PIPE-791 / Contineum Therap - LARVOL DELTA

Contineum Therapeutics Reports First-Quarter 2025 Financial Results; Affirms Key Clinical Development Milestones (Businesswire) - "Topline data from PIPE-791 Phase 1b positron emission tomography (PET) trial expected in the second quarter of 2025; PIPE-791 chronic toxicity studies completed to support future Phase 2 trials; Topline data from PIPE-307 Phase 2 VISTA trial for the treatment of relapsing-remitting multiple sclerosis (RRMS) anticipated in the second half of 2025...The Company plans to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for CTX-343 in the second half of 2025."

Clinical data • Idiopathic Pulmonary Fibrosis • Lumbar Back Pain • Multiple Sclerosis • Osteoarthritis • Pain

Contineum Therapeutics Reports First-Quarter 2025 Financial Results... (Businesswire) - "Research and development expenses were $13.7 million, a 76 percent increase from the first quarter of 2024, largely due to higher clinical development expenses related to the advancement of the Company’s PIPE-791 and PIPE-307 programs and higher employee-related costs. The Company continues to believe its full-year 2025 research and development expenses will be significantly higher when compared to the full-year 2024 due to a meaningful increase in clinical development activity across its pipeline."

Commercial • Idiopathic Pulmonary Fibrosis • Multiple Sclerosis • Pain

Contineum Therapeutics Reports...Affirms Key Clinical Development Milestones (Businesswire) - "Contineum expects topline data from its PIPE-791 Phase 1b PET trial in the second quarter of 2025...Contineum plans to initiate Phase 2 proof-of-concept clinical trials in IPF and PrMS in the second half of 2025...The Company anticipates topline data from its PIPE-791 Phase 1b chronic pain trial in early 2026...Contineum expects topline data from its PIPE-307 Phase 2 VISTA RRMS trial in the second half of 2025...The Company plans to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for CTX-343 in the second half of 2025."

Clinical data • IND • New P2 trial • Idiopathic Pulmonary Fibrosis • Multiple Sclerosis • Pain

Contineum Therapeutics Initiates Patient Dosing in Phase 1b Chronic Pain Trial of PIPE-791 (Businesswire) - "Contineum Therapeutics...initiated patient dosing in its exploratory PIPE-791 Phase 1b, randomized, double-blind, placebo-controlled, crossover, chronic pain trial....PIPE-791 is being evaluated for the treatment of chronic pain associated with two separate indications, osteoarthritis (OA) and low back pain (LBP). The Company expects to enroll approximately 40 patients at up to five sites in the U.S., and a treatment duration of 28 days. Contineum anticipates topline data from the PIPE-791 Phase 1b chronic pain trial in early 2026."

P1 data • Trial status • Back Pain • Osteoarthritis • Pain

CTX-791-103: Study of PIPE-791 for Subjects with Chronic Osteoarthritis Pain or Chronic Low Back Pain (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Contineum Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Back Pain • Immunology • Lumbar Back Pain • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

Study of PIPE-791 for Subjects with Chronic Osteoarthritis Pain or Chronic Low Back Pain (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Contineum Therapeutics

New P1 trial • Back Pain • Immunology • Lumbar Back Pain • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

CTX-791-102: PET Study of PIPE-791 in Healthy Volunteers and Volunteers With PrMS and IPF (clinicaltrials.gov) - P1 | N=28 | Recruiting | Sponsor: Contineum Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Idiopathic Pulmonary Fibrosis • Immunology • Multiple Sclerosis • Pulmonary Disease • Respiratory Diseases

Contineum Therapeutics Initiates Patient Dosing in Phase 1b Positron Emission Tomography (PET) Trial of PIPE-791 (Businesswire) - "Contineum Therapeutics...announced dosing of the first cohort of patients in the PIPE-791 Phase 1b positron emission tomography (PET) trial. PIPE-791 is a novel, brain penetrant, small molecule antagonist of the lysophosphatidic acid 1 receptor (LPA1R). The Phase 1b, open label, single-center trial is expected to measure the correlation of pharmacokinetics to receptor occupancy by PET imaging in healthy volunteers, as well as idiopathic pulmonary fibrosis (IPF) and progressive multiple sclerosis (PrMS) patients. Contineum anticipates topline data from the PIPE-791 Phase 1b PET trial in the second quarter of 2025."

