CAMBRIDGE, Mass. - Synlogic, Inc. (NASDAQ:SYBX), a clinical-stage biopharmaceutical company, has announced the publication of a study demonstrating the safety and mechanism of SYNB1353, a therapeutic candidate for classical homocystinuria (HCU), in preclinical models and a healthy volunteer study. The findings, published in the peer-reviewed journal Cell Host & Microbe, show that SYNB1353 effectively degrades methionine, a precursor to homocysteine, potentially lowering homocysteine levels in patients with HCU.
The study revealed that SYNB1353 was well-tolerated, with gastrointestinal adverse events being the most common side effect, reported similarly in both the active and placebo groups. Mylène Perreault, Ph.D., Head of Research at Synlogic, expressed optimism about the potential of SYNB1353, which builds on the company's experience with other rare metabolic disease programs.
Classical homocystinuria is a rare metabolic disorder characterized by high levels of homocysteine due to a deficiency in the cystathionine beta-synthase enzyme. This condition can lead to severe complications, including thromboembolic events and neurocognitive impairments. Current treatment primarily involves a restrictive diet low in methionine.
SYNB1353, developed in collaboration with Ginkgo Bioworks, is the first investigational medicine from Ginkgo's platform to enter clinical trials. The drug candidate has received Rare Pediatric Disease Designation, Fast Track designation, and Orphan Drug Designation from the U.S. Food and Drug Administration for the potential treatment of HCU.
Synlogic's focus on rare metabolic diseases includes its lead program, labafenogene marselecobac (SYNB1934), in a Phase 3 study for phenylketonuria (PKU), and SYNB1353 for HCU. The company's pipeline also explores treatments for conditions such as enteric hyperoxaluria, gout, cystinuria, and inflammatory bowel disease.
The information in this article is based on a press release statement from Synlogic, Inc.
InvestingPro Insights
As Synlogic, Inc. (NASDAQ:SYBX) advances its clinical trials, investors and industry watchers closely monitor the company's financial health and stock performance. According to InvestingPro data, Synlogic has a market cap of 31.52 million USD, reflecting its position in the biopharmaceutical landscape. The company's aggressive share buyback strategy, as highlighted in one of the InvestingPro Tips, suggests management confidence in the company's value proposition. Another key metric to consider is the company's cash position relative to its debt, which is a strength as Synlogic holds more cash than debt on its balance sheet.
While Synlogic does not pay dividends, which might be a factor for income-focused investors, its high shareholder yield is a positive sign for those looking for potential capital gains. However, it's worth noting that analysts do not anticipate the company will be profitable this year, and the stock has experienced significant volatility with a 74.15% decline over the last year and a recent 3-month price total return of 91.76%. For those interested in exploring more about Synlogic, investing.com/pro/SYBX offers additional insights, including 14 more InvestingPro Tips for a comprehensive analysis.
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