Safety Issue Trips Third Harmonic Months After IPO

Courtesy Shutterstock

Courtesy Shutterstock

Third Harmonic Bio drops its Phase 1b asset.

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Third Harmonic Bio, Inc, a clinical-stage biopharmaceutical company developing a potent, highly selective, oral KIT inhibitor for severe inflammatory diseases, announced Thursday it would discontinue Phase Ib testing for its lead asset THB001.

THB001 was being trialed as a potential treatment for a common inflammatory skin condition known as chronic inducible urticaria. Although the drug exhibited pharmacodynamic and clinical activity in preliminary analyses, Third Harmonic’s management decided to discontinue its Phase Ib study after two patients presented with asymptomatic liver transaminitis.

In the wake of this disappointing clinical update, Third Harmonic announced it would provide an overall corporate strategy and outlook in early 2023. The drugmaker’s stock price fell by as much as 75% Thursday in response to this news.

“While this is a deeply disappointing outcome, we are encouraged by the preliminary signs of clinical activity at this starting dose and are optimistic about the potential for a selective oral wild-type KIT inhibitor to become an important treatment modality for mast cell-driven inflammatory diseases,” Natalie Holles, chief executive officer of Third Harmonic Bio said in a prepared statement.

A Soft Year for Biotech IPO’s

Despite a soft macroeconomic outlook and rising interest rates, Third Harmonic decided to go public in September. What’s noteworthy about this decision is that only a handful of biotech and biopharma companies have followed through on their plans to go public in 2022.

At the midway point through 2022, for example, a mere 16 life sciences companies had gone public. By comparison, 68 life sciences companies had done so over the first half of 2021.

The tough economic conditions, coupled with the ongoing bear market for cash flow negative companies, have kept most life sciences companies in the private sphere this year.

Third Harmonic’s unexpected clinical setback probably won’t help matters. This clinical setback will likely serve as yet another reminder to already nervous investors that early developmental biotech equities are a high-risk proposition.

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