Adlea (capsaicin) / Arcion, Centrexion Therap - LARVOL DELTA

Combined Datasets for CNTX-4975 Osteoarthritis Knee Pain (OAKP) Phase 3 Trials (OAKP 301 and 304) to Assess Overall Efficacy and Safety of an Intra-articular Injection (IAI) of CNTX-4975-05 (CNTX) in Subjects with Chronic, Moderate-to-severe Osteoarthritis Knee Pain (MSOAKP) (ACR Convergence 2023) - "The separate Phase 3 trials did not meet their primary endpoints, suggesting that each trial by itself was underpowered. Combining the two trials demonstrated statistical separation and clinically meaningful benefit, and safety was acceptable. The safety database satisfies the International Conference on Harmonization (ICH) guideline for safety assessments."

Clinical • P3 data • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

A Randomized, Double-blind, Placebo-controlled, Single Injection, 52-Week Study to Evaluate the Efficacy and Safety of an Intra-articular Injection (IAI) of CNTX-4975-05 (CNTX) in Subjects with Chronic, Moderate-to-severe Osteoarthritis Knee Pain (OAKP) - Study 301 (ACR Convergence 2023) - "The study did not meet the primary endpoint, though analgesic efficacy through Week 26 in CNTX was numerically superior to placebo. Improvement in WOMAC A at 12 weeks was significantly greater for CNTX compared to placebo CNTX safety was acceptable. R."

Clinical • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

A Randomized, Double-blind, Placebo-controlled, Repeat Injection, 52-Week Study to Evaluate the Efficacy and Safety of an Intra-articular Injection (IAI) of CNTX-4975-05 (CNTX) in Subjects with Chronic, Moderate-to-severe Osteoarthritis Knee Pain (MSOAKP) - Study 304 (ACR Convergence 2023) - "This study did not meet the primary endpoint. However, the numeric data suggested greater analgesic efficacy through Week 26 in CNTX compared to placebo. CNTX safety was acceptable."

Clinical • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

A Phase 3 Efficacy and Safety Study of Intra-articular CNTX-4975-05 (Capsaicin) vs Placebo in Subjects With OA Knee Pain (clinicaltrials.gov) - P3 | N=332 | Completed | Sponsor: Centrexion Therapeutics | Active, not recruiting ➔ Completed

Trial completion • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

An Open-label, 8-week Safety, Efficacy, and Assessment of Cooling Methods for Administration of CNTX-4975-05 for Knee OA (clinicaltrials.gov) - P3 | N=854 | Completed | Sponsor: Centrexion Therapeutics | Active, not recruiting ➔ Completed

Trial completion • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

An update on targets for treating osteoarthritis pain: NGF and TRPV1. (PubMed, Curr Treatm Opt Rheumatol) - "c)Targeting the NGF and TRPV1 pathways appear effective for reducing OA pain, but further work is needed to better understand which patients may benefit most from these treatments. The anti-NGF antibody tanezumab and the TRPV1 agonist CNTX-4975 have both received fast-track designation from the FDA for the treatment of OA pain."

Journal • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology • NGF

A Clinical Study to Test Efficacy and Safety of Repeat Doses of CNTX-4975-05 in Patients With Osteoarthritis Knee Pain (clinicaltrials.gov) - P3; N=332; Completed; Sponsor: Centrexion Therapeutics; Active, not recruiting ➔ Completed

Trial completion • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

Centrexion Therapeutics Raises $40.5 Million and Adds Lilly and Exome Asset Management as New Investors (GlobeNewswire) - "Centrexion Therapeutics Corporation...today announced that it has raised $40.5 million of cash....Inclusive of this $40.5 million raise, Centrexion has in excess of $75 million of cash to deploy for the continued in-licensing of drug candidates and development of its portfolio of four clinical-stage drug candidates including: 4975 (TRPV1 agonist) in Phase 3 for knee osteoarthritis pain; 6970 (CCR2 antagonist) in Phase 2a for osteoarthritis pain; 6016 (CB2 agonist) in Phase 1b/2a for diabetic neuropath; 0290 (SSTR4 agonist) in Phase 2a for neuropathic, musculoskeletal and inflammatory pain."

