Contineum Therapeutics Reports Positive Topline Data From Its Exploratory PIPE-791 Phase 1b Trial in Chronic Pain

• The trial achieved its primary endpoint demonstrating favorable safety and tolerability

• Encouraging trends observed across multiple exploratory efficacy endpoints including improvements in measures of pain and other functional patient-reported outcomes

• Results support further evaluation of PIPE-791 for the potential treatment of chronic pain

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 reported positive topline data from its exploratory Phase 1b trial of PIPE-791, a potentially best-in-class selective antagonist of the lysophosphatidic acid 1 (LPA1) receptor, for the non-opioid treatment of chronic osteoarthritis pain (COAP) or chronic low back pain (CLBP).

“These results demonstrate that PIPE-791, administered as a once-daily 10mg oral dose, was well tolerated in the largest patient population and longest treatment duration studied to date, reinforcing our confidence in its profile and its potential relevance to the PROPEL-IPF trial,” said Timothy Watkins, M.D., M.Sc., Chief Medical Officer and Head of Development, Contineum Therapeutics. “We are pleased with these results, which showed consistent trends toward improvement across multiple exploratory efficacy endpoints evaluating chronic pain that, in general, numerically outperformed placebo. These endpoints included measures of average daily pain, worst daily pain and the proportion of patients demonstrating a 30% or greater reduction in pain from baseline. We believe these findings, particularly the COAP data, provide evidence of preliminary efficacy that support further evaluation of PIPE-791 for the potential treatment of chronic pain, and we are contemplating next steps for further clinical development.”

Clinical Trial Overview

The randomized, double-blind, placebo-controlled, 4-week, crossover trial enrolled 43 patients (23 COAP and 20 CLBP). The trial design incorporated a washout period for patients prior to the first 4-week treatment period (TP1), after which patients crossed over immediately into a second 4-week treatment period (TP2) without an intervening PIPE-791 washout. PIPE-791 was administered orally at 10mg once-daily. More information on this trial can be found at https://clinicaltrials.gov (NCT06810245).

Safety and Tolerability

The trial met its primary objective of assessing safety and tolerability, demonstrating an adverse event (AE) profile generally consistent with previous PIPE-791 clinical trials. Most treatment-emergent adverse events (TEAEs) were mild to moderate, with no serious AEs reported. The most common TEAEs were headache (n=3) and fatigue (n=2). No clinically meaningful changes in mean systolic or diastolic blood pressure or clinically-relevant orthostatic events were observed.

Exploratory Efficacy Results

Pain intensity was assessed using the 11-point Pain-Intensity Numerical Rating Scale (PI-NRS). The PI-NRS was analyzed as the change from baseline in weekly average of average daily pain. Patients treated with PIPE-791 generally demonstrated improvements from baseline in pain that were numerically greater than the placebo arm. Similar trends were observed when PI-NRS was evaluated as the weekly average of the worst level of daily pain.

Weekly Average of Average Daily PI-NRS Scores and Changes to End of Treatment

COAP

CLBP

Treatment Period 1

PIPE-791 (N=11)

Placebo (N=11)

PIPE-791 (N=10)

Placebo (N=10)

Baseline Weekly Average PI-NRS*

5.58 (1.21)

6.23 (1.43)

5.60 (1.27)

5.57 (1.50)

Change from Baseline (95% CI)†

-1.60 (-2.49, -0.72)

-1.27 (-2.15, -0.39)

-1.33 (-1.83, -0.84)

-0.55 (-1.33, 0.22)

Treatment Period 2

PIPE-791 (N=11)

Placebo (N=10)

PIPE-791 (N=9)

Placebo (N=10)

Baseline Weekly Average PI-NRS*

4.96 (2.21)

3.56 (1.45)

4.72 (1.89)

4.75 (1.81)

Change from Baseline (95% CI)†

-1.42 (-2.28, -0.56)

-0.74 (-1.83, 0.35)

0.13 (-0.68, 0.94)

-0.55 (-2.38, 1.29)

• Reported as Mean (standard deviation - SD) of the daily average PI-NRS scores for the 7 days preceding randomization (Treatment Period 1) or Week 5 (Treatment Period 2), respectively. † Reported as the Mean change from Baseline in the weekly average of the daily average PI-NRS scores, 95% Confidence Interval (CI), to the end of Treatment Period 1 (Week 4) or the end of Treatment Period 2 (Week 8), respectively.

In addition to the average measures of PI-NRS, exploratory efficacy endpoints included an assessment of clinical responders (30% ≥ reduction from baseline in PI-NRS) and the Modified Knee Injury and Osteoarthritis Outcome Scale (KOOS). Results from these exploratory measures further supported the positive PI-NRS findings.

Dr. Robert H. Dworkin, Professor of Anesthesiology and Perioperative Medicine and of Neurology at University of Rochester Medicine, added, “Chronic pain remains a very significant unmet medical need, particularly for patients seeking effective and safe non-opioid treatment options. The early signals observed with PIPE-791, including improvements in pain measures and responder rates, are encouraging. The novel LPA1 activity targets underlying mechanisms of pain. These data provide compelling support for further clinical investigation.”

PIPE-791 For the Treatment of Chronic Pain

Chronic pain is often associated with neuropathic symptoms caused by aberrant signaling in the central nervous system (CNS). LPA1 activation has been shown preclinically to contribute to persistent hypersensitivity through demyelination of nerve fibers, increased neuronal excitability and neuroinflammation. By selectively blocking LPA1, PIPE-791 has the potential to modulate the maladaptive changes in the CNS and reduce pain.

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.

Contacts

Steve Kunszabo Contineum Therapeutics Senior Director, Investor Relations & Corporate Communications 858-649-1158 [email protected]