P1 data • Trial status • Idiopathic Pulmonary Fibrosis • Multiple Sclerosis

Contineum Therapeutics Expands Clinical Development of PIPE-791 With FDA Authorization of Its Investigational New Drug (IND) Application for Chronic Pain (Businesswire) - "Contineum Therapeutics, Inc...announced authorization of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for PIPE-791 for the treatment of chronic pain associated with two separate indications, osteoarthritis (OA) and low back pain (LBP). PIPE-791 is a novel, brain penetrant, small molecule antagonist of the lysophosphatidic acid 1 receptor (LPA1R). The exploratory Phase 1b, randomized, double-blind, placebo-controlled, crossover, multi-center study is expected to begin in the first quarter of 2025. The Company expects to enroll approximately 40 patients at up to five sites, and a treatment duration of 28 days. Contineum anticipates topline data from the PIPE-791 Phase 1b chronic pain study in early 2026."

IND • New P1 trial • P1 data • CNS Disorders • Pain

PET Study of PIPE-791 in Healthy Volunteers and Volunteers With PrMS and IPF (clinicaltrials.gov) - P1 | N=28 | Not yet recruiting | Sponsor: Contineum Therapeutics

New P1 trial • CNS Disorders • Idiopathic Pulmonary Fibrosis • Immunology • Multiple Sclerosis • Pulmonary Disease • Respiratory Diseases

Contineum Therapeutics Reports Third Quarter 2024 Financial Results and Recent Business Highlights (Businesswire) - "In September 2024, Contineum submitted a Clinical Trial Authorization (CTA) to the Medicines and Healthcare projects Regulatory Agency (MHRA) to commence a Phase 1b open-label clinical trial of PIPE-791 to measure the relationship of pharmacokinetics to receptor occupancy by PET imaging in healthy volunteers, as well as progressive multiple sclerosis and idiopathic pulmonary fibrosis (IPF) patients. Assuming near-term MHRA authorization of Contineum’s CTA submission, Contineum plans to enroll the first two healthy volunteers in this trial in December 2024 and to have the full dataset from this trial in the first half of 2025."

New P1 trial • CNS Disorders • Idiopathic Pulmonary Fibrosis • Immunology • Inflammation • Multiple Sclerosis • Pulmonary Disease

Third Quarter 2024 Financial Results (Businesswire) - "Research and development expenses were $9.7 million for the three months ended September 30, 2024, compared to $6.5 million for the three months ended September 30, 2023. The increase of $3.2 million from period to period was primarily due to a $1.1 million increase in contract research organization costs primarily related to our on-going VISTA Phase 2 clinical trial for PIPE-307 for the potential treatment of RRMS, a $1.5 million increase in expenses for toxicology studies primarily for PIPE-791, a $0.6 million increase in personnel-related expense, and a $0.7 million increase in stock-based compensation. Partially offsetting these increases was a $0.7 million decrease in manufacturing expenses for PIPE-791."

Commercial • CNS Disorders • Idiopathic Pulmonary Fibrosis • Immunology • Inflammation • Multiple Sclerosis • Pulmonary Disease

Contineum Therapeutics Reports Second Quarter 2024 Financial Results and Recent Business Highlights (Businesswire) - "Research and Development Expenses. Research and development expenses were $7.9 million for the three months ended June 30, 2024, compared to $9.5 million for the three months ended June 30, 2023. The decrease of $1.6 million for the three months ended June 30, 2024, compared to the three months ended June 30, 2023 was primarily driven by a $4.8 million decrease in consulting and manufacturing expenses which were offset by increases in expenses related to our on-going Phase 2 clinical trial for PIPE-307 for RRMS and our completed Phase 1 healthy volunteer clinical study for PIPE-791, expenses for toxicology studies for PIPE-791 and personnel related costs."

Commercial • Idiopathic Pulmonary Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease

Lysophosphatidic Acid Receptor Subtype-1 Antagonist PIPE-791 Reduces Neuropathic Pain in Macaques (IASP 2024) - "Based on suppression of brain regions mediating pain intensity and pain affect in a nonhuman primate model of peripheral neuropathy, the current neuroimaging findings support the notion that LPAR1 block leads to antinociception. The current findings also suggest blocking neuroinflammation as a novel mechanism of reducing neuropathic pain. Further studies are needed to assess whether suppression of peripheral or central LPAR1 is crucial for antinociceptive efficacy."

