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Design Therapeutics Faces Setback in Clinical Study for DT-216 Drug


Shares of Design Therapeutics took a hit in post-market trading following the announcement of injection site reactions in patients participating in a phase 1 clinical study for its drug DT-216. DT-216 is intended to treat Friedrich ataxia, a degenerative disease. The stock experienced a 34% drop, reaching $4.81 at 6:55 p.m. EDT, with a potential decline of up to 42%. Over the course of the year, shares have declined by 29%, and in the last 12 months, the decrease amounts to 79%.

Design Therapeutics is a clinical-stage biotechnology company based in Carlsbad, Calif. The company specializes in developing treatments for degenerative genetic diseases. After the close of market trading, the company revealed that there were a total of five cases of injection site thrombophlebitis across all three cohorts participating in the study. Four cases were classified as mild, and one was considered moderate.

Thrombophlebitis is an inflammatory condition that leads to the formation of blood clots, which can block one or more veins. This information is sourced from the Mayo Clinic’s website. Despite these findings, Design Therapeutics has decided to continue developing DT-216 based on the study results.

The company, however, has chosen to complete dose escalation in this phase 1 study at the 300mg cohort due to concerns about potential worsening of injection site thrombophlebitis at higher doses and with multiple administration. Design Therapeutics will now shift its focus towards developing DT-216 with an improved formulation that allows for higher exposures and chronic intravenous administration to effectively treat Friedrich ataxia.

Friedrich ataxia is a rare inherited condition that damages the nervous system, leading to muscle weakness, balance issues, and sensory deficits. The Cleveland Clinic provides more information on this condition on its website.

In conclusion, Design Therapeutics is facing a setback in its clinical study for DT-216, as injection site reactions have been observed. However, the company remains committed to further developing the drug with an improved formulation for the treatment of Friedrich ataxia. Reports Strong Second-Quarter Results and Raises 2023 Guidance

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