Financing • CNS Disorders • Musculoskeletal Pain • Neuralgia • Osteoarthritis • Pain • Peripheral Neuropathic Pain

A Clinical Study to Test Efficacy and Safety of CNTX-4975-05 in Patients With Osteoarthritis Knee Pain (clinicaltrials.gov) - P3; N=332; Active, not recruiting; Sponsor: Centrexion Therapeutics; Completed ➔ Active, not recruiting; Trial completion date: Nov 2019 ➔ Jun 2021; Trial primary completion date: Nov 2019 ➔ Jun 2021

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

A Study to Compare Five Different Treatment Regimens of CNTX-4975 for Participants With Chronic, Moderate-to-Severe Osteoarthritis Pain (clinicaltrials.gov) - P3; N=857; Active, not recruiting; Sponsor: Centrexion Therapeutics; Trial completion date: Jan 2020 ➔ Jun 2021; Trial primary completion date: Oct 2019 ➔ Jun 2021

Clinical • Trial completion date • Trial primary completion date • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

A Clinical Study to Test Efficacy and Safety of Repeat Doses of CNTX-4975-05 in Patients With Osteoarthritis Knee Pain (clinicaltrials.gov) - P3; N=332; Active, not recruiting; Sponsor: Centrexion Therapeutics; Trial completion date: May 2020 ➔ Jun 2021; Trial primary completion date: May 2020 ➔ Jun 2021

Clinical • Trial completion date • Trial primary completion date • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

[VIRTUAL] DETERMINING OPTIMAL COOLING AND ADMINISTRATION METHODS FOR CNTX-4975 INTRA-ARTICULAR INJECTION IN SUBJECTS WITH MODERATE TO SEVERE OSTEOARTHRITIS KNEE PAIN (EULAR 2020) - P3 | "All cooling regimens for CNTX-4975 IA administration were clinically acceptable and well tolerated, offering feasible options for use in routine practice. Importantly, high levels of clinical response were observed 8 weeks after unilateral or bilateral knee injections for moderate to severe OA knee pain. Primary Combined Endpoint Outcome in the Index Knee, Normalized Scale, by Cooling and Administration Procedure (ANCOVA Model) LS, least squares; SD, standard deviation; SE, standard error."

Clinical • Immunology • Osteoarthritis • Pain • Rheumatology

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 Co-administered With Trimethobenzamide Hydrochloride in Healthy Subjects (clinicaltrials.gov) - P1; N=18; Not yet recruiting; Sponsor: Pfizer

New P1 trial • Biosimilar

Plasma long noncoding RNA expression profile identified by microarray in patients with Crohn's disease. (PubMed) - World J Gastroenterol - "The plasma lncRNAs profiles provide preliminary data for the non-invasive diagnosis of CD and a resource for further specific lncRNA-mRNA pathway exploration."

Journal • Biosimilar • Crohn's Disease • Immunology • Inflammatory Bowel Disease

Polyploidy enhances F1 pollen sterility loci interactions that increase meiosis abnormalities and pollen sterility in autotetraploid rice. (PubMed) - "Moreover, 55 meiosis-related or meiosis-stage-specific genes were associated with IPE in autotetraploid rice, including Os02g0497500, which encodes a DNA repair-recombination protein, and Os02g0490000, which encodes a component of the ubiquitin-proteasome pathway. These results suggest that polyploidy enhances epistatic interactions between alleles of pollen sterility loci, thereby altering the expression profiles of important meiosis-related or meiosis-stage-specific genes, and resulting in high pollen sterility."

Journal • Biosimilar

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 Co-administered With Trimethobenzamide Hydrochloride in Subjects With Idiopathic Parkinson's Disease (clinicaltrials.gov) - P1; N=18; Recruiting; Sponsor: Pfizer; Not yet recruiting -> Recruiting

Enrollment open • Biosimilar • Parkinson's Disease

A Clinical Study to Test Efficacy and Safety of CNTX-4975-05 in Patients With Osteoarthritis Knee Pain (clinicaltrials.gov) - P3; N=332; Completed; Sponsor: Centrexion Therapeutics; Active, not recruiting ➔ Completed; Trial completion date: Feb 2020 ➔ Nov 2019

Clinical • Trial completion • Trial completion date

Randomized, Double-Blind, Placebo-Controlled Trial of Intra-articular CNTX-4975 (trans-capsaicin) for Pain Associated With Osteoarthritis of the Knee. (PubMed, Arthritis Rheumatol) - "In this study, CNTX-4975 provided dose-dependent improvement in knee OA-associated pain. CNTX-4975 1.0 mg produced a significant decrease in knee pain due to osteoarthritis through 24 weeks; CNTX-4975 0.5 mg significantly improved pain at 12 weeks, but the effect was not evident at 24 weeks."

