Our Clinical Pipeline
Acute treatment of agitation associated with Alzheimer’s disease*
KalmPenTM (Single-use IM)
Wearable Device (+BXCL501)**
(small cell neuroendocrine carcinoma and adenocarcinoma)
The safety and efficacy of investigational agents and/or investigational uses of approved products have not been established
*Includes intermittent chronic
**Regulatory path to be determined; device + drug combination to be evaluated after further evaluation of predictive algorithm
Pipeline as of April 5, 2022
BXCL501 is our most advanced neuroscience clinical program. BXCL501 is a proprietary, sublingual film formulation of dexmedetomidine, a selective alpha-2 receptor agonist. It is being investigated as an acute treatment for agitation in Alzheimer’s disease, and as an adjunctive treatment for major depressive disorder.
BXCL501 has received Breakthrough Therapy and Fast Track designation for the acute treatment of agitation associated with dementia. In 2021, the Company 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 has also submitted an Investigational New Drug (IND) application to evaluate BXCL501 as adjunctive treatment for major depressive disorder (MDD).
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.