A small biotech added a few hundred million dollars in market value Monday morning after announcing positive Phase III results from their lead neurology drug.
The drug, known as BXCL501, comes from BioXcel, one of a slate of biotechs that has raised millions in recent years on the promise of using artificial intelligence and other advanced computational techniques to speed up the sluggish pace of drug development. Similar to the more prominent Recursion, the company aimed to use its tech to find compounds that other companies or researchers had validated to some degree and repurpose them, particularly in the areas of neurodegeneration, mental health and immuno-oncology.
Now, in a pair of nearly 400-person Phase III trials for bipolar disorder and schizophrenia, the lead drug effectively calmed patients agitation, as measured by a standard scoring system. It also hit secondary endpoints, showing the effect began as early as 20 minutes after dosing.
The company said it plans to submit for approval in the first quarter of 2021. Their stock soared 31%, from $52.99 to $69.40 pre-market on the news.
In our view, these data are very compelling, Guggenheim Partners Yatin Suneja wrote in a note to investors, and we expect approval in both indications.
Suneja said the results looked in-line or better than Adasuve, the Alexza drug used as the standard of care for agitation. She predicted $500 million in peak sales.
When BioXcel filed for its IPO in 2017, though, the company spent as much time talking about its lead drugs potential in Alzheimers and dementia as it did about schizophrenia. Although further behind, that indication so sought out by biotech in recent years remains the companys largest market potential. A Phase I/II trial is now underway.
The larger focus for investors is dementia, larger market than schizophrenia/bipolar, SunTrusts Robyn Karnauskas wrote in a note to investors.
She said the Phase III numbers supported $800 million in peak sales, while pointing to even greater potential in neurodegeneration. We believe data helps validate targeting a central mechanism related to acute agitation and as such, should help expand BXCL501 into additional indications, she said.
That mechanism involves a reformulation of Pifzers 21-year-old sedation drug Precedex. BioXcel created a sublingual version of the drug that can be given easily and produce a calming effect without knocking a patient out. Specifically, it activated the alpha-2 receptor, the pathway through which norepinephrine, among other neuro-chemicals, travels.
In the Phase III studies, the drug reduced patients excitement score on the Positive and Negative Syndrome Scale for schizophrenia and bipolar disorder. Across 381 schizophrenia patients, those on the high dose had 10.3 point reduction after 2 hours, compared with 8.5 on the low dose and 4.8 on placebo. Across 378 bipolar patients, the high dose arm and 10.4 point reduction, compared with 9.1 on the low dose and 5 on placebo.
Patients also showed statistically significant improvements on the Agitation and Calmness Evaluation Scale (ACES), and clinical global impression.
Social image: Vimal Mehta, BioXcel CEO
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