). It describes these as low-titre and transient, with no evidence of haemolysis or clinical impact. Cerus says studies to evaluate them further are ongoing. RedeS (NCT03037164) compares pathogen-reduced red cells with conventional red cells in patients requiring transfusion support. The release does not state the blinding design. Secondary endpoints have not been reported. The FDA has not reviewed the final clinical study report and its assessment may differ from Cerus’s. INTERCEPT red cells remain investigational in the United States and are under regulatory review in Europe.
CBT-001 Meets Its Primary Endpoints in a Phase 3 Pterygium Study
Cloudbreak Pharma announced topline Phase 3 results for CBT-001 on 4 November. Both the 0.1 per cent and 0.2 per cent doses outperformed vehicle on conjunctival hyperaemia at Month 3 (p<0.001). Both also outperformed vehicle on preventing lesion-length progression at Month 12 (p<0.001). The company reports a benefit over vehicle of about 10 per cent of baseline lesion size. It says the effect had not plateaued by Month 12. The release gives no confidence intervals or per-arm means. Superficial punctate keratitis was the most common adverse event at the lower dose. It affected 20 per cent of patients, against 8 per cent with vehicle. Most cases resolved with artificial tears.
The multi-regional, double-masked, vehicle-controlled study (NCT05456425) randomised 659 patients. They received twice-daily CBT-001 0.1 per cent (164), 0.2 per cent (329) or vehicle (166) for 24 months. A 12-month double-masked extension follows for additional safety data. CBT-001 is a multi-kinase inhibitor eye drop that the company says targets the angiogenic and fibrogenic drivers of pterygium. Cloudbreak intends to meet the FDA to discuss next steps. The results are unaudited topline data. The company’s shares have been suspended from trading in Hong Kong since 10 September 2026. The release itself flags this for investors.
Looking Ahead
This week’s clinical trial results 6 November 2026 are mostly clean on their stated endpoints, but each carries a limit. InnoCare’s orelabrutinib result is placebo-controlled and shows a sizeable difference in durable response. However, the population is Chinese, and the release omits an NCT number and several figures. Akebia’s VOCAL and Cerus’s RedeS are non-inferiority readouts. These show that a regimen or product is not meaningfully worse than a comparator, rather than better. VOCAL is open-label, and Cerus reported antibody findings that sit outside the efficacy comparison.
Cloudbreak’s data are the least complete: per-arm results are not given and the release is unaudited. The safety signal at the lower dose is also notable. Regulatory outcomes for all four remain open. Life Science Daily News will continue to cover the readouts that matter across the global life sciences pipeline.
Read the 30 October 2026 clinical trials roundup.
