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The HDL/HDAC heard from Joachim Tedoff, M.D., head of research for the Swedish pharmaceutical company Carlsson Research (founded by Nobel Prize winner Arvid Carlsson). Phase II results of their proprietary compound look good and they are planning Phase III trials although they haven't decided in which country. The compound, called ACR 16, received orphan drug status from the FDA earlier this year. Check out the HDL www.hdlighthouse.org for updates.
Carlsson Research Reports Positive Effects of ACR16 in Huntington Disease Phase II Study
http://www.carlssonresearch.se/news_fullpost.asp?news_id=6D30A4872B6F4109
Carlsson Research announces that the results from the ACR16C007 Phase II study indicate that ACR16 improves the symptoms associated with Huntington disease. The study was performed in six University clinics in Sweden and Norway.
The study ACR16C007 is a double blind, placebo-controlled study, investigating the effects of ACR16 and placebo in patients with Huntington disease. Altogether 58 patients were randomized to receive either ACR16 or placebo for four weeks. In the study, effects on commonly encountered symptoms such as disturbances in motor function, psychiatric symptoms as well as cognitive functions were assessed.
ACR16 was well tolerated; analysis showed there was no appreciable difference between the treatment groups, placebo or ACR16, in the quality, frequency, or severity or of side effects. ACR16 treatment improved motor function, particularly chorea (involuntary movements), gait and dysarthria. Subsequent analysis also demonstrated that ACR16 reduced akinesia, a symptom characterized by underlying slowness and poverty of movements. There was also a strong trend towards reduction of symptoms of anxiety and depression in ACR16 treated patients and a marked improvement in performing the Trail Making test, a test for cognitive function.
Dr Joakim Tedroff, Chief Medical Officer at Carlsson Research stated “the results from this study are very encouraging and validates our drug discovery technology, ISP, in humans. We are particularly encouraged by the finding of reduced akinesia, a symptom strongly associated with functional decline in Huntington disease patients. This study supports our development approach for ACR16 in the disorder”.
Given the broad action of ACR16 in preclinical models, Carlsson Research believes ACR16 can be used as a symptomatic treatment for a number of symptoms associated with Huntington disease including motor and mental symptoms. Phase III studies will now be undertaken to bring the compound to the market.
Carlsson Research announces that the results from the ACR16C007 Phase II study indicate that ACR16 improves the symptoms associated with Huntington disease. The study was performed in six University clinics in Sweden and Norway.
The study ACR16C007 is a double blind, placebo-controlled study, investigating the effects of ACR16 and placebo in patients with Huntington disease. Altogether 58 patients were randomized to receive either ACR16 or placebo for four weeks. In the study, effects on commonly encountered symptoms such as disturbances in motor function, psychiatric symptoms as well as cognitive functions were assessed.
ACR16 was well tolerated; analysis showed there was no appreciable difference between the treatment groups, placebo or ACR16, in the quality, frequency, or severity or of side effects. ACR16 treatment improved motor function, particularly chorea (involuntary movements), gait and dysarthria. Subsequent analysis also demonstrated that ACR16 reduced akinesia, a symptom characterized by underlying slowness and poverty of movements. There was also a strong trend towards reduction of symptoms of anxiety and depression in ACR16 treated patients and a marked improvement in performing the Trail Making test, a test for cognitive function.
Dr Joakim Tedroff, Chief Medical Officer at Carlsson Research stated “the results from this study are very encouraging and validates our drug discovery technology, ISP, in humans. We are particularly encouraged by the finding of reduced akinesia, a symptom strongly associated with functional decline in Huntington disease patients. This study supports our development approach for ACR16 in the disorder”.
Given the broad action of ACR16 in preclinical models, Carlsson Research believes ACR16 can be used as a symptomatic treatment for a number of symptoms associated with Huntington disease including motor and mental symptoms. Phase III studies will now be undertaken to bring the compound to the market.
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