Paradigm Biopharmaceuticals Ltd (ASX:PAR) has delivered its June quarter activities report recording additional new avenues for Zilosul® and several other programs in the pipeline.
The highlight of the quarter was the first revenue generated by Paradigm for the provision of Zilosul® to prescribing physicians under the therapeutic goods administration (TGA) special access scheme (SAS).
Zilosul® was made available during the second quarter to physicians with SAS approval to treat patients experiencing chronic arthralgia from Ross River virus (RRV) infection.
In addition, the first subject dosing in the exploratory synovial fluid biomarker study, PARA_OA_008, was reported during the second quarter, with the study designed to generate clinical data and biomarker data to further inform Paradigm of the potential for Zilosul® as the first in class disease-modifying drug for osteoarthritis.
Largest clinical trial conducted using pentosan polysulphate
Paradigm confirms ethics approval has been received from the institutional ethics committee in the US and the company is finalising approval with the Australian ethics committee for its pivotal study in knee osteoarthritis.
In Brazil, regulatory approval was received from Brazil’s National Health Surveillance Agency and ethics approval from the National Research Ethics Commission for a phase two clinical trial evaluating safety and tolerability of injectable Pentosan Polysulfate Sulfate (iPPS) versus placebo in subjects with Mucopolysaccharidosis (MPS) type VI.
This will be the largest clinical trial conducted using pentosan polysulphate (PPS) in any MPS type subjects.
Paradigm’s MPS program has received Orphan Drug Designation status in the US and European Union for MPS I and MPS VI.
During the quarter, Paradigm filed two additional patents for the use of PPS in Acute Respiratory Distress Syndrome (ARDS).
In addition, Paradigm expects communication from the Food and Drug Administration (FDA) no earlier than July 30, 2021, for its investigational new drug application.
Financials
Paradigm’s cash balance as of 30th June 2021 was $71.1 million compared to $81.1 million in the previous corresponding quarter, with a net cash outflow during the quarter of $10 million.
Research and development expenditure (R&D) for the quarter totalled $8.04 million, compared to the previous quarter's $6.18 million result.
The research and development expenditure is attributed to Paradigm's PARA_OA_002 and PARA_OA_008 trials and the MPS I and MPS VI clinical programs.
In addition, Paradigm received an R&D tax rebate of $1.3 million in July 2021.
Future outlook
Paradigm's Para_OA_008 study recruitment remains ongoing with some minor delays due to multiple lockdown measures in Victoria that have occurred during the trial period. The company expects to provide an update on the Para_OA_008 trial during the September quarter.
Paradigm’s Chikungunya Virus (CHIKV) manuscript has also completed the final feedback round with the peer-reviewers and is anticipated the pre-clinical data will be published online during the fourth quarter of CY2021.
The pre-clinical proof-of-concept study for the company’s pipeline indication in ARDS is nearing completion, with data being processed at the Menzies Institute in Queensland.
The pre-clinical proof-of-concept study for the company’s pipeline indication in chronic heart failure is also nearing completion, with data being processed at a leading CRO in France.
Paradigm expects to provide some top-line data and commentary on the completed studies during the fourth quarter of 2021.