The company provides an update on its clinical development programme, including updated guidance on expected milestones for the pivotal PARADIGME trial, and its financial outlook.
A re-assessment of expected recruitment rates has led the company to revise its timelines for the pivotal PARADIGME Phase 2b trial with Betalutin in third line (3L) follicular lymphoma (FL) patients. Results from PARADIGME are targeted for 1H 2020 (previously 2H 2019) and first regulatory filing in 2020. The first patient is expected to be dosed in 1H 2018.
The company will focus its resources towards PARADIGME and other Betalutin clinical programmes, which has led to the decision to postpone the start of the first-in-human clinical trial with Humalutin for the foreseeable future; this study was being prepared to start in 2H 2018.
Guidance is unchanged for previously reported milestones for ARCHER-1 (Betalutin plus rituximab in second line FL; first patient dosed) and LYMRIT 37-05 (Betalutin in R/R diffuse large B cell lymphoma, DLBCL; preliminary data read-out), both anticipated in 2H 2018.
According to the company press release, financial resources are expected to be sufficient to reach data read-out from PARADIGME.
“While we are encouraged with the progress being made to the start-up of the pivotal PARADIGME study, a re-analysis of the patient enrolment rate and the fact that it has taken longer than expected to enrol the first patient have led us to adjust the timelines we previously communicated. We now expect to deliver data from PARADIGME in the first half of 2020. The PARADIGME study reflects our conviction in the significant potential of Betalutin based on the promising clinical data generated to-date. We therefore remain committed to completing this robust study, which is designed to select the best dosing regimen to support Betalutin as an important new treatment option for 3L FL patients,” said Lisa Rojkjaer CMO of Nordic Nanovector.