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Osteoporosis","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Peptide","productStatus":"Approved","date":"October 2022","url1":"","url2":"","graph1":"Peptide","graph2":"EnteraBio Ltd"},{"orgOrder":0,"company":"Fulcrum Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Fulcrum Therapeutics to Present New Data from the Open Label Extension of Phase 2 ReDUX4 Study at the World Muscle Society (WMS) Congress in Halifax, Canada","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Fulcrum Therapeutics"},{"orgOrder":0,"company":"Assia Chemical Industries Ltd","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not 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Find Musculoskeletal Drugs in Phase III Clinical Development
Fulcrum Therapeutics intends to use the net proceeds for the development of FTX-1821 (losmapimod), a small molecule, for the treatment of facioscapulohumeral muscular dystrophy (FSHD).
TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism.
Cingal (sodium hyaluronate) combination product of cross-linked hyaluronic acid (HA) proven to provide long lasting pain relief through 6 months plus TH steroid to provide fast, short-term pain relief.
AUSTEDO (deutetrabenazine) is the first and only vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration for the treatment of tardive dyskinesia (TD) in adults and for the treatment of chorea associated with Huntington’s disease.
Results reported from the ReDUX4 trial demonstrated slowed disease progression and improved function, including positive impacts on upper extremity strength, supporting Losmapimod’s (FTX-1821) potential to be a transformative therapy for the treatment of FSHD.
EB613 is the first oral, daily tablet formulation of synthetic hPTH (1-34), (teriparatide), consisting of the exact same 34 amino acid sequence as daily subcutaneous teriparatide injection, Forteo® which has been the leading anabolic treatment of osteoporosis.
Pentosan Polysulfate Sodium (under the name Zilosul®) is used to treat osteoarthritis. iPPS impacted multiple biomarkers measured in the synovial fluid. Reductions in nerve growth factor (NGF) indicate iPPS mechanisms related to pain reduction.
Denosumab (GP2411) is a human monoclonal antibody designed to bind to the RANKL protein, an activator of osteoclasts. By binding to and inhibiting RANKL, denosumab decreases the production and activity of osteoclasts, resulting in a reduction of bone loss.
The biosimilars planned under this agreement include biosimilar of Prolia® (denosumab, AVT03), Xgeva® (denosumab), Simponi® (golimumab), and Eylea® (aflibercept) as well as two undisclosed proposed biosimilars for immunology and oncology.
AVT03 is human mAB and biosimilar candidate to Prolia® and Xgeva® (denosumab), targets and binds with high affinity and specificity to RANK ligand membrane protein, preventing RANK ligand/RANK interaction from occurring, resulting in reduced osteoclast numbers and function.
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