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Asset Brief

iPPS

PAR·Paradigm Biopharmaceuticals Limited·Knee osteoarthritis (OA) pain·Phase 3·NCT06917404·Primary completion: 1 July 2027

Plain-language Brief

The trial in plain terms

The disease: Osteoarthritis (OA) of the knee is a degenerative joint condition characterised by the breakdown of cartilage and associated pain and reduced mobility. It is one of the most common musculoskeletal conditions globally. There are currently no disease-modifying therapies approved for knee OA; available treatments focus on managing symptoms. Many patients continue to experience inadequate pain relief on existing options.
What the asset is trying to do: iPPS is pentosan polysulfate sodium (PPS), a semi-synthetic polysaccharide administered by subcutaneous (under-the-skin) injection. PPS belongs to the polysaccharide therapeutic class. The proposed mechanism of action distinguishes it from oral analgesics and intra-articular (joint injection) approaches such as corticosteroids or hyaluronic acid, though no mechanism-of-action data are included in the input provided for this brief.
What the trial is measuring, and why it matters: The pivotal Phase 3 trial (NCT06917404) compares subcutaneous PPS to placebo in participants with knee OA (per ClinicalTrials.gov NCT06917404). The primary completion date is July 2027 (per ClinicalTrials.gov NCT06917404). Specific primary and secondary endpoints for NCT06917404 are not detailed in the data provided for this brief and are marked below accordingly. Pain and functional endpoints are standard measures in knee OA trials and are typically assessed using validated patient-reported outcome scales.
Efficacy benchmarks in this setting: In knee OA, approved and widely used analgesic and symptomatic therapies provide points of reference for pain reduction. Non-steroidal anti-inflammatory drugs (NSAIDs) such as celecoxib have demonstrated statistically significant reductions on standard OA pain scales versus placebo in randomised controlled trials (per Hochberg et al, New England Journal of Medicine 2016, and product prescribing information); specific effect-size figures for this brief require direct citation from those publications and are marked pending source verification. Intra-articular corticosteroids have shown short-term pain relief in randomised trials, with effect sizes (per Jüni et al, JAMA 2015). Early-stage or previous PPS trial figures (including any results from NCT04809376 or NCT04814719) are not statistically comparable to pivotal trial outcomes and should not be interpreted as predictive of Phase 3 results.
Commercial context: No disease-modifying therapy for knee OA is currently approved by the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA). PPS (as Elmiron) is approved in the United States for interstitial cystitis, a separate indication, but is not approved for OA in any major market (per FDA prescribing information for Elmiron). iPPS appears to be Paradigm Biopharmaceuticals' lead pipeline asset based on the company's disclosed focus on this programme. No licensing deal terms or manufacturing partnership disclosures are included in the data provided for this brief.

Sources for this brief (8)

NCT06917404 - A Study to Investigate the Treatment Effect of Subcutaneous Injections of Pentosan Polysulfate Sodium Compared With Placebo · ClinicalTrials.gov / U.S. National Library of Medicine · accessed 15 June 2026
NCT04809376 - Treatment Effects of Subcutaneous Injections of Pentosan Polysulfate Sodium vs Placebo in Participants With Knee OA Pain · ClinicalTrials.gov / U.S. National Library of Medicine · accessed 15 June 2026
NCT04814719 - Treatment and Duration Effect of Pentosan Polysulfate Sodium (PPS) in Participants With Knee Osteoarthritis Pain · ClinicalTrials.gov / U.S. National Library of Medicine · accessed 15 June 2026
Elmiron (pentosan polysulfate sodium) US Prescribing Information · U.S. Food and Drug Administration · accessed 15 June 2026
PAR Completes Enrolment in Pivotal Phase 3 (ASX announcement) · Paradigm Biopharmaceuticals Limited / ASX · accessed 15 June 2026
DSMB 20% Review Supports Phase 3, Moldova Activated (ASX announcement) · Paradigm Biopharmaceuticals Limited / ASX

Trial Design

Design summary

Phase: Phase 3
Design type: Randomised, placebo-controlled, double-blind (inferred from intervention arms listing Pentosan Polysulfate Sodium twice weekly and Placebo). Multi-centre.
Primary endpoint: [ TODO: fill in ]
Key secondary endpoints: [ TODO: fill in ]
Enrolment target: 466 patients (per ClinicalTrials.gov NCT06917404)
Current enrolment status: Enrolment complete (per PAR ASX announcement, 14 June 2026)
Sites: Multi-country; Moldova site activated (per PAR ASX announcement, 29 April 2026). Full site list: [ TODO: fill in ]
Expected readout window: Primary completion is listed as 2027-07-01 (per ClinicalTrials.gov NCT06917404). Enrolment was completed in June 2026 (per PAR ASX announcement, 14 June 2026). Top-line data timing beyond the primary completion date is not specified in the data provided.

