MBX Biosciences' MBX 1416 Shows Positive Phase 1 Data In PBH; Stock Down In Pre-market

MBX Biosciences

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(RTTNews) - MBX Biosciences, Inc. (MBX) announced Tuesday positive results from its Phase 1 single ascending dose or SAD and multiple ascending dose or MAD clinical trial of MBX 1416 in healthy adult volunteers for the treatment of post-bariatric hypoglycemia or PBH.

In pre-market activity on the Nasdaq, the shares were down around 7.3 percent, after losing around 12.4 percent on Monday's regular trading.

The clinical-stage biopharmaceutical company, focused on precision peptide therapies for the treatment of endocrine and metabolic disorders, said it intends to discuss these results with the U.S. Food and Drug Administration in an End-of-Phase 1 meeting in mid-2025.

Pending alignment with the FDA, a Phase 2 study of MBX 1416 in patients with PBH is anticipated to initiate in the second half of 2025, the firm said.

PBH is a rare and serious complication of bariatric surgery, and characterized by repeated episodes of symptomatic hypoglycemia, triggered by exaggerated secretion of GLP-1 levels following a meal. It can present as early as six months after Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy.

MBX 1416 is the company's investigational long-acting glucagon-like peptide 1 (GLP-1) receptor antagonist, being developed for the treatment of PBH.

The Phase 1 clinical trial conducted in the United States was a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MBX 1416 in healthy adult volunteers.

The topline Phase 1 results showed MBX 1416 was generally well-tolerated with a favorable safety profile and a promising pharmacokinetic profile supportive of once-weekly dosing.

Kent Hawryluk, President and Chief Executive Officer of MBX Biosciences, said, "We also observed an apparent increase in GLP-1 peak during the first hour after a mixed meal tolerance test, which is an encouraging signal that we believe may translate into a therapeutic benefit in patients with PBH. Based on these results, we intend to initiate a Phase 2 study in patients with PBH in the second half of 2025 to further optimize dosing, pending alignment with the FDA on our proposed study design."

On Monday, MBX shares closed trading at $16.28, down 12.43 percent. In pre-market activity, the shares are currently at $15.10, down 7.25 percent.

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