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

 

  • shareshare_icon
  • Twitter
  • Facebook
  • LinkedIn


About Author

Nikita Chaurasia     twitter

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

Arm Holdings achieves $54.5 Billion Valuation in successful U.S. IPO

Arm Holdings achieves $54.5 Billion Valuation in successful U.S. IPO

By Nikita Chaurasia

Arm Holdings Plc, the renowned chip designer, has reportedly secured a valuation of $54.5 billion through its U.S. initial public offering (IPO) on Wednesday. This milestone comes seven years after its acquisition by SoftBank Group Corp for $32 billi...

JSW Steel to increase its capacity by double in the next 3 years

JSW Steel to increase its capacity by double in the next 3 years

By Nikita Chaurasia

According to Chairman Sajjan Jindal, JSW Steel has set a target to increase its capacity to 50 million tonnes within the next three years. Speaking at an event organized by the Bombay Chartered Accountants Society, Jindal also mentioned the company&#...

KLM unveils World Business Class Seats for optimal comfort & privacy

KLM unveils World Business Class Seats for optimal comfort & privacy

By Nikita Chaurasia

KLM Royal Dutch Airlines has reportedly unveiled its latest World Business Class seats, designed to provide enhanced comfort and privacy. The World Business Class seats feature a sliding door, ensuring a greater sense of personal space. Additional...