Paradigm submits key documents to US FDA to advance its pivotal Phase 3 trial of iPPS\/Zilosul
\nBiotech also submits a draft of protocol for the Phase 3 pivotal clinical trial to FDA for review and comment
\nPending FDA clearance, PAR aims to kick off enrolment into the Phase 3 clinical trial in the H2 CY24. <\/p>\n
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Special Report: Paradigm Biopharmaceuticals has submitted key documents to the US Food and Drug Administration (FDA) for review, aiming to advance its pivotal Phase 3 clinical trial of lead drug injectable pentosan polysulfate sodium (iPPS\/Zilosul)<\/strong> to treat osteoarthritis (OA). <\/strong><\/p>\n Often referred to as degenerative joint disease or \u2018wear and tear\u2019 arthritis, osteoarthritis (OA) stands out as the most common form of this condition.<\/p>\n However, PAR aims to minimize its impact by improving the functional mobility and preserving the joint structure and reducing pain of affected individuals.<\/p>\n The company is developing injectable pentosan polysulfate sodium (iPPS\/Zilosul) for the treatment of OA and Mucopolysaccharidosis, where inflammation significantly contributes to the disease process.<\/p>\n A Phase 2 trial demonstrated<\/a> one course of subcutaneous iPPS can provide 12-month pain relief and improved function in knee OA sufferers. The same clinical trial also demonstrated improvement in cartilage volume and thickness at six months following treatment compared to placebo.<\/p>\n Furthermore, PAR announced in February<\/a> its Phase 2 clinical trial, PARA_MPSVI_001, had successfully met its\u00a0primary endpoint.<\/p>\n The trial was designed to evaluate the use of iPPS\u00a0compared to placebo in 13 participants with\u00a0Mucopolysarcharidosis Type VI (MPS VI).<\/p>\n \u00a0<\/p>\n Phase I trials are concerned primarily with establishing a new drug\u2019s safety and dose range, while Phase II studies determine the effectiveness of an experimental drug on a particular disease or condition.<\/p>\n The most advanced trials are Phase III, in which massive testing provides a huge amount of data on a drug\u2019s safety and efficacy.\u00a0Once a Phase III study is completed, a pharmaceutical company can request FDA approval to market the drug.<\/p>\n Paradigm Biopharmaceuticals (ASX:PAR)<\/strong><\/a> says the submission of docs to the US FDA to move to Phase III includes a response to the Type D meeting held in January encompassing results from five nonclinical studies, data from the successful phase 2 clinical trial, PARA_OA_008, and clinical data from 600 participants in stage 1 of PARA_OA_002.<\/p>\n PAR says the additional data was collected post the Investigational New Drug (IND) submission to the FDA in March 2021, with most not previously submitted nor reviewed by the agency.<\/p>\n The company says the data provides comprehensive justification for the clinical development of iPPS with a dosing regimen of 2mg\/kg twice weekly for six weeks as initial therapy.<\/p>\n Additionally, PAR has submitted a draft of the protocol for the Phase 3 pivotal clinical trial (PARA_OA_012) to the FDA review and comment.<\/p>\n The response package has been submitted through a request for review pathway as directed by the regulatory agency, with anticipated feedback within three months.<\/p>\n Key aspects addressed in the Type D FDA response submission include:<\/p>\n Additional nonclinical studies completed to GLP standards to address previously noted adrenal findings \u00a0<\/strong><\/p>\n Pending FDA clearance, PAR aims to kick off enrolment into the Phase 3 clinical trial in the H2 CY24.<\/p>\n Preparation activities for clinical trial sites in Australia and the US are scheduled to start in Q2 CY24 to expedite the progress of the phase 3 trial.<\/p>\n PAR will also finalise a Therapeutic Goods Administration (TGA) provisional approval determination application for submission.<\/p>\n PAR says application will include information from a manuscript detailing outcomes from\u00a0 its PARA_OA_008\u00a0 Phase 2 clinical\u00a0 trial\u00a0 and a manuscript providing comparison of iPPS clinical\u00a0 data with other available treatments for OA.<\/p>\n Should the determination application decision be positive, the biotech will prepare a full dossier submission for TGA provisional approval marketing authorisation.<\/p>\n The company says provisional approval presents notable advantages for both patients and manufacturers. Patients can access potentially life-saving treatments for critical conditions sooner, especially when satisfactory alternatives are lacking.<\/p>\n For manufacturers, it offers a chance to introduce innovative therapies to market more swiftly, while collecting additional data to bolster full approval.<\/p>\n PAR says TGA provisional marketing approval for iPPS in Australia would accelerate the path to revenues.<\/p>\n Completed manuscripts are currently being readied for submission to various journals for peer-review and publication.<\/p>\n \u00a0<\/p>\n PAR managing director Paul Rennie says delivering a significant amount of new data to the FDA for review to progress to the next stage of the Phase 3 OA trial is significant.<\/p>\n \u201cSince Paradigm\u2019s IND submission in March 2021, we have treated close to 700 participants under a clinical trial setting with various iPPS doses, which provides strong justification that 2mg\/kg twice weekly is the lowest effective dose with which to move forward,\u201d he says.<\/p>\n \u201cWe look forward to receiving the FDA\u2019s feedback and remain ready to answer any further questions.\u201d<\/p>\n \u00a0<\/p>\n This article was developed in collaboration with [Client Name], a Stockhead advertiser at the time of publishing. <\/em>\u00a0<\/em><\/p>\n This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.<\/em><\/p>\n <\/span><\/p>\n The post Paradigm makes key submission to US FDA to advance osteoarthritis Phase 3 trial<\/a> appeared first on Stockhead<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"Key documents submitted to US FDA for pivotal Phase 3 trial<\/strong>\u00a0<\/strong><\/h2>\n
\nDraft clinical trial protocol
\nRevised safety monitoring and mitigation plan<\/p>\nNext steps for PAR<\/strong><\/h2>\n
Treated close to 700 patients<\/strong><\/h2>\n