Paradigm Biopharmaceuticals

Stockhead 's Tim Boreham covers Paradigm in his weekly dive, Biocurious. Read more: https://lnkd.in/eHZjJ9BH

We're pleased to share today's update as we approach a critical phase in our journey: - FDA Submission: Paradigm will submit the revised Phase 3 (PARA_OA_012) protocol to the FDA by the end of October, reflecting extensive feedback and collaboration. - Enhanced Trial Design: Improvements focus on patient convenience and efficiency and reducing costs. - CRO Selection: We've shortlisted four global CROs for our Phase 3 trial, with the final selection coming soon. - Next Steps: Pending FDA review, enrolment is set to begin in Q1 2025, starting with up to 10 sites in Australia. Thank you to our investors for your continued support as we work toward delivering an impactful therapy for those suffering with OA. Stay tuned for more updates. #ParadigmBiopharma #iPPS #ClinicalTrials #FDA #Osteoarthritis #Biotech #Phase3

This Saturday, we acknowledge World Arthritis Day, a day to recognise and support the millions of people worldwide who live with the challenges of arthritis. It's a moment for the community to feel seen, heard, and supported. Reminding us all of the importance of awareness, empathy, and action.   At Paradigm, our ongoing work with Pentosan Polysulfate Sodium is fueled by our unwavering dedication to those affected by osteoarthritis (OA).   For us, progressing this treatment isn't just about pain management. It’s about restoring the freedom of movement, independence, and overall quality of life for people who’ve had to adjust their lives around this debilitating condition.   Every step forward brings us closer to a future where those with OA can live with less pain and more mobility.   On World Arthritis Day, we stand with the OA community and reaffirm our commitment to advancing life-changing therapies that offer a brighter tomorrow. Read more at the link below.   #WorldArthritisDay #PAR $PAR #Osteoarthritis # #PentosanPolysulfate #ParadigmBiopharma #ArthritisAwareness #PPS

Stockhead has just released a new 'Break It Down' episode covering Paradigm’s latest update on recent FDA feedback. Watch below:

We are pleased to announce a positive response from the U.S. FDA.   The FDA's feedback on our phase 2 clinical data confirms the safety and tolerability of our dosing regimen (2mg/kg iPPS administered twice weekly). It offers a clear pathway to move forward with the pivotal phase 3 trial.    This is a significant milestone for Paradigm.   Paul Rennie, Managing Director, stated: ‘I understand that many investors are eager to know the dosage that will be used in the pivotal phase 3 clinical trial. I am pleased to announce that the FDA has indicated our clinical data supports the safety and tolerability of the twice-weekly administration of 2 mg/kg, the same dosing regimen Paradigm used in its phase 2 clinical studies (PARA_005 and PARA_OA_008). We would like to extend our gratitude to the US FDA for their valuable guidance on the phase 3 protocol’.   You can read more at the link below.

Pitt Street Research initiates coverage on Paradigm Biopharmaceuticals. Paradigm’s flagship asset is Zilosul, an injectable form of pentosan polysulfate sodium (PPS). Zilosul is a non-opioid, anti-inflammatory drug that Paradigm is seeking to use to treat multiple indications, most particularly osteoarthritis. Zilosul is in Phase 3 for osteoarthritis having passed multiple Phase 2 trials. The drug has been Fast Tracked by the FDA and has the opportunity for expedited approval in Australia through TGA Provisional Approval. Even though there are plenty of drugs available to osteoarthritis patents, we believe Paradigm has an enormous opportunity. The vast majority of treatment options available for osteoarthritis require frequent administration and/or suffer reduced effectiveness over time. Many of them can be opioid-based and cause side-effects not just harmful to individual patients, but to society as a whole.  This is not the case with Zilosul, and we could see it on the market within less than 3 years from today. Even prior to regulatory approval, we see upside in the company that could result from potential licensing deals for Zilosul as well as clinical progress against other indications the company is targeting, particularly Mucopolysaccharidosis (MPS). We value Paradigm Biopharmaceuticals at A$0.76 per share in our base case scenario and A$1.06 per share in our optimistic (or bull) case scenario. We believe Paradigm can re-rate if the current clinical trial is a success and the company can subsequently commercialise the drug. Other catalysts include potential licensing deals which could be sealed even prior to the release of clinical trial results. Please note that this is report is General Advice only and one that we have been commissioned to prepare. Please see p.24 for the key risks associated with our investment thesis and the final page for the full General Advice Warning, disclosure and disclaimers. https://lnkd.in/gdEGt9H6

Paradigm's 2024 Annual Report has been released. Managing Director Paul Rennie shares: "Paradigm Biopharmaceuticals made significant advancements in FY 2024 with clinical programs in knee osteoarthritis (OA) and mucopolysaccharidosis (MPS). The Company reported outstanding phase 2 data de-risking iPPS for musculoskeletal disorders and engaged in major regulatory discussions with the FDA to advance the 2mg/kg dose for the phase 3 OA program." Key Highlights: - iPPS shows 12-month efficacy - Structural improvements seen at six months - PARA_OA_002 Stage 1 completed Read the full report: https://lnkd.in/gCmVzGp8 #ParadigmBiopharmaceuticals #ASXPAR #AnnualReport #ClinicalTrials #Healthcare #Biotech #AUSBiotech

🌟 Exciting News! Paradigm Biopharma has been featured in the Stockhead 2024 Biotech Investor Guide, highlighting our progress alongside other key players in the Australian healthcare sector. Founder and MD, Paul Rennie, delves into the promising opportunities as we advance through the final phase of iPPS development for knee OA. Our consistent and significant results from two phase 2 studies demonstrate iPPS's potential to revolutionise treatment for knee OA patients by not just addressing symptoms but enhancing overall joint structure. A big thank you to tim boreham and Stockhead for the recognition! To explore more about Paradigm and our future prospects, check out the full article on Stockhead here:  https://lnkd.in/gppgdwNK #Biotech #HealthcareSector #Innovation #KneeOA #ParadigmBiopharma #StockheadFeature 🚀🩺

Thank you to the team at Sharewise for hosting Paradigm Managing Director, Paul Rennie, today for an overview of the Company's OA clinical results and progress. For those that missed it you can watch via the link below. #ASX #Biotech #iPPS #Osteoarthritis #Pain #KneeOA

Catch up on yesterday's interview with Paradigm MD, Paul Rennie. Thank you to the team at Grafa for featuring Paradigm on their fantastic new platform.