A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Oral PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis

This is a Ph 2, randomized, double-blind, placebo-controlled global multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of PIPE-791 in subjects with a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) with or without background treatment.

Start Date08 Jan 2026

Sponsor / Collaborator

Contineum Therapeutics, Inc.

NCT06810245

/ CompletedPhase 1

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Crossover Multicenter Study to Explore the Safety and Efficacy of Oral PIPE-791 as Treatment in Subjects With Chronic Osteoarthritis Pain (COAP) or Chronic Low Back Pain (CLBP)

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 back pain (CLBP). The study will also explore whether PIPE-791 lowers pain in people with COAP or CLBP.
Subjects will:
* Complete a washout period to stop their current pain medications.
* Take a daily dose of PIPE-791 or placebo for 4 weeks, then reverse treatment assignment for another 4 weeks.
* Record pain levels and track dosing in a daily e-diary.
* Visit the clinic for checkups and lab tests throughout the study.
* Complete phone assessments during the treatment periods.

Start Date04 Feb 2025

Sponsor / Collaborator

Contineum Therapeutics, Inc.

NCT06683612

/ CompletedPhase 1

A Phase 1b, Open-label Study of PIPE-791 to Determine Brain and Lung Lysophosphatidic Acid Receptor 1 (LPA1) Occupancy, by [18F] PIPE-497 PET Imaging in Healthy Volunteers, Volunteers With Progressive Multiple Sclerosis, and Volunteers With Idiopathic Pulmonary Fibrosis

This is a study of PIPE-791, an investigational study drug to treat progressive multiple sclerosis (MS) and idiopathic pulmonary fibrosis (IPF). The purpose of this study is to find out how much of the study drug gets into the brain and lung, and what the side effects and blood levels of the study drug are in healthy volunteers and patients.
Participants will:
* Take a single dose of the study drug
* Give many samples of blood and urine
* Have multiple PET scans

Start Date09 Dec 2024

Sponsor / Collaborator

Contineum Therapeutics, Inc.

100 Clinical Results associated with PIPE-791

100 Translational Medicine associated with PIPE-791

100 Patents (Medical) associated with PIPE-791

Literatures (Medical) associated with PIPE-791

08 Jan 2026·Translational Vision Science & Technology

Pharmacological Blockade of LPAR1 Does Not Provide Neuroprotection in a Rat Model of Ocular Hypertensive Glaucoma

Article

Author: Lorrain, Daniel S. ; Nicol, Alan ; Tribble, James R. ; Kocherlakota, Sai ; Stebbins, Karin J. ; Locri, Filippo ; Williams, Pete A.

Purpose:

Current treatment strategies for glaucoma, the leading cause of irreversible blindness, only target intraocular pressure (IOP) but not the underlying retinal ganglion cell degeneration. IOP management is not always effective, necessitating neuroprotective strategies. Lysophosphatidic acid (LPA) is an extracellular signaling molecule implicated in modulating inflammation. It exerts its signaling effects through its receptors (LPAR1-6). Here we test the efficacy of PIPE-791, an LPAR1-selective antagonist, in conferring neuroprotection and modulating neuroinflammation in glaucoma.

Methods:

A bead-induced rat ocular hypertension (OHT) model of glaucoma was used to test PIPE-791 (administered intraperitoneally at 3 mg/kg dosing). We monitored IOP through tonometry and evaluated PIPE-791's neuroprotective capacity by studying retinal ganglion cell survival using cell counting and its effects on retinal vasculature, immune cell numbers and cytokine profile.

Results:

PIPE-791 had no effect on IOP in normotensive (NT) or OHT rat eyes. It also did not have any neuroprotective effect on retinal ganglion cell survival, nor did it normalize the changes in retinal vasculature observed in OHT retinas. Although PIPE-791 treatment increased microglial numbers in NT retinas, there was no effect in OHT retinas. Cytokine array profiling also revealed no significant effects for PIPE-791 on the cytokine changes between the NT and OHT retinas. These lack of changes could potentially be explained by the fact that LPAR1 protein levels are decreased in OHT retinas.

Conclusions:

Our data suggests that targeting LPAR1 through pharmacological means does not provide neuroprotection or modulate neuroinflammation favorably in glaucoma.

Translational Relevance:

Our study provides evidence that pharmacological targeting of LPAR1 as a potential therapeutic avenue in glaucoma may not be beneficial.

