Check-Cap shares soar on FDA IDE approval for pivotal C-Scan study
Mar. 15, 2021 8:23 AM ET
Check-Cap Ltd. (CHEK)
- Check-Cap(NASDAQ:CHEK)shares more than doubled during premarket tradingafter the company receivedapproval from the U.S. FDA for itsInvestigational Device Exemption (IDE) application, permitting it to begin a pivotal study of C-Scan in the U.S.
- C-Scan is intended for candidates who are at average-risk for colorectal cancer (CRC) and who are poor candidates for colonoscopy or decline colonoscopy, or who had an incomplete optical colonoscopy.
- The company said that it is actively in discussions with a number of clinical sites as part of its preparations to begin the pivotal study in late 2021.
- It is also gearing up to initiate a study in Israel at more than 10 clinical sites to enroll up to 250 average risk patients.
Here comes the Stoney 8:30 Monday morning stock blitz.
This is where we get 20 stocks and Stoney pays no attention to anything else.
OK STONEY...
You have to look at this one. Dementia has a huge market.
This company also has about 25% of its float shorted.
BTAI
Its up pre-market on this news:
BioXcel Therapeutics Receives FDA Breakthrough Therapy Designation for BXCL501 for the Acute Treatment of Agitation Associated with Dementia
Download as PDF March 15, 2021
Designation offers the potential for expedited development and review, highlighting the urgent need for new treatment options for dementia related agitation
NEW HAVEN, Conn., March 15, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. ("BioXcel" or the "Company") (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that BXCL501, the Company's investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine ("Dex"), has been granted Breakthrough Therapy designation from the U.S. Food and Drug Administration ("FDA") for the acute treatment of agitation associated with dementia. The Breakthrough Therapy designation is intended to expedite the development and review of certain product candidates designed to treat serious or life-threatening diseases or conditions, and the designation includes increased interaction and guidance from the FDA.
“Managing dementia related agitation, specifically in elderly patients, represents a significant challenge for physicians and caregivers, as there are currently no FDA-approved therapies and off-label drugs come with black box warnings," stated Vimal Mehta, Chief Executive Officer of BioXcel. "The FDA's decision to grant Breakthrough Therapy designation further underscores the significant unmet need for a new treatment for this underserved patient population, as well as highlights BXCL501’s potential in becoming the first therapeutic option, if approved, to address this debilitating medical condition. We look forward to working closely with the FDA to advance BXCL501 into a pivotal dementia program, in hopes of quickly bringing this therapy to the millions of patients across treatment settings that lack alternative options.”
The Breakthrough Therapy designation for BXCL501 was supported by the positive topline data from the Phase 1b/2 TRANQUILITY study for the acute treatment of agitation associated with dementia, including Alzheimer's disease. BXCL501 demonstrated statistically significant reductions in agitation measures at 2 hours post-dose with both the 30 and 60 mcg doses as measured by multiple scales. The dose dependent response observed has the potential to support the Company’s plans to evaluate BXCL501 for use across the full range of dementia care settings.
About FDA Breakthrough Therapy Designation
Breakthrough Therapy designation is an FDA program intended to expedite the development and regulatory review of investigational therapies that are designed to address serious or life-threatening conditions. The criteria for Breakthrough Therapy designation requires preliminary clinical evidence that indicates that the candidate may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. This designation provides the Company with more intensive FDA guidance on an efficient drug development program, and eligibility for other actions to expedite the FDA review, such as a rolling review of a New Drug Application (“NDA”), where the FDA may review sections of the NDA before the complete application is submitted. An NDA for a product candidate receiving breakthrough designation may also be eligible for priority review if the relevant criteria are met. Breakthrough Therapy designation does not change the standards for approval. For more information, please visit the FDA website at
www.fda.gov.
About Dementia Related Agitation
Dementia is a neurocognitive condition caused by damage to brain cells that leads to a decline in cognitive abilities and independent function. It affects approximately 6 million individuals in the United States, with Alzheimer's disease accounting for up to 80% of these cases. During the course of the disease, patients with dementia often suffer from psychological and behavioral symptoms, such as agitation, which has been reported in up to 70% of patients. Agitation associated with dementia can negatively affect both the patient and caregiver's quality of life. Caregiver burden can contribute significantly to burnout, which can result in premature institutionalization of the patient. Treating agitation associated with dementia has been a challenge for providers as there are currently no FDA-approved therapies for the treatment of dementia-related agitation, and off-label therapies have black box warnings associated with their use.
About BXCL501
BXCL501 is an investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine, a selective alpha-2a receptor agonist for the treatment of agitation and opioid withdrawal symptoms. BioXcel believes that BXCL501 potentially targets a causal agitation mechanism, and the Company has observed anti-agitation results in multiple clinical studies across several neuropsychiatric disorders. BXCL501 has been granted Fast Track Designation by the U.S. Food and Drug Administration for the acute treatment of agitation in patients with schizophrenia, bipolar disorders, and dementia. BXCL501 has been studied in two Phase 3 trials (SERENITY I and II) for the acute treatment of schizophrenia related agitation and bipolar disorder related agitation, respectively, and in a Phase 1b/2 trial (TRANQUILITY) for the acute treatment of dementia related agitation. This product candidate is also currently being evaluated in a Phase 1b/2 trial (RELEASE) for the treatment of opioid withdrawal symptoms and in a Phase 2 trial (PLACIDITY) for the treatment of delirium related agitation.
BioXcel Therapeutics, Inc.
BioXcel Therapeutics, Inc. is a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology. BioXcel's drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices. BioXcel's two most advanced clinical development programs are BXCL501, an investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine for the treatment of agitation and opioid withdrawal symptoms, and BXCL701, an investigational, orally administered, systemic innate immunity activator in development for the treatment of aggressive forms of prostate cancer and advanced solid tumors that are refractory or treatment naïve to checkpoint inhibitors. For more information, please visit
www.bioxceltherapeutics.com.