Asset Track Record

Did PAR deliver against its own guidance?

Past catalysts on this ticker, reconciled against the announcement parse pipeline. Hover any row for the parsed outcome detail.

21 July 2026otherParadigm Receives $5.75m R&D Tax Incentive Refundhitsrc
13 July 2026financingDrawdown of Tranche 4 under the Convertible Note Facilityhitsrc ASX ↗
1 June 2026financingResults of Share Purchase Planhitsrc ASX ↗
1 June 2026financingUpdate - Proposed issue of securities - PARhitsrc ASX ↗
29 Apr 2026data readoutDSMB 20% Review Supports Phase 3, Moldova Activatedhit · positivesrc ASX ↗
30 Mar 2026data readoutParadigm Achieves 50% Patient Dosing in Phase 3hitsrc
19 Mar 2026data readoutHong Kong Site Activated for Phase 3 OA Studyhitsrc

Class Catalyst Calendar

What's landed, what's next for iPPS and peers

iPPS's own upcoming catalysts alongside class-defining historical readouts and upcoming primary completion dates in the same mechanism classes. Each event moves the broader thesis for iPPS. Showing past 6 months and next 12 months · 10 later hidden.

ConferenceAACR Annual Meeting 2026· ChicagoApr 2026
ConferenceASCO Annual Meeting 2026· ChicagoMay 2026
Today
Optimal Articular Solutions With Intraosseous and Synovial Platelet-Rich Plasma
Universidade do Porto

Trial design comparison

How iPPS reads against active peer trials

Same axes, same units. Discontinued and historical pivotal trials excluded; see Competitor Landscape below for the full set.

Trial	Sponsor	Class	Phase / Line	Design	Primary endpoint	Dosing	Key eligibility	n
iPPS	Paradigm Biopharmaceuticals Limited	Polysaccharide therapeutic	Phase 3[ TODO: fill in ]	Randomised, placebo-controlled, double-blind (inferred from intervention arms listing Pentosan Polysulfate Sodium twice weekly and Placebo). Multi-centre.	[ TODO: fill in ]	Subcutaneous injection twice weekly	466 patients (per ClinicalTrials.gov NCT06917404)	466
Efficacy and Safety of Tongren-Dahuoluo Bolus in Patients with Knee Osteoarthritis

Competitor Landscape

Competing programmes by mechanism and phase

Read-across commentary attached per trial. Phase ordering preserved within each group.

OtherASX peers ›

40 activeexpand ›

GH
Efficacy and Safety of Tongren-Dahuoluo Bolus in Patients with Knee Osteoarthritis
Phase 4
Guang'anmen Hospital of China Academy of Chinese Medical Sciences·Not yet recruiting·Primary completion 30 June 2025·NCT06674759
LH
Platelet Rich Plasma Versus Corticosteroids in Hip Osteoarthritis Pain

Curated Commentary

Third-party coverage(none curated yet)

expand ›

External analyst notes, journalism, and industry commentary cited with attribution.

No third-party coverage curated for iPPS yet. Broker coverage of Paradigm Biopharmaceuticals Limited is thin; named analyst notes will appear here as they become available. For now, see the company's ASX announcements and the linked sponsor / class sources elsewhere on this page.

Asset Track Record

Did PAR deliver against its own guidance?

Past catalysts on this ticker, reconciled against the announcement parse pipeline. Hover any row for the parsed outcome detail.

