PTP-001 for Knee Osteoarthritis

(MOTION Trial)

Recruiting at 15 trial locations

Overseen By Mary Kathryn Kottke

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Doron Therapeutics Inc.

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

260 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a multicenter, prospective, randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of intra-articular administration of PTP-001 (MOTYS) for the treatment of knee osteoarthritis.

The purpose of the trial is to evaluate the efficacy, safety, and tolerability of a single intra-articular injection of PTP-001 compared to placebo over a 52-week period in participants with radiographic and symptomatic knee OA.

Who Is on the Research Team?

Professor David Hunter

Principal Investigator

Chair of Rheumatology at University of Sydney and Royal North Shore Hospital

Are You a Good Fit for This Trial?

Inclusion Criteria

My knee osteoarthritis symptoms started at least 6 months ago.

Willing to comply with study visit schedule and post-injection restrictions

Written informed consent is obtained from the participant

Exclusion Criteria

Clinically severe obesity as defined by the National Institutes of Health (body mass index ≥ 40 kg/m2) at Screening and / or Baseline

I have had radiation therapy on my target knee.

Severe (excessive) malalignment of the tibial-femoral axis assessed radiographically

What Are the Treatments Tested in This Trial?

Interventions

• PTP-001 (MOTYS™)

How Is the Trial Designed?

Group I: PTP-001 200 mg Experimental Treatment 1 Intervention

A single intra-articular injection in the target knee of PTP-001 200 mg

Group II: Placebo / saline vehicle Placebo Group 1 Intervention

A single intra-articular injection in the target knee of 4 mL of placebo control (0.9% sodium chloride injection, USP)

Who Is Running the Clinical Trial?

Doron Therapeutics Inc.

Lead Sponsor

Novotech (Australia) Pty Limited

Industry Sponsor

Trials

76

Recruited

7,800+

Dr. John Moller

Novotech (Australia) Pty Limited

Chief Executive Officer

MD and MBA from the University of Oxford

Dr. Judith Ng-Cashin

Novotech (Australia) Pty Limited

Chief Medical Officer since 2023

MD