By Louise Gagnon
ORLANDO, Fla -- September 25, 2019 -- Setrusumab, a fully human recombinant monoclonal antibody, shows promise for the treatment of osteogenesis imperfecta (OI), according to a study presented here at the 2019 Annual Meeting of the American Society for Bone and Mineral Research (ASBMR).
“There is a clinical unmet need,” said Bettina Willie, PhD, McGill University, and Shriners’ Hospital, Montreal, Quebec. “[OI] is a rare disease, for which there is no currently approved drug. It is managed with things like bisphosphonates, vitamins, and physiotherapy. [Setrusumab] is being studied as a treatment for OI.”
In the dose-finding trial, 112 patients received 3 different doses (low, medium, and high) of monthly intravenous infusions of setrusumab in a blinded fashion. A total of 21 patients were in the open-label arm and received the high dose.
A total of 102 patients have been treated for >6 months, with 33 patients treated for 12 months. Nine patients have ceased the therapy.
The researchers calculated bone mass with high-resolution peripheral quantitative computed tomography.
The open-label group demonstrated a mean increase from baseline in total trabecular volume bone mineral density of the radius of 1.4% to month 3 and 3.2% to month 6. The mean areal bone mineral density rose by 3.5% from baseline to month 6.
No serious adverse events were reported. Headache was the most commonly reported adverse event.
“The results are very encouraging,” concluded Dr. Willie. “We look forward to seeing the full data at 12 months. We expect a robust effect.”
Beyond 12 months of treatment, patients will be off treatment for 12 months and have bone density measured at the end of 12 months of follow-up.
“We will see what will happen to bone density in the follow-up period,” said Dr. Willie.
Funding for the study was provided by Mereo BioPharma.
[Setrusumab for the Treatment of Adults With Osteogenesis Imperfecta: 6-Month Data From the Open-Label Treatment Arm of the Phase 2b ASTEROID Study. Abstract 1040]
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