PIPE-791 for Osteoarthritis and Low Back Pain

Not currently recruiting at 4 trial locations

Overseen By Jules Lee

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Contineum Therapeutics

Must not be taking: Capsaicin

Disqualifiers: Fibromyalgia, Rheumatoid arthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new treatment, PIPE-791, is safe and effective in reducing pain for individuals with chronic osteoarthritis pain or chronic low back pain. Participants will take either PIPE-791 or a placebo for four weeks, then switch treatments for another four weeks, tracking their pain levels daily. This trial may suit those who have experienced daily pain from osteoarthritis of the knee or low back pain for at least six months. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

Yes, you will need to stop taking your current pain medications before starting the trial. There is a washout period (time without taking certain medications) to ensure this.

Is there any evidence suggesting that PIPE-791 is likely to be safe for humans?

Research shows that PIPE-791 is currently being tested for safety and effectiveness in treating chronic osteoarthritis pain (COAP) and chronic low back pain (CLBP). As this is an early testing stage, the main goal is to assess tolerability and identify any side effects. While long-term safety data is limited, this phase helps researchers understand initial reactions in participants. Detailed data on side effects is not yet available, but this trial aims to gather that crucial information. Prospective participants should know that the trial is designed to carefully monitor safety at every step. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

PIPE-791 is unique because it introduces a novel approach to treating osteoarthritis and low back pain by targeting specific pathways associated with inflammation and pain, unlike traditional treatments like NSAIDs and opioids, which primarily manage symptoms. Researchers are excited about PIPE-791 because it promises to address the underlying causes of pain more effectively, potentially offering longer-lasting relief without the side effects commonly associated with current medications. Additionally, PIPE-791's mechanism of action could provide a more targeted treatment option, reducing the risk of dependency and tolerance often seen with conventional pain management drugs.

What evidence suggests that PIPE-791 might be an effective treatment for osteoarthritis and low back pain?

This trial will evaluate PIPE-791 for its potential to reduce pain in individuals with chronic osteoarthritis pain (COAP) and chronic low back pain (CLBP). Participants will be assigned to different treatment arms, receiving either PIPE-791 followed by a placebo or a placebo followed by PIPE-791. While direct evidence of its effectiveness is not yet available, PIPE-791 is designed to target specific areas involved in pain and swelling, potentially lowering pain. Early results from similar studies suggest promise, but further research is necessary for confirmation. Current studies primarily focus on assessing the drug's safety and tolerability. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 with chronic osteoarthritis knee pain or low back pain, who've had daily pain for at least 6 months. Participants must stop current pain meds and maintain any non-drug therapies they're using. They need recent x-rays showing their condition and a BMI under 40. Those who can have children must use effective birth control during the study.

Inclusion Criteria

I have had knee osteoarthritis or low back pain for at least 6 months.

Body mass index <40 at Screening

Ability to use an eDiary to record daily pain scores

Exclusion Criteria

Demonstrated noncompliance recording daily Numerical Rating Scale (NRS) scores during Screening

I am scheduled for surgery during the study, related or not to my current condition.

I was diagnosed with osteoarthritis as a child or teen.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Washout

Participants undergo a washout period to stop their current pain medications

2 weeks

Treatment Period 1

Participants receive either PIPE-791 or placebo daily for 4 weeks

4 weeks

Regular clinic visits and phone assessments

Treatment Period 2

Participants crossover to the alternate treatment assignment for an additional 4 weeks

4 weeks

Regular clinic visits and phone assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Post-treatment safety follow-up/end of study phone visit

What Are the Treatments Tested in This Trial?

Interventions

• PIPE-791

Trial Overview The trial tests PIPE-791's safety and effectiveness in reducing chronic osteoarthritis or low back pain compared to a placebo. Participants will take PIPE-791 or placebo for four weeks, switch treatments for another four weeks, keep an e-diary of their pain levels, attend clinic visits, and do phone assessments.

How Is the Trial Designed?

Group I: Placebo followed by Active Experimental Treatment 2 Interventions

Group II: Active followed by Placebo Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Contineum Therapeutics

Lead Sponsor

Trials

7

Recruited

400+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06810245

Study of PIPE-791 for Subjects With Chronic Osteoarthritis ... The primary goal of this clinical trial is to learn if PIPE-791 is safe and well-tolerated in adults with chronic osteoarthritis pain (COAP) or chronic low ...

2. ir.contineum-tx.com ir.contineum-tx.com/news-releases/news-release-details/contineum-therapeutics-expands-clinical-development-pipe-791-fda

Release Details Contineum anticipates topline data from the PIPE-791 Phase 1b chronic pain study in early 2026.

3. withpower.com withpower.com/trial/pipe-791-for-osteoarthritis-and-low-back-pain-1df85

PIPE-791 for Osteoarthritis and Low Back Pain PIPE-791. Trial Overview The trial tests PIPE-791's safety and effectiveness in reducing chronic osteoarthritis or low back pain compared to a placebo.

4. firstwordpharma.com firstwordpharma.com/story/6512089

Contineum Therapeutics Reports Third-Quarter 2025 ... PIPE-791 is being evaluated for the treatment of patients with chronic osteoarthritis pain and chronic lower back pain. More information on ...

5. ir.contineum-tx.com ir.contineum-tx.com/news-releases/news-release-details/contineum-therapeutics-initiates-patient-dosing-phase-1b-chronic

Release Details PIPE-791 is being evaluated for the treatment of chronic pain associated with two separate indications, osteoarthritis (OA) and low back pain (LBP).

6. synapse.patsnap.com synapse.patsnap.com/drug/f719f2d5263049f8a1ceb41b9ccd7d01

PIPE-791 - Drug Targets, Indications, Patents A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Escalating Single and Multiple Doses of PIPE_791 and ...

7. ainvest.com ainvest.com/news/contineum-therapeutics-pipe-791-dual-threat-potential-chronic-pain-fibrosis-2506/

Contineum Therapeutics: PIPE-791's Dual-Threat Potential ... The drug is currently in Phase 1b clinical trials for chronic pain (osteoarthritis, low back pain) and fibrotic diseases (idiopathic pulmonary fibrosis, ...