Spectral Medical Inc. is nearing completion of its Tigris trial, a confirmatory study evaluating Toraymyxin for treating endotoxemia and septic shock, while also reporting a 54% increase in revenue for the second quarter. The Canadian company's progress in the Tigris trial and strategic partnership with Baxter are key factors driving its growth and market potential.
Tigris Trial Progress
The Tigris trial is evaluating Toraymyxin, also known as polymyxin B hemoperfusion (PMX), in patients with endotoxemia and septic shock. This device removes endotoxin, a toxic substance produced by bacteria, from the bloodstream. As of recent updates, 126 patients have been randomized across 23 sites, with a target enrollment of 150 patients. The trial is expected to be completed by December 2024.
Spectral's CEO, Chris Seto, noted, "The potential to sustain our current pace of enrollment could see us rapidly advance the trial towards completion in the late 2024 timeframe. Additionally, with the receipt of gross proceeds of approximately $11m since the beginning of April, we have secured funding to finalise Tigris enrollment."
Financial Performance
For the second quarter, Spectral Medical reported revenue of $471,000, a 54% increase from $306,000 in the same period last year. While the company experienced a loss of $4.4 million ($0.02 per share), this was a slight decrease compared to the $4.2 million loss in Q2 of the previous year. The company's cash reserves have been bolstered by recent funding, with $7.5 million now available compared to just under $3 million at the end of 2023.
Strategic Partnership with Baxter
Spectral Medical is collaborating with Baxter for the post-approval marketing and commercialization of Toraymyxin. The two companies amended an existing agreement earlier this year, granting Baxter exclusive rights to supply and distribute PMX products for ten years following FDA marketing authorization.
"Baxter has communicated its intention to undertake a broad marketing campaign on day one of FDA approval for PMX," Spectral announced. The company is also working on a sub-study to obtain FDA clearance for hemoperfusion for Baxter’s Prismax device, anticipating it will be the primary intensive care unit (ICU) device used for PMX treatments.
Regulatory Status and Clinical Significance
Toraymyxin is already approved for therapeutic use in Japan and Europe and has been used safely and effectively on more than 340,000 patients to date. The device has also received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA), highlighting its potential to address the unmet need in treating endotoxic septic shock.
Spectral’s chief medical officer, Dr. John Kellum, stated, "We are committed alongside our trial sites to advancing Tigris and believe PMX, if ultimately approved, will play a major role in reducing the tragic rates of mortality caused by sepsis."
The Tigris trial is designed as a 2:1 randomized trial of 150 patients using Bayesian statistics to confirm the efficacy of PMX in addition to standard care versus standard care alone. Endotoxic septic shock remains a critical condition with high mortality rates, underscoring the importance of new therapeutic options like Toraymyxin.
