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Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Grants SiSaf\u2019s Innovative siRNA Therapy SIS-101-ADO Orphan Drug Designation and Rare Pediatric Disease Designation for the Treatment of Autosomal Dominant Osteopetrosis","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"IND Enabling","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"SiSaf"},{"orgOrder":0,"company":"Arrowhead Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Arrowhead Pharmaceuticals Files for Regulatory Clearance to Initiate a Phase 1\/2 Study of ARO-DUX4 for Facioscapulohumeral Muscular Dystrophy","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Arrowhead Pharmaceuticals"}]
Find FDA Investigational New Drug (IND) Submissions for Musculoskeletal
ARO-DUX4 is an investigational RNAi therapeutic designed to reduce expression of the gene that encodes the human double homeobox 4 (DUX4) protein as a potential treatment for FSHD.
SIS-101-ADO is an siRNA that suppresses the expression of CLCN7, a mutant gene expressed by osteoclasts and other cell types responsible for causing ADO2, the RNA therapy restores bone mass and quality to nearly normal levels.
The investment will support development of Epic’s lead program EPI-321, a novel therapeutic that is designed to correct the epigenetic alterations in the D4Z4 region of chromosome 4.
SIG002 consists purified secretome free of tissue fragments and cells. SIG002 has demonstrated immunoregulatory properties relevant to address the degenerative inflammatory processes involved in osteoarthritis disease etiology.
SIS-101-ADO combines an siRNA that suppress expression of CLCN7, with SiSaf’s Bio-Courier® next generation silicon stabilized hybrid lipid nanoparticles technology of other RNA delivery technologies by merging LNP technology with inorganic bioabsorbable silicon.
FSD201 is a proprietary formulation of ultra-micronized palmitoylethanolamide (PEA). FSD Pharma’s successfully completed Phase 1 clinical trial showed FSD201 to be safe and well tolerated.
Epoladerm™ (diclofenac epolamine), an investigational analgesic supplied in a pre-filled device for administration as a topical spray film to manage chronic pain associated with osteoarthritis of the knee.
Epoladerm (diclofenac epolamine), an investigational analgesic supplied in a pre-filled device for administration as a topical spray film to manage chronic pain associated with osteoarthritis of the knee.
Data show mdHACM mitigates effects of inflammatory-induced degeneration in chondrocytes, the Primary Cell Type in Cartilage. These results further support mdHACM as an investigational new drug candidate for the treatment of OA and highlight potential disease activities.
Lead Product(s):
Micronized Dehydrated Human Amnion Chorion Membrane
Virpax intends to use the net proceeds from the offering to fund research and development of the Epoladerm, Probudur, Envelta and AnQlar indications and other development programs in clinical trial.
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