By Chris Wack
Cartesian Therapeutics said its phase 2b trial of Descartes-08 in patients with a chronic autoimmune disorder met its main goal.
Descartes-08 achieved its primary endpoint with statistical significance in a pre-specified population of patients with generalized myasthenia gravis, with 71% of patients showing five-point or greater improvements in a score measuring measure the disease's severity and impact at three months of treatment, compared with 25% of patients treated with placebo.
The trial also met its primary endpoint with statistical significance in the per-protocol population, with 69% of patients treated with Descartes-08 seen with a five-point or greater improvements in the score measuring disease severity and impact at three months, compared with 33% of patients treated with placebo.
Cartesian also said that two patients enrolled in the phase 2a open-label portion of the trial saw rapid improvement in clinical scores and maintained minimal symptom expression for up to one year after receiving a second treatment cycle.
Descartes-08 is Cartesian's lead product candidate designed to be administered as an outpatient treatment. The drug was previously granted regenerative medicine advanced therapy designation and orphan drug designation by the U.S. Food and Drug Administration to treat myasthenia gravis.
The clinical-stage biotechnology company also said it entered into a securities purchase agreement for a private investment in public equity financing that is expected to result in proceeds of $130 million. The PIPE financing is expected to close on or about Wednesday.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
July 02, 2024 07:26 ET (11:26 GMT)
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