Paradigm Biopharmaceuticals Ltd (ASX:PAR) is fully funded with $78 million as it progresses development and potential commercialisation of injectable PPS (iPPS) for three indications - Osteoarthritis (OA), Mucopolysaccharidosis (MPS) and Ross River virus (RRV).
The company is on track to file pre-Investigational New Drug (IND) meeting packages for IND applications with US FDA in leading indications of OA and the Orphan indication for MPS.
Pending successful phase 3 trials, both OA and MPS have the potential to be significant commercial opportunities for Paradigm.
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Paradigm’s absolute focus is on the clinical development and commercialisation of iPPS for the indications of OAs, the orphan indication of MPS and Alphavirus infections such as RRV and Chikungunya (CHIKV).
With the phase 2b trial in OA, Paradigm has moved through a critical value inflection point by successfully passing both its primary and secondary endpoints.
Multiple confidentiality agreements (CA) have been signed and discussions are progressing with potential partners for OA and MPS while progressing towards its IND filings and potential start of the pivotal phase 3 trial.
Injectable PPS is not registered in Australia, but it is registered in four of the seven major global pharmaceutical markets.
Based on the strength of data from the Ross River trial, Paradigm intends to enter into discussions with US Department of Defense and other potential partners for potential further development of iPPS in alphavirus infections.
The company has completed a Good Manufacturing Practice (GMP) manufacturing campaign providing supply of iPPS to be used in forthcoming phase 3 trials, TGA special access scheme (SAS) and expanded access program (EAP) for treatment of ex-NFL players in the US.
Paradigm expects to file an initial submission for Provisional Approval with the Australian TGA which, if approved, would provide potential first revenue and sales in Australia.
New staff members
To facilitate its ongoing development and growth, the company has also signed employment agreements with five new staff members, including a New York-based chief medical officer.
Other key appointments are a global head of clinical development, global head of regulatory affairs, associate director of regulatory affairs and project manager of clinical operations.
These appointments will help to create a global clinical and regulatory team to execute Paradigm’s clinical programs and undertake its filings with the US FDA and other Regulatory Agencies in the remainder of 2019.
Q2 milestones achieved
- Pain reduction Mechanism of Action (MoA) of iPPS in osteoarthritis complete and manuscript has been sent for peer review and publication.
- Reported on 205 patients treated by their doctor under the TGA SAS with an average pain reduction of > 50% from baseline.
- Reported on the successful phase 2a Ross River Clinical Trial.
- Employed 5 new clinical and regulatory staff;
- Completed cGMP Manufacturing of phase 3 product.
- Face-to-Face Meetings with Key Pharmaceutical Companies in Europe and Japan.
- Completed the successful capital raise which strengthened the shareholder register; and
- Established a scientific advisory committee for Orphan indication for the rare disease MPS.
Timeline for value inflexion points
- File Expanded Access Program (EAP) for 10 ex-NFL players with US FDA - Q3 2019;
- File submission with the TGA for Provisional Approval Application of Zilosul for treatment of osteoarthritis - Q3 2019;
- Pre-IND meeting with US FDA Orphan Indication (MPS) Phase 2/3 clinical Trial - CY 2019;
- Pre-IND Meeting with US FDA Osteoarthritis Phase 3 Clinical Trial - Q4 2019;
- Commercial discussions – ongoing; and
- Discussions with US DoD – ongoing.