A Randomised, Double-blind, Parallel, Multicentre, Multinational Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of MB09 (Proposed Denosumab Biosimilar) Versus Prolia® (EU-sourced) in Postmenopausal Women With Osteoporosis (SIMBA Study)

This is a randomized, double-blind, parallel, multicenter, multinational study to compare the efficacy, pharmacokinetics, pharmacodynamics, safety and immunogenicity of MB09 versus Prolia® in postmenopausal women with osteoporosis

Start Date31 Mar 2022

Sponsor / Collaborator

mAbxience Research SL

NCT05299073

/ CompletedPhase 1

A Randomised, Double-blind, Three-arm, Single-dose, Parallel Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity Profile of MB09 (Denosumab Biosimilar) and EU/US-sourced Xgeva® in Healthy Male Volunteers

Randomized, double blind, parallel group, single dose, 3 arm study to investigate and compare the PK, PD, safety and immunogenicity profile of MB09 with EU/US-Xgeva® in healthy male subjects.
During the course of the study, the similarity in pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms. Pharmacodynamics, safety, tolerability, and immunologic response to the administered drugs will also be evaluated throughout.

Start Date01 Mar 2022

Sponsor / Collaborator

mAbxience Research SL

100 Clinical Results associated with MB-09

100 Translational Medicine associated with MB-09

100 Patents (Medical) associated with MB-09

Literatures (Medical) associated with MB-09

01 Sep 2024·Clinical and Translational Science

MB09, a denosumab biosimilar candidate: Biosimilarity demonstration in a phase I study in healthy subjects

Article

Author: Carapuça, Elisabete ; Florez‐Igual, Amalia ; Queiruga‐Parada, Javier ; Tomaszewska‐Kiecana, Monika

AbstractThis was a Phase I, randomized, double‐blinded, three‐arm, single‐dose, parallel study aimed to demonstrate pharmacokinetic (PK) similarity between MB09 (a denosumab biosimilar candidate) and reference denosumab (XGEVA® from European Union [EU‐reference] and United States [US‐reference]) in a healthy male population. The primary PK endpoints included: Area under the serum concentration versus time curve from time 0 to the last quantifiable concentration timepoint (AUC0–last); and maximum observed serum concentration (Cmax). Secondary endpoints included: AUC from time 0 extrapolated to infinity (AUC0–∞), time to reach maximum observed concentration, clearance, terminal phase half‐life, pharmacodynamic, safety, and immunogenicity assessments. A total of 255 subjects were randomized (1:1:1) to receive a subcutaneous 35 mg dose of MB09 or reference denosumab. Cmax was reached after denosumab administration, followed by a decline in the concentration with similar terminal phase half‐live across treatment arms. Systemic exposure of MB09 (AUC0–last and Cmax) was equivalent to the reference denosumab, as the 90% confidence intervals around the geometric least square mean ratios laid within the predefined acceptance limits (80.00%, 125.00%) across all comparisons. Pharmacodynamic parameters, based on the percent of change from baseline in serum C‐terminal telopeptide of Type 1 collagen levels, were similar across the three arms. The treatments were considered safe and generally well tolerated, with 92 treatment‐emergent adverse events reported (most Grade 2 and 3) and similarly distributed. Immunogenicity was low and similarly distributed. These results provide strong evidence that supports the biosimilarity between MB09 and denosumab reference products.

100 Deals associated with MB-09

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Indication	Highest Phase	Country/Location	Organization	Date
Osteoporosis, Postmenopausal	Phase 3	PL	mAbxience Research SL	31 Mar 2022
Osteoporosis, Postmenopausal	Phase 3	LV	mAbxience Research SL	31 Mar 2022
Osteoporosis, Postmenopausal	Phase 3	HU	mAbxience Research SL	31 Mar 2022
Osteoporosis, Postmenopausal	Phase 3	BG	mAbxience Research SL	31 Mar 2022
Osteoporosis, Postmenopausal	Phase 3	EE	mAbxience Research SL	31 Mar 2022
Osteoporosis, Postmenopausal	Phase 3	MX	mAbxience Research SL	31 Mar 2022
Osteoporosis, Postmenopausal	Phase 3	RS	mAbxience Research SL	31 Mar 2022
Osteoporosis, Postmenopausal	Phase 3	GE	mAbxience Research SL	31 Mar 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05299073 (CTgov)	Phase 1	-	257	MB09 (MB09 (Denosumab Biosimilar))	(japklsiqxk) = sfgrhwesva spirehqrbv (fwlicxwglv, uyjxxvjaqz - ipxwdxblcb) View more	-	03 Jan 2025
				US-sourced Xgeva (US-sourced Xgeva)	(japklsiqxk) = qjtuozeoul spirehqrbv (fwlicxwglv, gfnekcsnbs - yprrhtofvi) View more

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