In February 2020 , Izana Bioscience completed the phase II NAMASTE trial which evaluated the efficacy of namilumab, in patients with moderate-to-severely active axial spondyloarthritis, including those previously exposed to anti-TNF therapy (IZN101; EudraCT2018-000176-15; NCT03622658). Evaluation of the proportion of subjects who achieve an ASAS20 clinical response, at week 12, was the defined primary endpoint of the trial. The randomised, double blind trial, which was initiated in June 2018, enrolled 42 patients in the UK  .
In April 2020, Izana Bioscience announced that it is providing support for a clinical development programme for namilumab, for the treatment of patients with rapidly worsening COVID-2019 infections in Italy, under the compassionate use pathway. The comapany also reported that the therapy granted emergency access. The company is in discussions with other global regulatory authorities, including the UK, for further development of namilumab for the treatment of COVID-2019 infections   .
In May 2017, Takeda reported that it had stopped clinical development of namilumab for the treatment of patients with rheumatoid arthritis. The decision was based on strategic alignment reasons, and the product will be pivoted to external value creation (Takeda pipeline, May 2018). Phase II development was underway for rheumatoid arthritis in Japan (Takeda pipeline, February 2016).
In November 2016, Takeda terminated the phase II TELLUS trial as per the strategic decision to understand data from psoriasis study NCT02129777 [see below] and to wait for results of formal proof of concept study NCT02379091 [see below] (15SC0020; MT203-2004; REec-2015-1508; U1111-1165-2221; NCT02393378; EudraCT2014-002945-23). The trial was initiated in April 2015 to evaluate the efficacy of subcutaneous namilumab compared with adalimumab (both in combination with methotrexate), in patients with moderate to severe early rheumatoid arthritis who have showed an inadequate response to prior methotrexate therapy. The open-label trial enrolled seven patients in Czech Republic, Estonia, Spain, Russia and the UK  .
In November 2016, Takeda completed the phase II NEXUS trial which evaluated the safety and efficacy of three dose levels of subcutaneous namilumab (20, 80 and 150 mg), in combination with methotrexate, in patients with moderate to severe rheumatoid arthritis who showed inadequate response following treatment with methotrexate and a TNF-inhibitor (JapicCTI-152979; NCT02379091; EudraCT2013-002805-76). The primary endpoint was the change from baseline in disease activity, assessed at week 12. The randomised, parallel-assignment trial initiated in November 2014, enrolled 108 patients in the UK, Bulgaria, Japan, Czech, South Korea, Poland, Russia and Spain  .
A randomised, double-blind, placebo-controlled phase Ib trial was completed in Bulgaria and the Netherlands in patients with mild to moderate rheumatoid arthritis who were receiving methotrexate (PRIORA; NCT01317797). The trial evaluated the safety and tolerability of subcutaneous injections of namilumab, compared with placebo, in 24 patients. Pharmacokinetics, biomarkers and preliminary efficacy were also assessed  .
Takeda initiated a phase I trial in November 2014, to investigate the safety, pharmacokinetics and pharmacodynamics of a single subcutaneous injection of namilumab in healthy volunteers (NCT02354599). Approximately 32 volunteers in Japan will be randomised to receive namilumab (80mg, 150mg or 300mg) or placebo  .
Nycomed initiated a randomised, double-blind, placebo-controlled phase I trial in June 2009 to evaluate the safety and pharmacokinetics of namilumab   . In April 2009, Nycomed filed the first Clinical Trial Application for namilumab, in Europe. Micromet received $US2 million from Nycomed for this milestone  .
Micromet initiated preclinical safety studies of namilumab in June 2008. As a result, Micromet received a milestone payment of $US 775 000 from Nycomed  .
As of May 2017, Takeda discontinued development of namilumab for plaque psoriasis in Latvia, Poland, Germany, Denmark, and Canada, because a phase II trial did not meet its primary endpoint (Takeda FY2016 Q4 results, May 2017).
Takeda terminated a randomised, double-blind, placebo-controlled phase II trial, that was designed to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of four dose levels of namilumab in patients with moderate to severe plaque psoriasis; the study was initiated in May 2014 (Neptune; NCT02129777; EudraCT2013-002806-30; U1111-1146-1219; 172235; M1-1188-203). Patients were to be dosed on days 1, 15, 43 and 71, and the primary endpoint was the percentage of patients achieving an improvement in PASI 75 at week 12. The trial was expected to enrol approximately 122 patients in Germany, Denmark, Poland, Latvia and Canada  .
Izana Bioscience, in December 2017, announced the award of a grant of £1.35 million by Innovate UK, to support a phase II proof-of-concept study in ankylosing spondylitis  .