From Bell Potter -Biomarker Data Remains Highly SupportivePAR...

From Bell Potter -

Biomarker Data Remains Highly Supportive

PAR continues to make every post a winner with the latest data from the company’s
phase 2 randomised clinical trial providing further evidence of efficacy and safety for
iPPS. PARA_OA_008 was designed to generate data to test the hypothesis that
changes in the biomarkers correlate with knee pain reduction and improved knee
function. The key data released today concerned the secondary endpoints of
radiographic changes in bone/ joint together with further data on biomarkers.
Imaging showed a material improvement in cartilage degradation for participants on
drug vs control. Both the once weekly and twice weekly dose groups showed trends of
improvement in cartilage preservation compared to control with the once weekly dose
cohort achieving statistical significance despite small participant numbers.
A broad panel of potential biomarkers in blood, urine and synovial fluid were assessed.
Participants on treatment showed persistent beneficial effects of iPPS compared to
placebo. In the company’s view the biomarkers indicate cartilage sparing changes in
iPPS subjects compared to placebo.

Where to now

PAR will use the data to request a Type D meeting with the FDA in order to seek
guidance regarding the adequacy of its proposed endpoints in the upcoming phase 3
trials to support a future label claim for a disease modifying osteoarthritis drug
(DMOAD). If successful iPPS would be the first ever drug to attain this status. If the
label claim ultimately includes DMOAD, this may have significant implications for
revenues and valuation. Enrolment of the phase 3 program is continuing as planned.

Investment View: Buy (Speculative), Valuation $2.20

We retain our Buy (Speculative) rating and valuation of $2.20. The next major catalyst
will include the 12-month data from PARA_OA_008 later this year.