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Find Clinical Drug Development Pipelines & Deals | PipelineProspector
The agreement aims for the commercialization of an investigational osteoarthritis (OA) therapy, VOLT01 (zoledronic acid), a patented novel combination drug, in the Middle East and Africa (MEA) region, excluding South Africa.
Approximately 50% of patients with Dupuytren’s disease treated with Adalimumab also have frozen shoulder and Professor Nanchahal has previously shown that that TNF, a pro-inflammatory protein, is a key driver of the fibrosis in early-stage Dupuytren’s disease.
Phase 2b clinical trial for Dupuytren’s disease using Humira (adalimumab), met both primary and secondary endpoints by significantly diminishing the hardness and size of the Dupuytren’s nodules.
The top line data from the phase 2b clinical trial of Humira (Adalimumab) for patients with early-stage disease, met the primary end point of nodule hardness and the secondary end point of nodule size on ultrasound scan with statistically significant differences.
Under the MOU with Celltrion Healthcare, supply of anti-TNF biosimilar drug used in the ongoing development for new indications including the first antibody biosimilar, Remsima®, infliximab for major autoimmune disorders such as rheumatoid arthritis and ulcerative colitis.
The primary efficacy evaluation of two potential therapeutic doses of XT-150 (150 and 450 μg) will be assessed at six months, followed by an additional six-month safety follow-up with the opportunity for a second injection. Topline results are expected in 4th quarter of 2021.
XT-150 is currently in a Phase II/III trial for osteoarthritis, and Nguyen expects to read out topline Phase IIb data in Q4. XT-150, is a locally injectable plasmid DNA gene therapy expressing Interleukin 10 (IL-10).
This phase 2/3 multi-center, randomized, double-blind trial investigated the effect of a new 3.06% diclofenac sodium gel formulation (AMZ001) for the relief of knee OA pain, in 444 patients exposed to either AMZ001 once daily (QD), AMZ001 twice daily (BID) or placebo.
Two studies are the pivotal JTA-004 Ph III clinical study targeting osteoarthritic knee pain and Ph IIb study of its allogeneic cell therapy product, ALLOB, in difficult tibial fractures.
Lead Product(s):
Plasma proteins,Hyaluronic Acid,Fast-acting analgesic