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New Drugs Online Report for davunetide
Information
Generic Name:
davunetide 
Trade Name:  
Entry Type: Licence extension  
 
Developmental Status
UK: Discontinued 
EU: Discontinued 
US: Discontinued 
UK launch Plans: Available only to registered users
Actual UK launch date:  
Comments
This product was withdrawn from the Community register of designated orphan medicinal products in April 2013 on request of the sponsor [9].  
02/07/2013 14:05:24
Dec 12: Clinical trial programme halted [8]. 
20/12/2012 08:51:29
Granted orphan drug status in the US in Jan 10 [5]. 
27/04/2012 17:01:30
Granted orphan drug status in the EU for treatment of progressive supranuclear palsy in Mar 10 [4]. 
25/11/2011 17:06:41
Jan 11: PII/PIII study started 4Q 2010 [3]. 
10/01/2011 16:19:13
April 10: Fast track status in US (1) 
07/04/2010 08:48:26
 
Trial or other data
Dec 12: The pivotal PII/III trial of davunetide for progressive supranuclear palsy (PSP) failed to demonstrate efficacy. The study had co-primary outcome measures: the Progressive Supranuclear Palsy Rating Scale (PSPRS), and the Schwab and England Activities of Daily Living (SEADL). Data analysis failed to detect an effect on either measure. There was also no evidence of an effect on secondary or exploratory endpoints in the pre-specified analysis. The Company will not allocate any additional capital to research and development activities for davunetide at this time [8]. 
20/12/2012 08:50:53
Nov 12: Patient treatment has been completed in the multinational PII/III trial. Top-line data from the trial is expected in Dec 12 [7].  
15/11/2012 10:25:27
Pivotal PII/III trial (NCT01110720) is expected to complete in Dec 12 [6]. 
27/04/2012 17:03:46
Jan 11: Enrollment in a pivotal PII/III began in 4Q 2010. The study will be conducted under a Special Protocol Assessment (SPA), granted by the FDA, at sites in the US, UK, Australia, Canada, France and Germany. The double-blind study will enroll 300 patients randomized 1:1 to receive either placebo or 30mg of davunetide twice a day for 12 months. The primary outcomes will be the Progressive Supranuclear Palsy Rating Scale (PSPRS) and the Schwab and England Activities of Daily Living (SEADL) scale. Secondary measures will include Clinical Global Impression (CGI) and brain imaging by magnetic resonance tomography (MRI). Additional exploratory endpoints include cognitive and executive function as well as cerebrospinal fluid (CSF) biomarkers [3].  
10/01/2011 16:17:53
Aug 10: Clinical trial to be initiated H2 2010 to determine the efficacy of davunetide in patients with PSP. [2] 
17/08/2010 08:22:31
Mar 09: Top-line results from a schizophrenia imaging sub-study showing that 12 weeks of treatment with davunetide resulted in a statistically significant increase in levels of a biomarker that is an important indicator of brain cell health. (1) 
07/04/2010 08:51:58
Dec 09: Phase IIa clinical trial results show davunetide improved memory function of schizophrenia patients and had a positive impact on the ability of these patients to carry out important activities in their daily lives. Data presented at the annual meeting of the American College of Neuropsychopharmacology. (1) 
07/04/2010 08:51:41
 
Evidence Based Evaluations
NHSC  http://www.nhsc-healthhorizons.org.uk/files/downloads/1887/2256.7836e1fd.Davunetideintranasal_July2012.pdf 
   
References  
Available only to registered users
Category
BNF Category:
Drugs for dementia (04.11)
Pharmacology: Activity dependent neuroprotective protein (ADNP)  
Epidemiology: PSP is one of a group of progressive disorders called frontotemporal dementia (FTD), that affect the frontal and temporal lobes of the brain. Approximately 20,000 and 50,000 persons in the U.S. and EU respectively have PSP.  
Indication: Progressive supranuclear palsy 
 
Method(s) of Administration
Intranasal 
 
Company Information
Name: Allon Therapeutics Inc 
US Name: Allon Therapeutics Inc 
 
NICE Information
In timetable: No  
When:  /