MBX Biosciences (MBX) announced the publication of a peer-reviewed article highlighting results from the Phase 1 study of MBX 2109, the Company’s parathyroid hormone peptide prodrug in development for the treatment of hypoparathyroidism. The publication, titled “MBX 2109, a Once-Weekly Parathyroid Hormone Replacement Therapy Prodrug: Phase 1, First-in-Human, Randomized Trial”, was published in The Journal of Clinical Endocrinology and Metabolism and can be accessed here. The publication features results from the multiple ascending dose portion of the Phase 1 study of MBX 2109, a peptide prodrug yielding a biologically active PTH agonist. The Phase 1 study was a randomized, double-blind, placebo-controlled trial designed to evaluate safety, pharmacokinetics, and pharmacodynamics of MBX 2109 in healthy adults. Forty participants were randomized 4:1 to receive four once-weekly subcutaneous doses of either placebo or MBX 2109 at 200, 400, 600, or 900 microgram. Key highlights from the publication: The observed half-lives of the prodrug and the active drug reflected the prodrug design and were supportive of once-weekly administration. Peak-to-trough exposures to the active drug with weekly dosing were relatively flat, with ratios ranging from 1.47 and 1.79 across dose levels. With weekly injections, dose-proportional increases in albumin-adjusted serum calcium and concomitant suppression of endogenous PTH were observed, consistent with the expected PTH pharmacology in healthy participants. Repeat doses of MBX 2109 were generally well-tolerated at all doses tested. Most treatment emergent adverse events were mild in severity. Injection-site reaction was the most common TEAE. No MBX 2109 dose-related serious or severe adverse events or deaths were reported.
Don't Miss our Black Friday Offers:
- Unlock your investing potential with TipRanks Premium - Now At 40% OFF!
- Make smarter investments with weekly expert stock picks from the Smart Investor Newsletter
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
See the top stocks recommended by analysts >>
Read More on MBX:
- MBX Biosciences completes last visit in Phase 1 MBX 1416 trial in hypoglycemia
- MBX Biosciences Reports Q3 2024 Financial Progress
- MBX Biosciences reports Q3 EPS ($2.78), consensus ($2.72)
- MBX Biosciences sees cash runway into mid-2027
- Opening Day: Another trio of biotech IPOs make Friday debut
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
