BioXcel begins Phase 3 BXCL501 trial for treating SCZ & bipolar disorder
Category: #health  By Nikita Chaurasia  Date: 2019-12-31
  • share
  • Twitter
  • Facebook
  • LinkedIn

BioXcel begins Phase 3 BXCL501 trial for treating SCZ & bipolar disorder

BioXcel Therapeutics, Inc., a clinical-stage biopharmaceutical firm leveraging artificial intelligence approaches to advance the next wave of medicines in immuno-oncology and neuroscience, has reportedly announced the initiation of its SERENITY program, two Phase 3 studies of BXCL501 for treating agitation in patients who are suffering from bipolar disorder and Schizophrenia.

According to Vimal Mehta, CEO of BioXcel, the beginning of the SERENITY clinical trials represented a crucial next step in the company’s aim to offer effective and safe therapy to millions of people who are suffer from agitation related to schizophrenia and bipolar disorder.

Mehta claims that managing agitation in patients suffering from neuropsychiatric disorders is a key challenge for both caregivers and physicians. Meanwhile, sources suggest that this treatment would provide calming with excessive sedation while protecting the caregiver-patient relationship.

For the record, the SERENITY studies are double-blinded, randomized, placebo-controlled, adaptive trials of up to 750 patients ranging from 18 to 75 years of age. The primary endpoint of these trials is reduced acute agitation measured by the Positive and Negative Syndrome Scale, analyzing the Excited Component (PEC) variation from baseline compared to placebo.

A key secondary endpoint comprises ascertaining the quickest time where an agitation effect is apparent as calculated by the variation from baseline in PEC score.

It is estimated that around 19 million people are at risk of agitation and 8.3 million people in the United States suffer from agitation every year, costing approx. $40 billion annually in treatment-related expenses.

As a potential treatment, BXCL501 is a first-in-class, trademarked sublingual thin film of selective alpha-2a receptor dexmedetomidine agonist for treating acute agitation. It is projected that topline data from these clinical trials are expected in mid-2020. Meanwhile, following this announcement, shares of BioXcel were reported up 9% premarket.
 

Source Link - https://www.bioxceltherapeutics.com/news-media/press-releases/detail/107/bioxcel-therapeutics-announces-initiation-of-pivotal-phase

 

  • share
  • Twitter
  • Facebook
  • LinkedIn


About Author

Nikita Chaurasia    

Nikita Chaurasia

Having always been daft at wordplay, Nikita Chaurasia, post the completion of post-graduation, commenced her journey into the content generation cosmos. Endowed with a professional MBA degree in Advertising and Public Relations, Nikita strives to integrate her creativ...

Read More

More News By Nikita Chaurasia

Syndax Pharmaceuticals reveals data from phase 1 trial of axatilimab
Syndax Pharmaceuticals reveals data from phase 1 trial of axatilimab
By Nikita Chaurasia

According to reliable sources, Massachusetts-headquartered clinical stage biopharmaceutical company, Syndax Pharmaceuticals Inc. has revealed an updated data from its Phase 1 trial of its patent axatilimab. The company will reportedly present the dat...

Xiaomi shares drop by 7.1% after raising USD 3.9 billion in equity deal
Xiaomi shares drop by 7.1% after raising USD 3.9 billion in equity deal
By Nikita Chaurasia

Shares of Xiaomi Corporation, a Chinese multinational electronics company, witnessed a 7.1% drop during Hong Kong trading after the company secured USD 3.91 billion in fund raising which also included the city’s top-up placement. The company h...

Supercom signs a supply contract of PureSecurity EM suite in Wisconsin
Supercom signs a supply contract of PureSecurity EM suite in Wisconsin
By Nikita Chaurasia

Israel-based leading provider of advanced solutions for cybersecurity, IoT (Internet of Things) and e-Government sectors Supercom has reportedly signed a supply agreement to deliver its PureSecurity EM (Electronic Monitoring) product suite in Wiscons...