21 July 2026otherParadigm Receives $5.75m R&D Tax Incentive Refundhitsrc
13 July 2026financingDrawdown of Tranche 4 under the Convertible Note Facilityhitsrc ASX ↗
1 June 2026financingResults of Share Purchase Planhitsrc ASX ↗
1 June 2026financingUpdate - Proposed issue of securities - PARhitsrc ASX ↗
29 Apr 2026data readoutDSMB 20% Review Supports Phase 3, Moldova Activatedhit · positivesrc ASX ↗
30 Mar 2026data readoutParadigm Achieves 50% Patient Dosing in Phase 3hitsrc
19 Mar 2026data readoutHong Kong Site Activated for Phase 3 OA Studyhitsrc

Class Catalyst Calendar

What's landed, what's next for iPPS and peers

ConferenceAACR Annual Meeting 2026· ChicagoApr 2026
ConferenceASCO Annual Meeting 2026· ChicagoMay 2026
Today
Optimal Articular Solutions With Intraosseous and Synovial Platelet-Rich Plasma
Universidade do Porto

Trial design comparison

How iPPS reads against active peer trials

Same axes, same units. Discontinued and historical pivotal trials excluded; see Competitor Landscape below for the full set.

Trial	Sponsor	Class	Phase / Line	Design	Primary endpoint	Dosing	Key eligibility	n
iPPS	Paradigm Biopharmaceuticals Limited	Polysaccharide therapeutic	Phase 3[ TODO: fill in ]	Randomised, placebo-controlled, double-blind (inferred from intervention arms listing Pentosan Polysulfate Sodium twice weekly and Placebo). Multi-centre.	[ TODO: fill in ]	Subcutaneous injection twice weekly	466 patients (per ClinicalTrials.gov NCT06917404)	466
Efficacy and Safety of Tongren-Dahuoluo Bolus in Patients with Knee Osteoarthritis

Competitor Landscape

Competing programmes by mechanism and phase

Read-across commentary attached per trial. Phase ordering preserved within each group.

OtherASX peers ›

40 activeexpand ›

GH
Efficacy and Safety of Tongren-Dahuoluo Bolus in Patients with Knee Osteoarthritis
Phase 4
Guang'anmen Hospital of China Academy of Chinese Medical Sciences·Not yet recruiting·Primary completion 30 June 2025·NCT06674759
LH
Platelet Rich Plasma Versus Corticosteroids in Hip Osteoarthritis Pain

iPPSn = 466

Paradigm Biopharmaceuticals Limited·Polysaccharide therapeutic·Phase 3·[ TODO: fill in ]

Design: Randomised, placebo-controlled, double-blind (inferred from intervention arms listing Pentosan Polysulfate Sodium twice weekly and Placebo). Multi-centre.
Primary endpoint: [ TODO: fill in ]
Dosing: Subcutaneous injection twice weekly
Eligibility: 466 patients (per ClinicalTrials.gov NCT06917404)

Efficacy and Safety of Tongren-Dahuoluo Bolus in Patients with Knee Osteoarthritisn = —

Guang'anmen Hospital of China Academy of Chinese Medical Sciences·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Platelet Rich Plasma Versus Corticosteroids in Hip Osteoarthritis Painn = —

LifeBridge Health·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Optimal Articular Solutions With Intraosseous and Synovial Platelet-Rich Plasman = —

Universidade do Porto·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Corticosteroid Meniscectomy Randomized Trialn = —

The Cleveland Clinic·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

PRP for Glenohumeral Osteoarthritisn = —

Hospital for Special Surgery, New York·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Pain Perception During Intra-Articular Knee Joint Injection: What is the Effect of Needle Gauge and the Use of Ethyl Chloride?n = —

University of California, Davis·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Comparison of Suzetrigine and Oxycodone for Postoperative Pain After Primary Total Knee Arthroplastyn = —

University of Louisville·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Intraarticular Steroids, Saline and Occupational Therapy in People With CMC1 Osteoarthritisn = —

Diakonhjemmet Hospital·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Subcutaneous Tirzepatide Once-weekly in Patients With Obesity and Knee Osteoarthritis (STOP KNEE-OA)n = —

University of Melbourne·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Systemic Oral Glucocorticoids for the Treatment of Acute Osteoarthritis Pain in the Emergency Departmentn = —

WellSpan Health·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Phase 4 Study of Laybon Tab. in Knee Osteoarthritisn = —

Mather's Pharm. Co., Ltd.·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Post-Operative Pain Relief: Zynrelef or Periarticular Injections in RATKAn = —

