MBX Advances Phase 3 Trial as Research Spending Climbs
The biotechnology company held $418.6 million in cash and securities, funding operations into 2029.
MBX Biosciences (MBX), a clinical-stage biopharmaceutical company developing peptide therapies, began recruiting for canvuparatide’s Phase 3 trial, activating sites and screening participants ahead of planned first-patient dosing in the third quarter.
The trial’s progression marked a step forward from MBX’s June update, when the company said the program was on track to start during the quarter. One-year data showed a 57% responder rate, compared with 63% at 12 weeks, while 90% of patients who entered the open-label extension remained enrolled at one year. There were no new safety signals or treatment-related serious adverse events.
The quarterly net loss widened 91% to $37.1 million from $19.4 million a year earlier as MBX invested in clinical development and expanded its organization. Research-and-development expense rose 75% to $31.0 million, driven by canvuparatide Phase 3 start-up costs, its Phase 2 extension, the MBX 4291 Phase 1 trial and preclinical work on MBX 5765.
General-and-administrative expense increased to $9.9 million from $4.1 million as personnel and stock-compensation costs grew alongside the company’s leadership team and operating infrastructure. Steve Hoerter succeeded Kent Hawryluk as chief executive and became chairman and CEO after the June clinical update, while interim finance chief John Smither was appointed chief financial officer.
MBX also reported preliminary blinded efficacy data for obesity candidate MBX 4291. Eight participants, including two who received placebo, recorded mean weight loss of 7% after eight weeks, with results ranging from 0% to 16%. One participant experienced a mild diarrhea event, while there were no nausea, vomiting or serious adverse events through eight weeks.
The company expects the first 12-week multiple-ascending-dose results for MBX 4291 in the fourth quarter. The tested titration regimen comprised four weekly 30-milligram doses followed by monthly doses of 120 milligrams and 180 milligrams.
MBX broadened its obesity pipeline by nominating MBX 6180, a GLP-1/GIP/glucagon triple-agonist prodrug, and starting studies needed to support an investigational-new-drug application. The company plans to present preclinical data in the fourth quarter. It also advanced IND-enabling work on MBX 5765, a once-monthly amycretin prodrug nominated in May that combines GLP-1, GIP and glucagon activity with dual amylin and calcitonin receptor activity.
Cash, cash equivalents and marketable securities stood at $418.6 million on June 30. MBX expects that balance to support operations into 2029 as spending shifts toward later-stage canvuparatide development and a wider obesity portfolio.