Anesthesia • Inflammation • Neuralgia • Pain • Peripheral Neuropathic Pain

Contineum Therapeutics Reports First Quarter 2024 Financial Results and Recent Business Highlights (Businesswire) - P1 | N=56 | NCT05983939 | Sponsor: Contineum Therapeutics | "Significantly Extended Cash Runway Through the Completion of the Company’s Initial Public Offering. In April 2024, Contineum completed its initial public offering (IPO) resulting in net proceeds of $108.0 million, providing the Company with sufficient capital to generate multiple readouts from PIPE-791 studies in idiopathic pulmonary fibrosis (IPF) and progressive multiple sclerosis (MS) and PIPE-307 studies in depression and RRMS....Met Primary and Secondary Objectives in PIPE-791 Phase 1 Clinical Trial....PIPE-791 was well-tolerated across all four single ascending dose and three multiple ascending dose cohorts. Contineum expects to initiate a Phase 1b open-label trial of PIPE-791 in the fourth quarter of 2024 to establish the relationship of PK to lung and brain receptor occupancy by PET imaging."

Commercial • P1 data • Idiopathic Pulmonary Fibrosis • Immunology

Discovery of a brain penetrant small molecule antagonist targeting LPA1 receptors to reduce neuroinflammation and promote remyelination in multiple sclerosis. (PubMed, Sci Rep) - "Direct dosing of PIPE-791 in vivo increased oligodendrocyte number, and in the mouse experimental autoimmune encephalomyelitis (EAE) model of MS, we observed that PIPE-791 promoted myelination, reduced neuroinflammation, and restored visual evoked potential latencies (VEP). These findings support targeting LPA1 for remyelination and encourage development of PIPE-791 for treating MS patients with advantages not seen with current immunosuppressive disease modifying therapies."

Journal • CNS Disorders • Immunology • Inflammation • Multiple Sclerosis • Solid Tumor

Study Evaluating Safety and Tolerability of Escalating Single and Multiple Doses of PIPE-791 and Food Effect in Healthy Volunteers (clinicaltrials.gov) - P1 | N=56 | Completed | Sponsor: Contineum Therapeutics | Recruiting ➔ Completed | N=80 ➔ 56

Enrollment change • Trial completion • CNS Disorders • Multiple Sclerosis

Study Evaluating Safety and Tolerability of Escalating Single and Multiple Doses of PIPE-791 and Food Effect in Healthy Volunteers (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Pipeline Therapeutics, Inc.

New P1 trial • CNS Disorders • Multiple Sclerosis

Pipeline Therapeutics Receives IND Clearance from FDA to Initiate Phase 1 Study of PIPE-791 (Businesswire) - "Pipeline Therapeutics...announced that the U.S. Food and Drug Administration (FDA) cleared the company to initiate its Phase 1 clinical trial of PIPE-791 in healthy volunteers...'We expect to commence dosing in the second half of 2023'...The Phase 1 clinical trial of PIPE-791 will be conducted as a randomized, double-blind, placebo-controlled dose-ranging study, and enroll approximately 80 healthy volunteer subjects."

IND • New P1 trial • CNS Disorders • Multiple Sclerosis

PIPE-791, a potent brain-penetrant selective LPA1 antagonist, reduces neuroinflammation in vivo (Neuroscience 2022) - "PIPE-791 is a promising therapeutic for multiple sclerosis as it not only promotes remyelination, but also reduces neuroinflammation in vivo. As such, PIPE-791 shows promise for many CNS dysfunctions caused by neuroinflammation."

Preclinical • CNS Disorders

Discovery of remyelination therapeutics that overcome the effects of inflammatory macrophages on oligodendrocyte formation (Neuroscience 2022) - "Both are promising therapeutics to promote remyelination in people with Multiple Sclerosis. PIPE-307 is currently advancing in phase 2 clinical trials while PIPE-791 is entering IND enabling toxicity studies."

CNS Disorders