Jasper Therapeutics Faces Setback in Urticaria Drug Trial, Announces Restructuring

Jasper Therapeutics, a biotech company focused on developing novel therapies, has encountered a significant obstacle in its clinical trial program for briquilimab, its promising urticaria drug candidate. The company has reported confounding results from a recent phase 1/2 study, attributing the issue to a problematic drug product batch. This development has led to a series of strategic decisions, including a potential corporate restructuring and the halting of certain research programs.

Clinical Trial Setback

The phase 1b/2a study of briquilimab in adults with chronic spontaneous urticaria (CSU) initially showed promise, with all 12 patients in the 180-mg dose cohort achieving a clinical response. However, the higher dose cohorts revealed unexpected results. While seven of nine patients across the 240 mg and 360 mg single-dose cohorts achieved a clinical response by week 2, a group of 13 patients receiving either 240 mg every eight weeks or an initial 240 mg dose followed by 180 mg every eight weeks showed confounding results.

Jasper Therapeutics identified that 10 patients who received briquilimab from a specific drug lot experienced "lower than expected" drops in mean tryptase levels and "no discernable impact" on urticaria activity. In contrast, two patients from the affected cohorts who received briquilimab from a different drug lot both achieved a complete response.

CEO Ronald Martell expressed disappointment but remained committed to resolving the issue: "We are currently investigating the cause and are taking steps to ensure that drug product from the lot in question is returned to the company and that sites have drug product from other lots to continue dosing."

Strategic Decisions and Restructuring

In light of these developments, Jasper Therapeutics has announced several strategic decisions:

1. Halting the asthma program: The company discovered that the same problematic drug product had been used in a separate ongoing study of briquilimab in asthma, leading to the decision to pause development in this indication.

2. Discontinuing SCID research: Jasper is halting development in severe combined immunodeficiency (SCID).

3. Potential restructuring: The company is considering a restructuring to conserve cash and extend its runway.

4. Continued focus on CSU: Despite setbacks, Jasper plans to enroll an additional 10-12 patients across the two impacted cohorts to inform final dose selection for the phase 2b study in chronic spontaneous urticaria.

Martell stated, "We will be implementing a number of cost-cutting measures to reduce burn and extend our cash runway in light of this delay."

Market Response

The news has had a significant impact on Jasper Therapeutics' stock price. In pre-market trading on Monday, the company's stock plummeted 65% to $2.38 from a Thursday closing price of $6.77, reflecting investor concerns about the trial setback and potential restructuring.

As Jasper Therapeutics navigates these challenges, the pharmaceutical industry will be closely watching the company's next steps and the outcomes of its investigation into the problematic drug batch.