Forum Topics PAR PAR ASX Announcements

Pinned straw:

Added 8 months ago

This is progress but also highlights the slow progress the business is making. They would have been disappointed to have had to go back and provide this evidence to the FDA but having got it together is obviously good. Unfortunately it's still a way from phase 3 trial results which is the endgame here. I'm confident from the evidence already released that the drug works but the cashburn is unbelievable and they JUST NEED TO GET THEIR PHASE 3 TRIAL DONE! argh. So frustrated.



ASX RELEASE 19 April 2024

PARADIGM CONFIRMS SUBMISSION TO THE US FDA

TO PROGRESS THE PHASE 3 OA PROGRAM

Paradigm Biopharmaceuticals Ltd (ASX:PAR) (“Paradigm” or “the Company”), a

late-stage drug development company focused on delivering new therapies to address

unmet medical needs, is pleased to announce the submission of key documents to the

US Food and Drug Agency (FDA, the Agency) for review and agreement on the

progression of the phase 3 clinical program in osteoarthritis.

Paradigm has submitted to the US FDA a response to the Type D meeting held on 10

January 2024.

Paradigm’s response sets out the results of five nonclinical studies and data from the

successful phase 2 clinical trial, PARA_OA_008, as well as available clinical data from

600 participants dosed in stage 1 of PARA_OA_002. These additional data were collected

following Paradigm’s Investigational New Drug (IND) submission to the Agency in March

2021 (see ASX release), most of which have not previously been submitted nor reviewed

by the FDA. These data provide a detailed justification for the clinical development for

iPPS with the dosing regimen of 2 mg/kg twice weekly for 6 weeks of initial therapy.

Paradigm also submitted a draft of the phase 3 pivotal clinical trial protocol for agency

review and comment.

The response package to the US FDA has been submitted as directed by the Agency,

through a request for review pathway. The request for review pathway does not have

strict Prescription Drug User Fee Act (PDUFA) Agency response timelines, although

feedback is typically received within three months.

The key items addressed in the Type D response submission to the FDA include:

• The minimal effective dose justification.

• Additional nonclinical studies completed to GLP standards to address previously

noted adrenal findings.

• Draft clinical trial protocol.

• Revised safety monitoring and mitigation plan.

Subject to FDA clearance, Paradigm intends to promptly move forward with subject

enrolment into the phase 3 clinical trial (PARA_OA_012) in 2H CY2024. Clinical trial sites

in Australia and the US are planned to commence preparation activities during this quarter

(Q2 CY2024) to move the phase 3 program forward as quickly and efficiently as possible.

Paradigm Managing Director, Mr Paul Rennie commented: “This is important progress

for Paradigm as we deliver a significant amount of new data to the US FDA for review to

progress to the next stage of the phase 3 OA program. Since Paradigm’s IND submission

in March 2021, we have treated close to 700 participants under a clinical trial setting with

various iPPS doses, which provides strong justification that 2 mg/kg twice weekly is the

lowest effective dose with which to move forward. We look forward to receiving the FDA’s

feedback and remain ready to answer any further questions. We look forward to updating

all our investors in the coming months on the outcome of the agency's review and planned

execution of the phase 3 clinical program. I would like to thank our investors for their

ongoing support as we strive to bring the exciting potential of iPPS to market for those

suffering with osteoarthritis.”

Next Steps

Paradigm will now finalise the TGA provisional approval determination application for

submission. The determination application will include information from a manuscript

detailing the outcomes from the PARA_OA_008 phase 2 clinical trial and a manuscript

providing a comparison of iPPS clinical data with other available treatments for

osteoarthritis. Should the determination application decision be positive, Paradigm will

prepare a full dossier submission for TGA provisional approval marketing authorisation.

Provisional approval offers significant benefits to both patients and manufacturers.

Patients gain access to potential life-saving treatments for life-threatening and seriously

debilitating conditions sooner, particularly for those lacking satisfactory alternatives. For

manufacturers, it provides an opportunity to bring innovative therapies to market faster,

while gathering additional data to support full approval. TGA provisional marketing

approval for iPPS in Australia would expedite the pathway to revenues. The completed

manuscripts are being prepared and will be submitted to separate journals for peer-review

and publication.

-Ends-

About Paradigm Biopharmaceuticals Ltd.

Paradigm Biopharmaceuticals Ltd. (ASX:PAR) is a late-stage drug development

company driven by a purpose to improve patients’ health and quality of life by discovering,

developing, and delivering pharmaceutical therapies. Paradigm’s current focus is

developing injectable (subcutaneous) pentosan polysulfate sodium (iPPS) for the

treatment of diseases where inflammation plays a major pathogenic role, indicating a

need for the anti-inflammatory and tissue regenerative properties of iPPS, such as in

osteoarthritis (phase 3) and mucopolysaccharidosis (phase 2).

Forward Looking Statements

This Company announcement contains forward-looking statements, including statements

regarding anticipated commencement dates or completions dates of nonclinical or clinical

trials, regulatory developments, and regulatory approval. These forward-looking

statements are not guarantees or predictions of future performance, and involve known

and unknown risks, uncertainties, and other factors, many of which are beyond our

control, and which may cause actual results to differ materially from those expressed in

the statements contained in this presentation. Readers are cautioned not to put undue

reliance on forward-looking statements.

To learn more please visit: https://paradigmbiopharma.com

Approved for release by the Paradigm Board of Directors.

FOR FURTHER INFORMATION PLEASE CONTACT:

Simon White

Director of Investor Relations

Tel: +61 404 216 467

Paradigm Biopharmaceuticals Ltd

ABN: 94 169 346 963

Level 15, 500 Collins St, Melbourne, VIC, 3000, AUSTRALIA

Email: [email protected]


Summer12
Added 8 months ago

I feel your pain @GazD

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