Clinical • Journal

Centrexion Therapeutics Announces Issuance of U.S. Composition of Matter Patent for Lead Pipeline Candidate CNTX-4975 (GlobeNewswire, Centrexion Therapeutics) - "Centrexion Therapeutics Corporation...today announced that the U.S. Patent and Trademark Office has issued a composition of matter patent (Patent No 10,493,047) entitled 'Stable Aqueous Capsaicin Injectable Formulations and Medical Uses Thereof,' which provides coverage for the formulation of capsaicin used in the company’s CNTX-4975 product candidate....Centrexion has completed patient enrollment in all three studies comprising the Phase 3 VICTORY clinical program and expects to report the results of VICTORY-1 and VICTORY-3 in the first quarter of 2020. Centrexion anticipates reporting the results of the second pivotal trial, VICTORY-2, in the third quarter of 2020."

Enrollment closed • P3 data • Patent

Evaluation of Intra-articular CNTX-4975 in Subjects with Painful Bilateral Knee Osteoarthritis: Effects on Pain with Walking and Patient Impression of Change in Pain (ACR-ARHP 2019) - P1b, P2; "Pain in bilateral osteoarthritic knees was rated much or very much improved in 87% of assessments, and >40% of knees were reported pain free at 5–6 weeks post CNTX-4975 injection."

Clinical

Centrexion Therapeutics announces CNTX-4975 data presentations at the 2019 American College of Rheumatology Annual Meeting and the 2019 American Academy of Physical Medicine and Rehabilitation Annual Assembly (GlobeNewswire) - "Centrexion Therapeutics Corporation...today announced it will present posters on CNTX-4975 at the 2019 American College of Rheumatology (ACR) Annual Meeting Conference taking place November 8-13, 2019 in Atlanta, Georgia and at the 2019 American Academy of Physical Medicine and Rehabilitation (AAPM&R) Annual Assembly taking place November 14-17, 2019 in San Antonio, Texas." "

Clinical data

Centrexion Therapeutics Announces Completion of Patient Enrollment in VICTORY-3 Phase 3 Open-Label Clinical Trial of CNTX-4975 in Patients with Moderate-to-Severe Osteoarthritis Knee Pain (GlobeNewswire, Centrexion Therapeutics) - "Centrexion Therapeutics Corporation...today announced completion of patient enrollment in its third Phase 3 trial, VICTORY-3....Topline results from VICTORY-3 are expected to be reported in the first quarter of 2020....'Look forward to reporting on the results of VICTORY-3 and the first pivotal trial VICTORY-1 in Q1 of 2020. In Q3 of next year, we expect to report the results of the second pivotal trial VICTORY-2.'"

Clinical • Clinical data • Enrollment status

CORRECTION - Centrexion Therapeutics (GlobeNewswire, Centrexion Therapeutics) - "BOSTON, Sept 04, 2019 (GLOBE NEWSWIRE) -- In a release issued earlier today by Centrexion Therapeutics Corporation (NASDAQ: CNTX), please note that the headline should read "Centrexion Therapeutics Announces CNTX-4975, CNTX-6970 and CNTX-6016 Data Presentations at PAINWeek 2019 National Conference," as opposed to "Centrexion Therapeutics Announces CNTX-4975, CNTX-0290 and CNTX-6970 Data Presentations at PAINWeek 2019 National Conference." The corrected release follows:. Centrexion Therapeutics Announces CNTX-4975, CNTX-6970 and CNTX-6016 Data Presentations at PAINWeek 2019 National Conference."

Clinical data

A Study to Compare Five Different Treatment Regimens of CNTX-4975 for Participants With Chronic, Moderate-to-Severe Osteoarthritis Pain (clinicaltrials.gov) - P3; N=857; Active, not recruiting; Sponsor: Centrexion Therapeutics; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Bilateral Intra-articular Injection of CNTX-4975 for Management of Painful Osteoarthritis of the Knee: Results at 6 Weeks from an Open-label Trial (AAPMR 2019) - "TEAEs reported after day of injection: insect bite (n=2), hay fever, vasovagal attack, back pain, acid reflux (esophageal), allergic conjunctivitis, and bruise (n=1 each), all mild and deemed unlikely/not related to study treatment. Conclusions : Pain reduction following bilateral intra-articular CNTX-4975 1.0 mg injections into osteoarthritic knees was clinically and statistically significant at 6 weeks."

Clinical