Acadia announces positive results of Phase 3 trial to treat psychosis
Category: #health  By Pankaj Singh  Date: 2019-12-06
  • share
  • Twitter
  • Facebook
  • LinkedIn

Acadia announces positive results of Phase 3 trial to treat psychosis

Acadia Pharmaceuticals, a renowned US-based biopharmaceutical company dedicated to the development of treatments for central nervous system disorders, reportedly announced positive outcomes from its Phase 3 HARMONY study of pimavanserin.

The company announced these positive outcomes during the 12th CTAD (Clinical Trials on Alzheimer’s Disease) meeting being held in San Diego, California between December 4 and 7, 2019.

HARMONY was a relapse prevention, double-blind, placebo-controlled trial in 392 patients for the evaluation of pimavanserin to treat dementia-related psychosis.

Director Emeritus of Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas, Jeffrey Cummings, M.D., Sc.D. stated that the outcomes showcased are a crucial advancement for caregivers and patients who struggle with the weight of dementia-related psychosis, a niche where there is no FDA-approved therapy currently available.  

Cummings further added that decreasing the threat of relapse of psychotic symptoms with this margin is a vital and meaningful result. This is because these are very serious events that could further lead to poor patient results and substantial growth in caregiver distress and burden.

The Phase 3 HARMONY trial comprised a 12-week open-label pimavanserin therapy period before the randomization period of the trial. During this open-label therapy period, 61.8% of eligible patients were able to reach to pre-specified criteria for pimavanserin therapy response at week 12 and week 8 both.

For patients in the open-label therapy period, alteration from baseline to week 8 and then to week 12 on the SAPS-H+D (Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions) score increased by 63.0% as well as 75.2% respectively.

President of ACADIA, Serge Stankovic, M.D., M.S.P.H., stated that the company is thrilled to unveil the top-line outcomes from this Phase 3 study to treat dementia-related psychosis. The HARMONY trial was innovated to get solutions for three very important problems. First, during the 12-week open-label period, treatment through pimavanserin indicated a meaningful decrease of the symptoms. Also, a reduction in the stabilization of psychosis through all the five clinically detected subtypes evaluated were seen.

Second, during the 26-week double-blind timeframe, patients dosed with pimavanserin had an almost three-fold decrease in risk of relapse in comparison with patients on placebo. Third, elderly patients suffering from dementia-related psychosis could tolerate pimavanserin well.

The company looks forward to discussing these outcomes with the FDA in the first half of the coming year.

 

 

Source credit: https://ir.acadia-pharm.com/news-releases/news-release-details/acadia-pharmaceuticals-presents-positive-top-line-results?field_nir_news_date_value%5bmin%5d=



About Author

Pankaj Singh

Email: [email protected]   

Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

Read More

More News By Pankaj Singh

US buys all of the global supply of Gilead’s COVID-19 drug remdesivir
US buys all of the global supply of Gilead’s COVID-19 drug remdesivir
By Pankaj Singh

While top-notch companies are racing to develop a vaccine for COVID-19, it looks like the United States has secured almost all of the world’s supply of interim drug remdesivir to treat patients with COVID-19.

...

Potential COVID-19 vaccine by Bharat Biotech to enter clinical trials
Potential COVID-19 vaccine by Bharat Biotech to enter clinical trials
By Pankaj Singh

Bharat Biotech International, a leading Indian biotechnology company, has reportedly announced that its potential coronavirus vaccine, Covaxin, has received Drug Controller General of India (DCGI) approval to start hum...

Seattle Genetics reveals positive data from tisotumab vedotin trial
Seattle Genetics reveals positive data from tisotumab vedotin trial
By Pankaj Singh

Seattle Genetics, Inc., a renowned biotechnology firm that focuses on developing antibody-based cancer treatments, has recently revealed positive topline data from its Phase 2 clinical trial (innovaTV 204) assessing ti...