New York, February 13, 2024 - PRISM MarketView - PRISM MediaWire - Biopharmaceutical company, BioXcel Therapeutics, Inc. (Nasdaq: BTAI), has been granted FDA Fast Track designation for BXCL701 in combination with a CPI for the treatment of patients with metastatic small cell neuroendocrine prostate cancer (SCNC).
“The FDA’s Fast Track designation for the investigation of BXCL701 in SCNC is an important recognition of our most advanced immuno-oncology asset and an acknowledgment of its potential to address the considerable unmet medical need in these patients. At the same time, it further validates the unique AI-based drug re-innovation approach that we used to discover this asset. BXCL701 has already demonstrated considerable potential in our clinical trials to date.”
Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics
Highlights
This year, nearly 300,000 men will be diagnosed with prostate cancer in the US, according to the American Cancer Society. Approximately 20% of these men are expected to progress to the more aggressive metastatic castration-resistant form, including an estimated 11,960 patients expected to progress to SCNC.
SCNC is characterized by poor prognosis and a low survival rate, and current treatment options are suboptimal. BXCL701 has demonstrated clinical proof of concept in both SCNC and adenocarcinoma.
BioXcel reported positive survival results from a Phase 2 trial late last year and is planning to discuss the registration path for BXCL701 at an upcoming meeting with the FDA.
The FDA grants Fast Track designation to facilitate the development and expedite the review of medicines to treat serious conditions, fill unmet medical needs, and bring promising medicines to patients more quickly.
About BioXcel Therapeutics, Inc.
BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience. Its wholly owned subsidiary, OnkosXcel Therapeutics, is focused on the development of medicines in immuno-oncology. The Company’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 indications. For more information, please visit bioxceltherapeutics.com.
PRISM MarketView does not provide investment advice.
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