Paradigm Biopharmaceuticals Ltd (ASX: PAR) is an ASX listed healthcare company, focusing on repurposing pentosan polysulphate sodium (PPS) for the treatment of medical conditions that have an active role in inflammation. The important properties of the activity of PPS are its tissue regenerative and anti-inflammatory properties.
On 8th May 2019, the company released an update regarding clinical programs and commercial progress.
Material reductions in bone marrow lesions
Bone marrow lesions (BML) are identified through excessive water signals in the marrow space. They are a significant source of pain and linked to increased disease activity in many musculoskeletal conditions.
Bone marrow lesions in subchondral bone of people with knee osteoarthritis are linked to pain and progression of cartilage loss over time. Previous results of Paradigm’s phase 2b clinical trial demonstrated a clinically meaningful reduction in BML Grade among the group of patients who received injectable Pentosan Polysulfate (iPPS).
The company has now reported significant reductions in BML in sites of the body other than the knee using iPPS under the TGA special access scheme. The other sites included hip, knee cap and ankle. Further, the company is observing the whole-body effect of iPPS. The company is focused on the treatment of OA of the knee for its upcoming phase 3 trial, which also demonstrates the potential of iPPS for treatment on all sites affected by bone marrow lesions.
The manufacturing phase of iPPS has been completed, which will support the upcoming requirements under its phase 3 OA and MPS trials and its requirements under TGA special access and FDA compassionate use.
Paradigm’s upcoming IND filings with the FDA would require the batch records of manufacturing completion and ownership.
The application for compassionate use of iPPS to the FDA is expected to be submitted in the coming weeks. Upon its successful approval, the company will be able to the treat up to 50 past NFL football players in the US. The first 10 NFL players have agreed for receiving the treatment and sites have been identified as well. The result for the treatment is expected to be visible in late 3Q19 period.
Paradigm’s main OA competitor
One of the main competitors of the company for the treatment of Osteoarthritis (OA) was Tanezumab, nerve growth factor antibody. Recently, it had conducted phase 3 trial results which showed neither of the two dosage levels met all co-primary efficacy goals and both doses fared worse than placebo on safety.
Conclusion of $77.9 million capital raising and further catalysts
PAR has successfully completed the capital raising of $77.9 million via placement and institutional entitlement offer. It is now focusing on delivering on its pipeline of catalysts for 2019, some of which are as follows:
- Appointment of highly regarded US-based CMO – in Q2 CY2019.
- Ross River Phase 2a (safety study) trial results release – during Q2/Q3 CY2019.
- Possibility of being acknowledged with “fast track status” for phase 3 OA trial.
- File IND and meet with FDA re phase 3 trial in OA - Q3 CY2019.
- File IND for pivotal Phase 2/3 for Mucopolysaccharidosis (MPS) – in Q2 CY2019.
On 13th March 2019, the company published its investor presentation stating all the operational updates and future catalysts for 2019.
The stock of the company last traded at A$1.510, down by 1.307% (as on 8 May 2019) from its previous close. The market capitalisation of the company is A$277.24 million. The 52-week high and low of the stock is A$2.149 and A$0.381 respectively. In the last one year, the stock has delivered a good return of 291.6%, and the YTD return stands at 54.35%.
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