Contineum Therapeutics Touts PIPE-791 IPF Focus as Pain Data Hint at Wider Potential

Key Points

• Contineum remains focused on PIPE-791 for idiopathic pulmonary fibrosis (IPF), saying the drug’s main value is in pulmonary fibrosis even as the company evaluates whether it could also help patients with chronic pain.
• A small Phase 1b pain study in osteoarthritis and chronic lower back pain met its primary safety and tolerability endpoint, with exploratory results showing numerical pain improvements and a stronger signal in osteoarthritis, though management cautioned against overinterpreting the crossover data.
• CEO Carmine Stengone said PIPE-791’s safety profile has been “very benign” so far, with no meaningful blood pressure or cardiac issues observed, which could differentiate it from Bristol Myers Squibb’s LPA1 program and support further IPF development.

Contineum Therapeutics NASDAQ: CTNM President and Chief Executive Officer Carmine Stengone said the company remains focused on advancing PIPE-791 in idiopathic pulmonary fibrosis, while recent exploratory pain data may point to additional clinical opportunities for the LPA1 receptor antagonist.

Speaking in a session hosted by RBC Capital Markets analyst Nevin Varghese, Stengone discussed a small exploratory Phase 1b study of PIPE-791 in chronic osteoarthritic pain and chronic lower back pain. He said the study enrolled patients across the two pain syndromes, with safety and tolerability as the primary endpoint and exploratory measures including PI-NRS pain scores, responder rates and patient-reported outcomes tied to activities of daily living in osteoarthritis.

Stengone said the trial met its primary safety and tolerability endpoint, while adding that the company believes the safety findings help de-risk its ongoing Phase 2 study in idiopathic pulmonary fibrosis, or IPF.

PIPE-791 Pain Signals Seen as Centrally Mediated

Asked whether the observed pain improvements were tied to central activity of PIPE-791, Stengone said the company is “pretty confident” the effect involved central activity, while also noting potential peripheral and central mechanisms.

He said Contineum has also evaluated a peripherally restricted LPA1 receptor antagonist in animal models and observed an “outsized response” with a centrally active compound. Stengone described PIPE-791 as having a unique profile, saying Contineum is the only company he is aware of with a centrally active LPA1 receptor antagonist.

Stengone cautioned against overinterpreting the pain findings. The trial used a crossover design with four weeks on drug followed by crossover to placebo, or vice versa, without a washout period. He said the company is looking closely at the first treatment period because it is more similar to a potential parallel-design Phase 2 study.

According to Stengone, numerical improvements were seen in both chronic lower back pain and osteoarthritis, but the osteoarthritis signal was “objectively better.” He said osteoarthritis is a more homogeneous condition, while chronic lower back pain includes a more varied patient population, including musculoskeletal pain, joint pain, sciatica and lumbar spinal stenosis.

Safety Profile Highlighted as IPF Study Continues

Stengone said the Phase 1b pain study represented the longest dosing exposure for PIPE-791 so far, with patients treated for four weeks at the highest dose tested in the company’s multiple-ascending-dose study in healthy volunteers.

He described the adverse event profile as “very benign,” generally mild to moderate. Stengone emphasized that Contineum monitored blood pressure during the study and did not observe hemodynamic effects, major adverse events or cardiac issues.

The comments came in the context of comparisons with Bristol Myers Squibb’s LPA1 program. Stengone said BMS has been open about a hypotension signal across its studies and appears to have used dose titration in Phase 3 to address it. While he said he would “never say never,” Stengone added that the data so far raise Contineum’s confidence that PIPE-791 will not show the same blood pressure issues.

IPF Remains the Primary Focus

Stengone said the “lion’s share” of Contineum’s value and current clinical focus is in IPF and pulmonary fibrosis. However, he said the pain data warrant further clinical study, and the company is reviewing the results, speaking with key opinion leaders and engaging with pharma companies and investors before deciding on next steps.

He said the company is not considering acute pain indications for PIPE-791 because of the drug’s pharmacokinetics. Osteoarthritis currently looks stronger than chronic lower back pain, he said, but Contineum is also considering whether PIPE-791 could improve quality of life for patients with pulmonary fibrosis who experience chronic pain.

Stengone said current IPF treatments slow the decline in forced vital capacity, or FVC, but do not necessarily make patients feel better day to day. He said Contineum hopes PIPE-791 could potentially improve lung function while adding a quality-of-life benefit, including possible relief of thoracic or knee pain.

Potential Differentiation Versus Bristol Myers Squibb

Looking ahead to expected data from Bristol Myers Squibb’s admilparant in IPF, Stengone said Contineum expects the drug may work in IPF and progressive pulmonary fibrosis, though that remains to be seen. He said Contineum is focused on running a robust, well-controlled Phase 2 trial because two well-controlled studies are a key component of approval.

Stengone listed several potential differentiators for PIPE-791, including once-daily dosing, lack of clinically relevant blood pressure issues seen to date, extended coverage above 90% receptor occupancy and the possible quality-of-life benefit suggested by the pain study.

He said the broader pulmonary fibrosis treatment landscape is entering a “renaissance,” pointing to newer therapies such as nerandomilast and TYVASO. Stengone said additional drugs are positive for patients, but he also noted challenges such as gastrointestinal effects, drug-drug interaction considerations and dosing burden in the current treatment landscape.

Contineum is currently focused on IPF, but Stengone said the company is confident in the potential for LPA1 receptor antagonism in progressive pulmonary fibrosis. He said Contineum could run a Phase 3 study in IPF and, in parallel, a Phase 3 study in PPF.

PIPE-307, Partnerships and Cash Runway

Stengone also discussed PIPE-307, which is being studied for major depressive disorder by partner Johnson & Johnson. He said the biological rationale in depression differs from multiple sclerosis, involving M1 receptor antagonism on inhibitory GABA neurons, increased glutamate burst and a synaptogenic response.

J&J has updated its ClinicalTrials.gov listing for the depression study, Stengone said, with study conclusion expected in June and data anticipated in the second half of the year.

On PIPE-307 in multiple sclerosis, Stengone said Contineum ran a well-controlled study in which the drug was safe and tolerable, but missed its primary endpoint. He said there may be questions about whether the endpoint, low contrast letter acuity, was ideal, and added that exploratory work has produced “interesting nuggets” for J&J.

Stengone said Contineum does not foresee partnering PIPE-791, its lead asset, in the near future, though the company may consider partnerships for earlier-stage assets. He said PIPE-791 has patent coverage through 2042, with potential patent term extensions pushing coverage to 2044.

Contineum recently reported about $250 million in cash, Stengone said, which the company expects to fund operations through the middle of 2029 and provide a buffer beyond the conclusion of its Phase 2 PROPEL-IPF study.

About Contineum Therapeutics NASDAQ: CTNM

Contineum Therapeutics, Inc, a clinical stage biopharmaceutical company, focuses on discovering and developing novel oral small molecule therapies for neuroscience, inflammation, and immunology indications with high unmet need. Its lead asset is PIPE-791, a novel, brain penetrant, small molecule inhibitor of the lysophosphatidic acid 1 receptor (LPA1R) for the treatment of idiopathic pulmonary fibrosis and progressive multiple sclerosis (MS). The company also develops PIPE-307, a novel, small molecule selective inhibitor of the muscarinic type 1 M1 receptor to treat depression and relapse remitting MS; and CTX-343, a peripherally-restricted LPA1R antagonist.

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