Announcement NeuroSearch updates on pipeline progress and status NeuroSearch has a comprehensive and broad development pipeline, counting 19 development programmes with 16 novel drug candidates. All our drug candidates originate from our in-house drug discovery and represent potentially new and improved treatment options for a large number of disease indications where significant unmet medical needs exist - mainly in the field of central nervous system (CNS) disorders. Drug candidate Indication Phase Partner ACR16 Huntington's disease Phase II/III Own programme NS2359 Depression Phase II GSK Tesofensine Obesity/type 2 diabetes Phase II Own programme NS2359 ADHD Phase II GSK NS1209 Epilepsy, pain Phase II Own programme ABT-894 ADHD Phase II Abbott ACR16 Schizophrenia Phase I Astellas ABT-894 Neuropathic pain Phase I Abbott ACR325 Bipolar disorder Phase I Own programme ABT-107 Schizophrenia a.o. Phase I Abbott ABT-560 Dementia Preclinical Abbott NSD-503 COPD Preclinical Own programme ACR343 Parkinson's disease Preclinical Own programme NSD-551 Brain cancer Preclinical TopoTarget NSD-644 Pain, psychiatric diseases Preclinical GSK option NSD-708 Anxiety Preclinical GSK option NSD-788 Anxiety a.o. Preclinical GSK option NSD-683 CNS diseases Preclinical Abbott NSD-726 Autoimmune diseases Preclinical GSK option Especially over the past 12-18 months, we have succeeded in growing and building value to the pipeline, and our drug development programmes continue to progress in accordance with plans. Below is an update on relevant programmes: ACR16 (Huntington's disease) - Ready for Phase III application With the lead drug candidate ACR16 which is a dopaminergic stabiliser ready for Phase III application within Huntington's disease, we have concluded six months' toxicology studies. The results from these studies are satisfactory, confirming earlier tolerability and safety data, and thus allowing us to conduct clinical Phase III studies. At the beginning of June, we have held a pre-IND meeting with the FDA (the US regulatory authorities). The outcome encourages us to submit an IND and to pursue clinical development of ACR16 for Huntington's disease in the US. Also, we have supportive discussions ongoing with EMEA (the European regulatory authorities) in preparation for Phase III initiation in Europe. We expect to file for the necessary regulatory approvals during the summer period with a view to initiating a clinical Phase III programme with ACR16 in Huntington's disease in the second half of 2007. Further, we maintain our expectations to apply for market registration of ACR16 in 2009. Tesofensine for Obesity/type 2 diabetes - Clinical Phase II extension study NeuroSearch has received regulatory approval and initiated patient dosing in TIPO-4, an open-label, clinical study with the drug candidate, tesofensine as an extension to the ongoing clinical Phase II Proof-of-Concept study in obesity (TIPO-1). In TIPO-4, all patients having concluded six months' treatment in TIPO-1 with either tesofensine or placebo will be offered another six months of treatment. The dosing of tesofensine will be 0.5 mg daily for all patients with the possibility to increase to 1 mg daily according to tolerance and efficacy. The aim of TIPO-4 is to evaluate tesofensine's continued safety and tolerability as well as to generate additional observations on maintenance of effect (weight reduction) for a total of up to 12 months. The patients in TIPO-4 will follow the same diet and exercise programme as in TIPO-1. Results from both our TIPO-1 clinical Phase II Proof-of-Concept study and from our TIPO-2 metabolic evaluation study are still expected in the second half of 2007. 12 month's data on tesofensine based on the TIPO-4 extension study is expected in the first half of 2008. NS1209 for Status epilepticus and pain - Clinical results and future plans NeuroSearch has concluded and evaluated data from two small clinical studies with NS1209; a Phase IIa study in status epilepticus and a Phase I/II in neuropathic pain. As announced in our interim report for the first quarter of 2007, in the pain study, NS1209 showed to be significantly superior to placebo in alleviating some key symptoms of neuropathic pain. Also, patients' rating of overall pain was significantly improved, while the more stringent primary endpoint did not reach statistical significance. NS1209 demonstrated a good safety profile and was well tolerated by all treated patients. Given the small size of the study, these results are encouraging. For the epilepsy study, results were inconclusive due to a small evaluable study population and too high variations in the individual patients' base lines. We have now made a thorough evaluation of the combined clinical data material on NS1209 together with developmental requirements going forward. Based upon this and necessary prioritisation of financial resources and capacity in our development organization, NeuroSearch has now decided to seek a specialised partner for the continued development of NS1209. NSD-726 - New development candidate for the treatment of autoimmune diseases NSD-726 has been chosen as the first development candidate from our ion channel research programme with autoimmune diseases. The compound has shown promising effect in preclinical models, and preclinical development will commence as soon as possible. Our alliance partner GlaxoSmithKline has option on NSD-726 under our extended alliance from November 2006. The selection of NSD-726 brings a total of seven new drug candidates being transferred from our drug discovery platform and into the development pipeline since the beginning of 2006, which we consider highly satisfactory. Asger Aamund Chairman of the Board Contact persons: Flemming Pedersen, CEO, +45 2148 0118 Hanne Leth Hillman, Vice President, Director of IR & Corporate Communications, +45 4017 5103 NeuroSearch is a Scandinavian biopharmaceutical company listed on the OMX Copenhagen Stock Exchange (NEUR). Our core business covers the development of novel drugs, based on a broad and well-established drug discovery platform focusing on ion channels and CNS disorders. A substantial part of the company's activities are partner financed through a broad alliance with GlaxoSmithKline (GSK) and collaborations with among others Abbott and Astellas. The drug pipeline comprises ten clinical development programmes: ACR16 in Huntington's disease (Phase III preparation), tesofensine in obesity/type 2 diabetes (Phase II), NS2359 in depression (Phase II) and ADHD (Phase II) in partnership with GSK, NS1209 in epilepsy and pain (Phase II), ABT-894 in ADHD (Phase II) and pain (Phase I) in partnership with Abbott, ACR16 in schizophrenia (Phase I) in partnership with Astellas, ACR325 in bipolar disorder (Phase I) and ABT-107 for the treatment of various CNS diseases (Phase I) in collaboration with Abbott. In addition, NeuroSearch has a broad portfolio of preclinical drug candidates and holds equity interests in several biotech companies.
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