MBX 1416 shows promise in Phase 1 trial for hypoglycemia treatment

CARMEL, Ind. - MBX Biosciences, Inc. (NASDAQ:MBX), a clinical-stage biopharmaceutical company with a market capitalization of $544 million, announced positive results from its Phase 1 clinical trial of MBX 1416, a drug candidate for treating post-bariatric hypoglycemia (PBH). According to InvestingPro data, the company maintains a strong financial position with more cash than debt and a "GOOD" overall financial health rating. The trial, which tested the safety and pharmacokinetics of the drug in healthy volunteers, supports the progression to a Phase 2 study expected to commence in the second half of 2025.

The study found MBX 1416 to be generally well-tolerated with a favorable safety profile, with no serious adverse events related to the drug observed. The majority of treatment-emergent adverse events were mild or moderate. Injection site reactions, mostly characterized by erythema, were common but resolved within approximately seven days.

Pharmacokinetic results showed that MBX 1416 concentrations increased dose-proportionally and supported once-weekly dosing, with a median half-life of approximately 90 hours. The drug also demonstrated an increase in GLP-1 levels within 60 minutes after a mixed meal tolerance test, indicating a potential pharmacodynamic effect that may benefit PBH patients.

The Phase 1 trial was a randomized, double-blind, placebo-controlled study conducted in the United States with 69 subjects. It evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of MBX 1416. The company's stock, currently trading at $16.28, is near its 52-week low, and InvestingPro analysis suggests the stock may be undervalued based on its Fair Value assessment. Discover more insights and 8 additional ProTips with an InvestingPro subscription. The trial included single ascending dose and multiple ascending dose cohorts, as well as a cohort to evaluate drug-drug interactions, with no meaningful effect on rosuvastatin exposure noted.

MBX Biosciences plans to discuss the Phase 1 results with the U.S. Food and Drug Administration (FDA) in a meeting scheduled for mid-2025. Pending FDA alignment, the Phase 2 study in PBH patients will be initiated. Analysts maintain a strong bullish stance on the company's prospects, with price targets ranging from $30 to $44. The company's next earnings report is scheduled for February 26, 2025. Track real-time updates and comprehensive analysis with InvestingPro.

PBH is a rare and serious complication of bariatric surgery, marked by severe hypoglycemia episodes that can significantly impact daily life. Currently, there are no approved pharmacotherapies for PBH, and the incidence is expected to rise with the increasing use of surgery for metabolic conditions.

The company held a conference call today to discuss the results from the MBX 1416 Phase 1 trial. The information shared in this article is based on a press release statement from MBX Biosciences, Inc.

In other recent news, MBX Biosciences successfully completed its Phase 1 trial for MBX 1416, a potential treatment for post-bariatric hypoglycemia. The trial, which involved 69 participants, aimed to evaluate the drug's safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy adults. Results from the trial are anticipated to be shared in early January 2025.

In addition, investment firms have shown considerable interest in the company. JPMorgan initiated coverage of MBX Biosciences with an Overweight rating, while Jefferies, Guggenheim, and Stifel all initiated coverage with Buy ratings. These ratings are based on the potential of MBX Biosciences' lead assets, MBX 2109 and MBX 1416, and the company's proprietary Precision (PEP) platform.

Moreover, MBX Biosciences is currently conducting a Phase II trial for MBX 2109, with results expected in the third quarter of 2025. The company also plans to advance MBX 4291 into clinical trials for obesity by next year. These recent developments are seen as opportunities for longer-term value creation and could further validate MBX Biosciences' proprietary PEP platform.

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