What happened
The shares of biotech Sorrento Therapeutics (SRNE.Q -14.29%) ended the week on a high note, rising a bit over 1% on Friday. The catalyst was some encouraging clinical news from a subsidiary.
So what
Sorrento announced on Friday morning that Scilex Holding, a business that it has a majority share in, had shown promising results with a pipeline drug.
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That drug is Semdexa, which was being tested for sciatica pain management. Sorrento said that in a phase 3 trial, Semdexa demonstrated "highly statistically significant improvement," over a placebo across the first four weeks after treatment. It also demonstrated continued reduction of pain after one month.
The drug also demonstrated a "very clean safety profile," Sorrento said, with no identified safety risks or serious adverse events.
Semdexa also met its key secondary endpoint, as patients showed a 28% improvement compared to baseline on the Oswestry Disability Index. This is a measure of disability and quality of life, and its minimal clinically meaningful improvement over baseline is 8% to 12%.
Now what
In its press release, Sorrento said, "Scilex intends to use the results from this pivotal Phase 3 trial to discuss with the [Food and Drug Administration] in 2022 licensure application requirements and Breakthrough Designation Status for the high unmet need sciatica indication for which no treatments have been approved in the U.S."
Sorrento added that it aims to file a New Drug Application with the pharmaceutical industry regulator.
The trial results were certainly encouraging, particularly given that Semdexa is a non-opioid treatment and thus does not carry the risks associated with that class of medicines. It should stand a good chance of winning FDA approval.
