PRODUCT PIPELINE
Our Clinical Pipeline
Neuroscience
BXCL501
KalmPenTM (Single-use IM)
BXCL502
Wearable Device (+BXCL501)**
Immuno-oncology
BXCL701
(small cell neuroendocrine carcinoma and adenocarcinoma)
**Regulatory path to be determined; device + drug combination to be evaluated after further evaluation of predictive algorithm
Opioid withdrawal symptoms with BXCL501 pending NIDA grant decision
Agitation in delirium study with BXCL501 is on voluntary pause
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.
BXCL501 is our most advanced neuroscience clinical program, currently being developed for the treatment of agitation associated with schizophrenia, bipolar disorders, dementia, depression and delirium and opioid withdrawal symptoms. As a selective adrenergic agent with a sublingual or buccal route of administration, BXCL501 is designed to be easy to administer and has demonstrated a rapid onset of action in clinical studies. BXCL501 is also designed to reduce agitation without producing excessive sedation or unarousable sleep. Managing a patient’s agitation or withdrawal symptoms represents a significant challenge for physicians and caregivers. BXCL501 has received Breakthrough Therapy designation for agitation associated with dementia and Fast Track designation by the FDA for agitation associated with schizophrenia, bipolar disorders and dementia.
The FDA has accepted for filing the New Drug Application for BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar I and II disorders, and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of April 5, 2022. The application is supported by data from the SERENITY I and II pivotal trials.
In early 2021, we announced positive topline results from the TRANQUILITY Phase 1b/2 trial for the acute treatment of agitation associated with dementia, including Alzheimer’s disease. Following discussions with the FDA in Q4 2021, we initiated our pivotal phase 3 program of BXCL501 for acute treatment of agitation in patients with Alzheimer’s disease. The Company also reported results from its RELEASE Phase 1b/2 trial for the treatment of opioid withdrawal symptoms.
BXCL701
BXCL701 currently has two ongoing combination therapy clinical trials. The Company is conducting a Phase 1b/2 trial of BXCL701 in combination with KEYTRUDA® (pembrolizumab) for metastatic castration-resistant prostate cancer (mCRPC), in patients with adenocarcinoma and in patients with the aggressive variant small-cell neuroendocrine carcinoma.. The trial will now continue to full enrollment and more complete efficacy data are expected to be presented at a scientific conference early next year.
The MD Anderson-led Phase 2 open-label basket trial was designed to evaluate the response rate of orallyadministered BXCL701, combined with KEYTRUDA, in two arms. Arm A is enrolling checkpoint naïve patients where checkpoint therapy is indicated (also referred to as “hot tumors”); and Arm B is enrolling patients who have progressed following checkpoint therapy alone. The Stage 1 efficacy bar was met for the checkpoint naïve patients, allowing Arm A of the trial to advance to completion. The Company plans to report an efficacy update from the trial in mid-2022.
