LEHI, Utah, Nov. 12, 2026 /PRNewswire/ — Biolexis Therapeutics, Inc., a clinical-stage biotechnology company developing novel oral small-molecule therapeutics for metabolic disease, today announced that first-in-human Phase 1a data for BLX-7006 will be presented at ObesityWeek® 2026, November 14–17 in National Harbor, Maryland.

The placebo-controlled Phase 1a study (BLX-7006-CLN-001) enrolled 77 healthy adults across single ascending dose (SAD), food effect and multiple ascending dose (MAD) parts, evaluating doses of 25–150 mg, including once-daily dosing for seven days. BLX-7006 was generally well tolerated at all doses, with no serious adverse events, dose-limiting toxicities or treatment discontinuations.

A Differentiated Approach to GLP-1 Receptor Activation

Unlike conventional GLP-1 receptor agonists, which engage the orthosteric site used by native GLP-1, BLX-7006 binds a structurally distinct allosteric pocket near the receptor’s outer surface, as demonstrated by cryo-electron microscopy (cryo-EM). From this site, BLX-7006 promotes receptor activation and preferentially drives cAMP signaling with minimal β-arrestin recruitment. In preclinical in vitro studies, BLX-7006 also amplified signaling by endogenous GLP-1 and semaglutide, producing approximately threefold greater cAMP responses than either agonist alone at matched concentrations. This dual activity as a direct agonist and positive allosteric modulator may offer a differentiated approach to GLP-1 receptor activation, including potential complementary applications with existing therapies.

Key Phase 1a Clinical Findings

• Safety and tolerability: All treatment-related adverse events were mild or moderate (Grade 1 or 2), with no clinically meaningful trends in laboratory parameters, vital signs or ECGs.
• Gastrointestinal tolerability: Treatment-related nausea occurred in 4.2% of BLX-7006 SAD/MAD participants versus 5.9% on placebo, and diarrhea in 2.1% versus 5.9%, with no vomiting. In the seven-day MAD part, overall GI adverse events occurred in 20.8% of BLX-7006 participants versus 44.4% on placebo.
• Pharmacokinetics: BLX-7006 was rapidly absorbed (median Tmax approximately two hours), with approximately dose-proportional exposure, minimal accumulation over seven days, a 9–10-hour half-life and no clinically meaningful food effect, supporting further evaluation of once-daily oral dosing.
• Exploratory efficacy signals: BLX-7006 reduced two-hour post-dose glucose levels versus placebo. In the MAD part, the proportion of participants experiencing weight loss increased with dose, from 33% at 25 mg to 83% at 150 mg, compared with 38% on placebo. Mean body weight decreased in BLX-7006-treated participants and increased in placebo participants.

Poster Presentation Details

About BLX-7006

BLX-7006 is an investigational, orally available small-molecule GLP-1 receptor agonist with a structurally distinct allosteric mechanism. Building on encouraging Phase 1a findings, Biolexis is preparing to initiate a 12-week Phase 1b clinical study later this year in two populations: adults with obesity without type 2 diabetes and adults with obesity and type 2 diabetes. The study will further evaluate safety, tolerability and preliminary efficacy, including effects on body weight and glycemic control.

About Biolexis Therapeutics

Biolexis Therapeutics, Inc. is a clinical-stage biotechnology company based in Lehi, Utah, developing novel, orally administered small-molecule therapeutics for obesity and metabolic disease. Its clinical pipeline includes BLX-7006, a structurally distinct allosteric GLP-1 receptor agonist, and BLX-0871, a potentially first-in-class, γ3 isoform-selective AMPK activator being developed to preserve skeletal muscle mass and function, including during weight loss, and support broader metabolic health. Through differentiated and potentially complementary mechanisms of action, Biolexis aims to address important unmet needs in weight management, muscle preservation and metabolic disease. For more information, visit biolexistx.com.

Forward-Looking Statements

This press release contains forward-looking statements regarding the potential safety, tolerability, efficacy and therapeutic applications of BLX-7006 and BLX-0871; potential use alone or in combination with other therapies; and the timing, design and anticipated outcomes of future clinical studies. These statements are based on current expectations and involve risks and uncertainties, including those related to drug development, clinical results, regulatory review and financing, that could cause actual results to differ materially. Early clinical and preclinical findings may not predict outcomes in larger or longer-duration studies. Neither BLX-7006 nor BLX-0871 has been approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority. Biolexis undertakes no obligation to update these statements except as required by applicable law.

Website: biolexistx.com

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