01 Dec 2025·NEUROPHARMACOLOGY

Reduced activation of pain-related brain regions with lysophosphatidic acid receptor subtype-1 antagonist PIPE-791 in a nonhuman primate model of chronic peripheral neuropathy

Article

Author: Hama, Aldric ; Okamoto, Ken ; Baccei, Christopher ; Poon, Michael ; Takamatsu, Hiroryuki ; Stebbins, Karin ; Itani, Yoshitaka ; Nozawa, Kenya ; Matsushita, Mayumi ; Chen, Austin ; Lorrain, Daniel S ; Natsume, Takahiro ; Kosugi, Tae

Lysophosphatidic acid (LPA) has been suggested to be a key mediator of painful peripheral neuropathy and blocking its action on LPA receptors could reduce symptoms by decreasing the neuroinflammatory cascade underlying neuropathic pain. The current study examined the effect of PIPE-791, a novel and potent LPA subtype-1 receptor (LPA1R) antagonist which has previously been shown to block demyelination in rodent preclinical models, on regional brain activation in response to non-noxious mechanical stimulation of the foot in male macaques with a unilateral right sciatic nerve injury. Thirteen days after nerve injury, stimuli that did not previously lead to activation in naïve macaques activated the anterior cingulate cortex (ACC) and contralateral insular/secondary somatosensory cortex (Ins/SII). Beginning two weeks after nerve injury, macaques were treated for 28 days with daily oral administration of PIPE-791 by gavage. Six weeks after nerve injury (one day after the last dose of PIPE-791) activation of the contralateral Ins/SII was reduced. Eight weeks after nerve injury (15 days after the last dose), activation of the ipsilateral thalamus, as well as activation of the ACC and contralateral thalamus and Ins/SII was observed. An overall pattern of elevated LPA species following nerve injury and decline with treatment was observed. Evoked brain activation could be related to painful peripheral neuropathy and reduced brain activation could be a direct indicator of reduced pain perception following treatment. The current findings suggest decreasing neuroinflammation by blocking LPA1Rs could be a novel approach to the management chronic painful peripheral neuropathy.

RESPIRATORY RESEARCH

The LPAR1 antagonist, PIPE-791 produces antifibrotic effects in models of lung fibrosis

Article

Author: Edu, Geraldine ; Lorrain, Kym ; Baccei, Christopher ; Valdez, Lino ; Lorrain, Daniel ; Schrader, Thomas ; Poon, Michael ; Stebbins, Karin ; Joseph, Gregory ; Broadhead, Alexander ; Xiong, Yifeng ; Roppe, Jeffrey ; Chen, Austin ; Bagnol, Didier

Abstract:

Background:

Idiopathic pulmonary fibrosis (IPF) is a chronic progressive form of interstitial lung disease (ILD) characterized by significant extracellular matrix deposition, alveolar damage, and tissue remodeling. Antagonists against the G-protein coupled receptor, lysophosphatidic acid receptor 1 (LPAR1) have shown efficacy in lung fibrosis preclinically and clinically. Here, we profile PIPE-791, a small molecule, orally bioavailable LPAR1 receptor antagonist, and show its effectiveness in several lung fibrosis-related contexts.

Methods:

In vitro, we used human lung fibroblasts and precision cut lung slices (PCLS) derived from donors with pulmonary fibrosis to test PIPE-791 efficacy in reducing markers of fibrosis. In vivo, we used bleomycin-induced lung fibrosis models to demonstrate PIPE-791 efficacy.

Results:

In vitro PIPE-791 reduced LPA-induced collagen expression (IC50 1.1 nM) in human lung fibroblasts. We also show that LPAR1 is elevated in IPF lung tissue and that PIPE-791 significantly reduced several markers of lung fibrosis in PCLS as measured by gene expression and secreted biomarkers. Using in vivo receptor occupancy, we found that PIPE-791 has long association kinetics resulting in a 20-fold increase in potency when dosed 3 versus 24 h prior to radioligand administration. At 3 mg/kg, PIPE-791 was effective in significantly reducing markers of fibrosis and collagen expression in mouse bleomycin models.

Conclusions:

We show that PIPE-791 effectively reduces fibrosis and fibrotic markers in vitro and in vivo and that it has slow association and dissociation kinetics. Taken together, our data support clinical testing of PIPE-791 in the context of fibrotic conditions such as IPF.

News (Medical) associated with PIPE-791

01 Jun 2026

·ir.contineum-tx.com

Contineum Therapeutics to Present at the 2026 Goldman Sachs Global Healthcare Conference

SAN DIEGO --(BUSINESS WIRE)--Jun. 1, 2026-- Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the Company), a clinical-stage biopharmaceutical company pioneering differentiated therapies for the treatment of neuroscience, inflammation and immunology (NI&I) indications, today announced that management is scheduled to present at the 2026 Goldman Sachs Global Healthcare Conference on Tuesday, June 9th at 1:20 p.m. ET . An audio webcast of the fireside chat can be accessed on the Investors section of Contineum’s website. A webcast replay will also be available. About Contineum Therapeutics Contineum Therapeutics (Nasdaq: CTNM) is a clinical-stage biopharmaceutical company pioneering novel, oral small molecule therapies for NI&I indications with significant unmet need. Contineum is advancing a pipeline of internally-developed programs with multiple drug candidates now in clinical trials. PIPE-791 is an LPA1 receptor antagonist in clinical development for idiopathic pulmonary fibrosis and chronic pain. PIPE-307 is a selective inhibitor of the M1 receptor in clinical development for relapsing-remitting multiple sclerosis and major depressive disorder. For more information, please visit www.contineum-tx.com. View source version on businesswire.com: https://www.businesswire.com/news/home/20260601133303/en/ Steve Kunszabo Contineum Therapeutics Senior Director, Investor Relations & Corporate Communications 858-649-1158 skunszabo@contineum-tx.com Source: Contineum Therapeutics, Inc.

