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Positive Results from BXCL501 Trial Offers Hope to Patients with Schizophrenia related Agitation

25 Jul Positive Results from BXCL501 Trial Offers Hope to Patients with Schizophrenia related Agitation

BioXcel Therapeutics (NASDAQ: BTAI) is buoyed by the positive results from a Phase 1b clinical trial, to test the efficacy of BXCL501, its lead drug candidate for the treatment of agitation in patients suffering from Schizophrenia. The drug candidate was granted a fast track designation by the FDA in December 2018.

Dr. Vimal Mehta Ph.D., Chief Executive Officer of BioXcel Therapeutics comments

“These very encouraging data provide supportive evidence regarding BXCL501’s potential to treat agitation in patients with schizophrenia and additionally, provides support for the drug’s broad potential across multiple neuropsychiatric disorders,” 

The usage of the drug has shown a reduction in the PEC score (Profile of Emotional Competence), a key measure for agitation. Further it was observed that the drug provided rapid calming without excessive sedation at two hours, when patients were administered three varied doses of 80 mcg, 120 mcg and 180 mcg doses of BXCL501 as compared to a placebo.

The study also evaluated the calming effect using ACES (Agitation-Calmness Evaluation Scale), and met statistical significance for calming, as measured by ACES at two hours. It was well tolerated without any adverse events, except for minor side effects such as mild drowsiness and dry mouth.

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Professor John Krystal, MD, Chairman, Department of Psychiatry, Yale University School of Medicine, states

The BTI Phase 1b data suggest that BXCL501, rapidly and non-invasively calmed agitated schizophrenia patients without requiring intramuscular administration and without producing excessive sedation. If successfully developed and approved, BXCL501 could offer psychiatrists and Emergency Medicine physicians a new tool for treating agitation in their patients.”

Backed with these results, the company is now planning to launch its pivotal Phase 3 trials, in consultation with the FDA.

Schizophrenia is defined as a mental disorder in which there are disturbances in thought (Delusions), perceptions (hallucinations), behavior (disjointed speech) and social interactions. It is one of the leading causes of disability worldwide. In U.S alone mental and behavioral disorders account for 13.6 percent of total DALY’s (Disability-adjusted life years) according to the statistics released by National Institute of Mental Health.

Schizophrenia is characterized by symptoms such as failure to distinguish between perception and reality, hallucinations which are visual (Seeing people), Auditory (Hearing voices), or related to taste, touch and the sense of smell. Some patients suffer from delusions related to being persecuted or being victimized, while other may experience sexual and religious delusions. In addition, their speech does not follow any logic or exhibits incoherent thoughts, leading to social withdrawal, reticence, lack of self-care, emotionally distant behavior and lack of motivation.

The treatment for schizophrenia is life-long, even when the symptoms have reduced. Anti-Psychotic drugs, that can control dopamine and glutamate, are the most preferred course of medication. These are usually combined with psychosocial therapy (family therapy, individual counseling, rehabilitation and employment support) and other drugs such as antidepressants and anti-anxiety medication. However, the medications used for treatment of these symptoms have some significant side-effects such weight gain or loss, changes in vision, severe headaches, light-headedness or breathlessness, erratic mood swings, insomnia , loss of appetite, spasms, stiffness, twitches and tics, issues with sexual health.

Research shows that a whopping 86.19% of people experience at least one of the above mentioned side affects prompting them to stop taking medication. Only 42.5% of the patients reported total adherence to the medication. These side effects prevent people from taking their medication diligently, thereby leading to worsening of symptoms overtime.

Agitation is a common condition observed in those suffering from psychiatric disorders such as schizophrenia and bipolar disorder. In the absence of effective therapeutic options, physical restraint and seclusion are the only options available to control aggression that stems out of agitation. Over 19 million people are at risk, and 8.3 million in the U.S. suffer from agitation each year as per a statement by BioXcel.

BioXcel Therapeutics leverages the power of Artificial Intelligence to create novel therapeutics for the treatment of unmet conditions in the fields of neuroscience and immuno-oncology. The company uses proprietary machine learning algorithms to re-engineer existing approved drugs or clinical drugs to identify new therapeutic possibilities.

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BXCL501, its lead candidate for the treatment of agitation, is a selective alpha 2a receptor agonist and a potential first-in-class proprietary sublingual thin film of dexmedetomidine. It has proven to be safe, well –tolerated and effective in calming agitation in schizophrenia in various clinical trials. The company intends to test its application in other indications such as agitated dementia, opioid withdrawal symptoms and hyperactive delirium in the future.

InveniAI and PharmaGPS, are the company’s Artificial Intelligence and Big Data driven analytics platforms. They apply machine learning to identify the hidden interplay between diseases, molecular targets and drugs, and offer improved therapeutics from existing drugs or create novel drugs.

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The company’s pipeline consists of candidates for the treatment of diverse indications such as pancreatic cancers, hematological malignancies, neurodegeneration and oncology.

BioXcel has strategic partnerships with specific focus on de-novo drug discovery, drug re-innovation, asset rescue, indication expansion, life-cycle management, and product reformulation opportunities. Some of its clients include Alnylam (NASDAQ: ALNY), Axcella (NASDAQ: AXLA), Centre Therapeutics and Takeda (NYSE: TAK).

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