Good news

Good morning, Multiple signals at 6-months show that iPPS may slow disease progression in knee osteoarthritis along with durable reduction in pain and improvement in function. Paradigm Biopharma (PAR) this morning release new top-line data from the 6-month follow up of the Phase 2 clinical study exploring the Disease Modifying potential of injectable PPS in knee OA. The new novel data demonstrates a significant outcome for Paradigm, confirming iPPS is not only providing pain relief and functional improvement for OA patients, but also demonstrating in this small trial that it is slowing the progression of the disease. View the full announcement HERE The data released today is top-line in nature however, several strong trends or statistical significance are provided for structural measures observed through MRI, reduction of key biomarkers associated with cartilage breakdown and a durable reduction in pain and improvement in function at 6-month after patients having the first iPPS injection. Independent global market research conducted in 2021 stated that a DMOAD label for iPPS would:Significantly increase price per treatment course.Physicians would be more likely to use iPPS as a first-line therapy.= even higher revenue potential. Paradigm Managing Director and Chairman, Paul Rennie also commented: “A non-opioid drug for treating the symptoms of osteoarthritis (pain and joint stiffness) with durability of effect out to 168 days (6 months) plus signals of disease modifying potential, is well poised to address a major unmet medical need. These data are expected to assist our partnering discussions.” Highlights from today’s release: · Day 168 data from Paradigm’s phase 2 PARA_OA_008 clinical trial demonstrates multiple signals that injectable pentosan polysulfate sodium (iPPS) may slow disease progression in knee osteoarthritis (OA).· Structural changes as measured by magnetic resonance imaging (MRI) were consistent with potential DMOAD activity. iPPS demonstrated 21% improvement in mean cartilage loss score compared to 4% worsening in the placebo group, o Statistically significant reductions in bone marrow edema lesions compared to placebo, ando Reduction of marginal osteophytes compared to increases in the placebo group. · The disease modifying OA drug (DMOAD) potential for iPPS in knee OA treatment is also supported by changes and trends in four key biomarkers (ARGS, COMP, C2C, and CTX-II) evaluated in this phase 2 study. · Persistent positive clinical responses in WOMAC pain, function, stiffness and overall WOMAC scores have been observed in the twice-weekly iPPS compared to placebo to Day 168.o In addition to durable pain responses, the average number of days participants used rescue medication was four times higher in the placebo group (23 days) compared to the twice-weeklyiPPS group (5 days) to Day 168. · The results of these new MRI, molecular biomarker and clinical outcomes will be presented to the Regulatory Authorities (FDA and EMA). Paradigm will seek their input as to what additional data, from a larger controlled study (PARA_OA_003), may be required to obtain a DMOAD label.