REDWOOD CITY, Calif. - Jasper Therapeutics, Inc. (NASDAQ:JSPR) has announced preliminary results from its ongoing SPOTLIGHT Phase 1b/2a clinical trial, which is investigating the use of briquilimab for the treatment of chronic inducible urticaria (CIndU). The study focuses on adult participants with cold urticaria (ColdU) or symptomatic dermographism (SD), which are the most common subtypes of CIndU.
The initial data reveals that 14 of 15 participants achieved a clinical response within a six-week analysis period following the administration of briquilimab. In the 120mg dose cohort, 10 out of 12 participants experienced a complete response, and one participant had a partial response. The treatment was reported to be well-tolerated with no serious adverse events or grade 3 or higher adverse events reported.
Jasper has received regulatory clearance to enroll participants in a 180mg dose cohort as part of the study and expects to present full data from the SPOTLIGHT study in the first half of 2025. The company also anticipates reporting initial data from all cohorts of the BEACON study in chronic spontaneous urticaria (CSU) during the week of January 6th, 2025, which will include the 180mg Q8W dose cohort.
The SPOTLIGHT study is designed to evaluate the safety, tolerability, clinical activity, and pharmacokinetics/pharmacodynamics (PK/PD) of a single dose of subcutaneous briquilimab. The primary endpoints include safety and tolerability, while secondary endpoints focus on clinical activity and PK/PD, including measurements of serum tryptase and mast cells in the skin.
As of October 10, 2024, 15 participants had been enrolled and received a single dose of briquilimab, with all participants having at least six weeks of follow-up post-dosing. The study will enroll a total of 27 patients across three dose cohorts.
Jasper Therapeutics is developing briquilimab, a targeted monoclonal antibody therapy, for various chronic mast and stem cell diseases, including chronic urticaria and asthma, as well as a conditioning agent for stem cell transplants for rare diseases.
The company's announcement comes with the caveat that while the preliminary data is promising, the results are subject to further research and regulatory review. Jasper is set to provide more comprehensive data in the coming months, which will shed additional light on the efficacy and safety of briquilimab.
Investors and interested parties were informed that the details of the preliminary findings are based on a press release statement from Jasper Therapeutics.
In other recent news, Jasper Therapeutics has been making significant strides in its clinical trials, with Oppenheimer maintaining an Outperform rating on the company's shares. This outlook comes after the firm evaluated the long-term results from a Phase 2 study on barzolvolimab for Chronic Spontaneous Urticaria (CSU). The company has also been granted approval by Health Canada to commence a Phase 1b/2a clinical trial for briquilimab, a potential treatment for asthma.
In addition, the U.S. Patent and Trademark Office has registered a trademark for Jasper's proprietary Jasper c-Kit Mouse™ model. This has been instrumental in the clinical development of briquilimab. Several analyst firms, including JMP Securities, H.C. Wainwright, and RBC Capital, have assigned favorable ratings to Jasper Therapeutics, emphasizing the potential of briquilimab.
Jasper Therapeutics also announced that its SPOTLIGHT study in Chronic Inducible Urticaria and a trial for asthma are scheduled for the fourth quarter of 2024. Furthermore, Jasper is preparing for a proof-of-concept asthma challenge study, also slated for the same quarter. These developments demonstrate the biotech firm's progress in its clinical trials and the continued confidence of analysts in its future prospects.
InvestingPro Insights
As Jasper Therapeutics (NASDAQ:JSPR) reports promising preliminary results from its SPOTLIGHT clinical trial, investors may find additional context from InvestingPro's financial metrics and tips valuable.
According to InvestingPro data, Jasper Therapeutics has a market capitalization of $226.73 million, reflecting the market's current valuation of the company as it progresses through its clinical trials. The stock's performance has been volatile, with a significant 72.09% price return over the past year, despite a 34.02% decline in the last month. This volatility aligns with the nature of biotech companies advancing through critical clinical stages.
InvestingPro Tips highlight that Jasper holds more cash than debt on its balance sheet, which is crucial for a company in the resource-intensive phase of drug development. This financial cushion could provide the necessary runway to complete ongoing trials and potentially bring briquilimab to market.
However, investors should note that Jasper is currently not profitable, with an adjusted operating income of -$68.15 million over the last twelve months. This is typical for biotech companies in the development stage, and the success of briquilimab in trials like SPOTLIGHT could be pivotal for the company's future profitability.
Interestingly, three analysts have revised their earnings upwards for the upcoming period, suggesting growing optimism about Jasper's prospects. This could be influenced by the positive preliminary results from the SPOTLIGHT trial.
For those considering a deeper dive into Jasper Therapeutics' financial health and prospects, InvestingPro offers 11 additional tips, providing a more comprehensive analysis to inform investment decisions.
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