17 May 2026

·www.biospace.com

Contineum Therapeutics Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4) - May 15, 2026

SAN DIEGO--(BUSINESS WIRE)--Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the Company), a clinical-stage biopharmaceutical company pioneering differentiated therapies for the treatment of neuroscience, inflammation and immunology (NI&I) indications, today announced that on May 14, 2026 (Grant Date), the Compensation Committee of the Company’s Board of Directors granted an inducement award consisting of a non-qualified stock option to purchase 51,000 shares of Class A common stock to one new non-executive employee under the Company’s 2026 Employment Inducement Equity Incentive Plan. The award was granted as an inducement material to the new employee’s employment in accordance with Nasdaq Listing Rule 5635(c)(4). The stock option has an exercise price equal to the closing price of the Company’s Class A common stock on the Grant Date, and will vest over 4 years, with 25% of the underlying shares vesting on the one-year anniversary of the applicable vesting commencement date and the balance of the underlying shares vesting monthly thereafter over 36 months, subject to the new non-executive employee’s continued service with the Company through the applicable vesting dates. The stock option has a ten-year term and is subject to the terms and conditions of the Company’s 2026 Employment Inducement Equity Incentive Plan, and the terms and conditions of an applicable stock option agreement covering the grant. About Contineum Therapeutics Contineum Therapeutics (Nasdaq: CTNM) is a clinical-stage biopharmaceutical company pioneering novel, oral small molecule therapies for NI&I indications with significant unmet need. Contineum is advancing a pipeline of internally-developed programs with multiple drug candidates now in clinical trials. PIPE-791 is an LPA1 receptor antagonist in clinical development for idiopathic pulmonary fibrosis and chronic pain. PIPE-307 is a selective inhibitor of the M1 receptor in clinical development for relapsing-remitting multiple sclerosis and major depressive disorder. For more information, please visit . Contacts Steve Kunszabo Contineum Therapeutics Senior Director, Investor Relations & Corporate Communications 858-649-1158 skunszabo@contineum-tx.com

Fast TrackClinical Result

12 May 2026

·ir.contineum-tx.com

Contineum Therapeutics to Present at the 2026 RBC Capital Markets Global Healthcare Conference

SAN DIEGO --(BUSINESS WIRE)--May 12, 2026-- Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the Company), a clinical-stage biopharmaceutical company pioneering differentiated therapies for the treatment of neuroscience, inflammation and immunology (NI&I) indications, today announced that management is scheduled to present at the 2026 RBC Capital Markets Global Healthcare Conference on Tuesday, May 19th at 3:35 p.m. ET . An audio webcast of the fireside chat can be accessed on the Investors section of Contineum’s website. A webcast replay will also be available. About Contineum Therapeutics Contineum Therapeutics (Nasdaq: CTNM) is a clinical-stage biopharmaceutical company pioneering novel, oral small molecule therapies for NI&I indications with significant unmet need. Contineum is advancing a pipeline of internally-developed programs with multiple drug candidates now in clinical trials. PIPE-791 is an LPA1 receptor antagonist in clinical development for idiopathic pulmonary fibrosis and chronic pain. PIPE-307 is a selective inhibitor of the M1 receptor in clinical development for relapsing-remitting multiple sclerosis and major depressive disorder. For more information, please visit www.contineum-tx.com. View source version on businesswire.com: https://www.businesswire.com/news/home/20260512847258/en/ Steve Kunszabo Contineum Therapeutics Senior Director, Investor Relations & Corporate Communications 858-649-1158 skunszabo@contineum-tx.com Source: Contineum Therapeutics, Inc.

100 Deals associated with PIPE-791

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Idiopathic Pulmonary Fibrosis	Phase 2	Australia	Contineum Therapeutics, Inc.	08 Jan 2026
Idiopathic Pulmonary Fibrosis	Phase 2	Canada	Contineum Therapeutics, Inc.	08 Jan 2026
Idiopathic Pulmonary Fibrosis	Phase 2	Israel	Contineum Therapeutics, Inc.	08 Jan 2026
Idiopathic Pulmonary Fibrosis	Phase 2	South Korea	Contineum Therapeutics, Inc.	08 Jan 2026
Idiopathic Pulmonary Fibrosis	Phase 2	United Kingdom	Contineum Therapeutics, Inc.	08 Jan 2026
Chronic osteoarthritis	Phase 1	United States	Contineum Therapeutics, Inc.	04 Feb 2025
Low Back Pain	Phase 1	United States	Contineum Therapeutics, Inc.	04 Feb 2025
Multiple Sclerosis, Chronic Progressive	Phase 1	United Kingdom	Contineum Therapeutics, Inc.	09 Dec 2024
Multiple Sclerosis, Primary Progressive	Phase 1	United Kingdom	Contineum Therapeutics, Inc.	09 Dec 2024
Multiple Sclerosis, Secondary Progressive	Phase 1	United Kingdom	Contineum Therapeutics, Inc.	09 Dec 2024

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