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Paradigm Biopharmaceuticals

Developing innovativetherapies forinflammatory diseases

Paradigm Biopharmaceuticals is a late-stage clinical biopharmaceutical company focused on developing differentiated therapies for diseases with significant unmet medical need.

Listed
ASX: PAR
Phase 3 participants
538
Trial sites
57
FDA Fast Track
2022

Our development model: From opportunity to patient impact

Five stages take a proven molecule from a scientific hunch to a treatment in a patient's hands.

We look for molecules with real scientific rationale behind them and a disease with no good answer. Starting from a compound already proven safe in people means the question is efficacy, not whether it can be given to a patient at all.

Molecular structure render
Patient being positioned for an MRI scan
Clinician examining a patient's knee
Researcher at a microscope
Pentosan polysulfate sodium molecule render

Project Timeline

Clinical Development Journey 2018–2024

2018

Successful Phase 2b

100% recruitment achieved and successful clinical trial readout.

2020

Regulatory Consultation

Pre-IND meeting with US FDA and EMA Scientific Advice Meeting completed.

2021

Phase 2 Initiation

Clinical study PARA_OA_008 formally initiated.

2023

Primary Endpoint Met

Phase 2 meets primary endpoint; Fast track designation granted for Phase 3 program.

2023

MRI Data Analysis

Completion of 12-month duration study with positive 6-month MRI data results.

2024

Phase 3 FDA Clearance

Phase 3 protocol submitted and successfully cleared by the US FDA.

Our values: The principles that guide every decision we make

Transparency

We communicate clearly, consistently and responsibly, providing stakeholders with timely and balanced information on our progress, challenges and outcomes.

Accountability

We take responsibility for our decisions, commitments and performance, with a focus on disciplined execution and delivering against clearly defined objectives.

Collaboration

We work closely with clinicians, patients, research partners, regulators and manufacturing partners to advance our programs efficiently and responsibly.

Respect

We recognise the contribution of every patient, clinician and partner involved in our development programs, and place patient wellbeing and scientific integrity at the centre of our decisions.

Adaptability

We respond to emerging evidence, regulatory guidance and development learnings, adapting our approach where required to improve outcomes and reduce execution risk.

Innovation

We apply scientific insight and disciplined development to identify new therapeutic potential in established molecules, with the aim of addressing significant unmet medical needs.

Global trial footprint: one Phase 3 programme, four countries

Corporate headquarters in Melbourne, and 65 Phase 3 sites delivered with CRO partners Advanced Clinical and NBCD A/S.

Our capabilities

Deep expertise across the development lifecycle, from first evaluation to established supply.

Clinical development

Designing and running global trials to a pre-agreed endpoint. PARA_OA_012 recruited 538 participants across 65 sites in four countries.

Regulatory strategy

Several regulators on one programme. FDA Fast Track designation was granted in 2022 for knee osteoarthritis.

Biomarkers & translational science

Patient-reported outcomes paired with imaging and structural markers, so a result can be read in more than one way.

Manufacturing & CMC

The compound is already produced at scale by established suppliers, so supply is a solved problem rather than the last hurdle.

Drug reformulation

Reworking how an established molecule is delivered so it can reach a new indication. The molecule is not new; the route and the target are.

Strategic partnerships

Partners with existing manufacturing, regulatory and commercial reach are how a treatment gets from a positive result to a patient.

Our partners

Working with established partners across development, manufacturing, regulatory strategy and translational research.

bene pharmaChem
NBCD
Cytel