Nordic Life Science 1
CLINICAL TRIALS Research on growth disorders, Nov
o Nordisk PHASE II BERGENBIO STARTS NEW TRIAL Lundbeck initiates new Phase II study The company has initiated a phase II-study (proof of concept-study) with the compound Lu AF11167 to confirm its potential as a treatment for patients with schizophrenia who are experiencing persistent negative symptoms. LU AF11167 REPRESENTS a new approach to treating negative symptoms of schizophrenia, working by inhibiting the activity of the PDE10-enzyme in the brain. This affects the signaling of the neurotransmitter dopamine in a manner that may specifically improve negative symptoms while positive symptoms remain controlled. Lu AF11167 has been invented by Lundbeck. “We are pleased to advance the clinical development of Lu AF11167, which has the potential to improve the treatment of patients with schizophrenia who are experiencing persistent negative symptoms. We look forward to learning more about this potential in the proof of concept-study,” says Mads Dalsgaard, Senior Vice President, Clinical Development at Lundbeck. The primary objective of the phase II study is to evaluate the efficacy on negative symptoms of two doses of Lu AF11167 versus placebo as a monotherapy in patients with schizophrenia who have persistent prominent negative symptoms. The secondary objective will be to evaluate the efficacy of Lu AF11167 on patients’ functioning, as well as the safety and tolerability of the compound. This 3-arm study will randomize a total of 240 patients (80 patients per arm) from various European countries. The first patient has been dosed in an investigator-initiated phase II trial of bemcentinib in patients with highrisk myelodysplastic syndrome (MDS) who have failed first-line treatment with hypomethylating agents. T PHASE I/ I I NORDIC NANOVECTOR PRESENTS NEW RESULTS THE COMPANY HAS PRESENTED NEW DATA FROM ITS LYMRIT 37-01 STUDY OF BETALUTIN. U PDATED RESULTS FROM THE LYMRIT 37-01 Phase 1/2 clinical study of Betalutin in patients with relapsed/refractory indolent nonHodgkin’s lymphoma (R/R iNHL) have been presented at the American Society of Hematology (ASH) Annual Meeting & Exposition in December. The published dataset (as of 2 November 2018) includes 74 evaluable patients. All patients received Betalutin as a single administration and have six or more months of follow-up. “We are very pleased with the clinical data, which continue to support our decision to compare two promising dose regimens in the pivotal Phase 2b PARADIGME trial. The efficacy and safety profile of Betalutin, the duration of response and the convenience of a single administration underscore the potential of Betalutin for the treatment of patients with advanced-stage follicular lymphoma,” says Lisa Rojkjaer, MD, Chief Medical Officer of Nordic Nanovector. The conclusions from the updated study results are that a single administration of Betalutin is well-tolerated and continues to demonstrate encouraging antitumor activity in recurrent iNHL, especially in follicular lymphoma (FL) patients, the primary NHL population for which Betalutin is being developed. HE TRIAL (BGBIL009 / BERGAMO) aims to confirm the efficacy of bemcentinib monotherapy in patients with high-risk MDS and AML and will enroll up to 43 patients at 8 hospitals in Germany, France, the Netherlands and Italy. The study will allow for the evaluation of potential predictive and pharmacodynamic biomarkers for MDS in bone marrow and blood, including those associated with patient benefit from bemcentinib. THE TRIAL MAY also enroll a proportion of patients with acute myeloid leukaemia (AML) reports the company. The study is being sponsored by GWT-TUD GmbH (a specialist cancer clinical research institution associated with the University of Dresden, Germany) with the support of BerGenBio.