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Brain-Based and Clinical Phenotyping of Pain Pharmacotherapy in Knee Osteoarthritisn = —

Northwestern University·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Study to Determine the Efficacy and Safety of TG-C in Subjects With Kellgren/Lawrence Grade 2 or 3 OA of the Kneen = —

Kolon TissueGene, Inc.·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Study to Determine the Safety and Efficacy of TG-C in Subjects With Kellgren and Lawrence Grade 2 or 3 OA of the Kneen = —

Kolon TissueGene, Inc.·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Effects of Intra-articular Hypertonic Dextrose and Hyaluronic Acid on Primary Knee Osteoarthritis.n = —

Bangladesh Medical University·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Osteoarthritis (OA) of the Kneen = —

Eli Lilly and Company·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoarthritis Lose Weight and Reduce Painn = —

Novo Nordisk A/S·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Treatment Effects of Subcutaneous Injections of Pentosan Polysulfate Sodium vs Placebo in Participants With Knee OA Painn = —

Paradigm Biopharmaceuticals USA (INC)·—·PHASE2/PHASE3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Autologous BMA vs Saline and LAM + LP-PRP vs Saline Evaluations in Knee OAn = —

University Health Network, Toronto·—·PHASE2/PHASE3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Phase II/III Randomized Trial of UC-MSC Secretome vs Sodium Hyaluronate in Knee Osteoarthritisn = —

Universitas Sriwijaya·—·PHASE2/PHASE3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

An Open-Label, Double-Treatment Group Study to Evaluate the Efficacy and Safety of Human Allogeneic Bone-Marrow- Derived Mesenchymal Stromal Cell Product StromaForte Compared With Hyaluronic Acid for the Treatment of Knee Osteoarthritisn = —

Cellcolabs Clinical SPV Limited·—·PHASE2/PHASE3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of PIP Joint Osteoarthritisn = —

TBF Genie Tissulaire·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Antarctic Krill Oil for Knee Osteoarthritis Painn = —

Qilu Hospital of Shandong University·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

The Safety/Efficacy of hUC Mesenchymal Stem Cells（19#iSCLife®-OA） Therapy for Patients With Osteoarthritisn = —

Sclnow Biotechnology Co., Ltd.·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Role of Methotrexate in Ultrasound Proven Synovitis in Primary Knee OAn = —

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Trial to Investigate the Safety and Efficacy of Intra-articular 4P004 Injection in Subjects With Knee Synovitis and Osteoarthritisn = —

4Moving Biotech·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Study to Assess the Efficacy and Safety of Vutiglabridin in Knee Osteoarthritis Patientsn = —

Glaceum·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritisn = —

University of Chicago·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of STT Osteoarthritisn = —

TBF Genie Tissulaire·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

The Effect and Safety of Anti-inflammatories and Dextrose Prolotherapy Injections in Treating Knee Osteoarthritisn = —

David Grant U.S. Air Force Medical Center·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

53-Week Study Evaluating the Safety and Efficacy of Intra-articular Injections of TPX-100 With Mild to Severe Tibio-Femoral Osteoarthritis of the Kneen = —

OrthoTrophix, Inc·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of Trapeziometacarpal Osteoarthritisn = —

TBF Genie Tissulaire·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Enhancing Modulation Effects of Baduanjin Through Neuromodulation for Knee OAn = —

Massachusetts General Hospital·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

An Study to Evaluate Safety and Tolerability of OA-SYS in Subjects With Moderate to Severe Osteoarthritis of the Knee Jointn = —

Ageless Biotech, Inc.·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Study to Assess Safety and Tolerability of PCRX-201 in Subjects With Painful Osteoarthritis of the Kneen = —

Pacira Pharmaceuticals, Inc·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Phase 1/2a to Evaluate the Safety and Efficacy of Adipose Tissue Allograft (BRC-OA) in Patients With Osteoarthritis of the Kneen = —

Britecyte·—·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

COntralateral CorticoSTeroid Injection in Total Knee Arthroplastyn = —

Unity Health Toronto·—·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Recombinant Human Growth Hormone (rHGH) for Knee Osteoarthritis (KORR)n = —

Dr. David Wasserstein·—·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Evaluation of Intra-articular CX-011 to Treat Moderate to Severe Pain From Knee Osteoarthritisn = —

CarthroniX, Inc.·—·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —