📋 Cara Therapeutics (CARA) - Clinical Trial Update
Filing Date: 2026-01-16
Accepted: 2026-01-16 06:04:33
Event Type: Clinical Trial Update
Event Details:
Cara Therapeutics (CARA) Announces Clinical Trial Update
Cara Therapeutics (CARA) provided an update on its clinical development programs.
Clinical Development Highlights:
Drug Program: approvals, contained
Clinical Stage: clinical trial
Targeting STAT3: Central Mediator of Fibrosis-Driven Diseases Deep expertise in STAT3 biology Potential to serve as a disease-modifying therapy TTI-109: designed to enhance delivery of STAT3 inhibitor & improve tolerability Multiple near-term data catalysts expected • Unlocking highly-validated target within fibrosis-driven diseases • Demonstrated target engagement and disease modification across animal models of proliferative disease • Demonstrated enhanced biological activity in fibrotic cancers in P1 • Observed reductions in fibrosis and inflammation marker (IL-6) in IPF1 P2 • Evaluating mono- and combination therapy in fibrosis-driven HCC2 P2 • TTI-109 P1 healthy volunteer data in 1H:2026
expected in 1H:2026
expected in this patient populationTreatment emergent adverse event: any adverse event that emerges after treatment with TTI-101 or placebo. Safety analysis performed on all patients treated with at least one dose of TTI-101. 2No instances of drug-induced liver injury reported across visits or treatment groups. All increases in investigations (labs) were transient. 13 Treatment-Emergent Adverse Events Resulting in Discontinuations by Concomitant Nintedanib Use Dose Placebo (n=29) TTI-101 400mg/day (n=30) TTI-101 800mg/day (n=29) Reason for discontinuation by concomitant nintedanib use Nintedanib (n=17) Placebo (n=12) TTI-101 + Nintedanib (n=18) TTI-101 alone (n=12) TTI-101 + Nintedanib (n=16) TTI-101 alone (n=13) Gastrointestinal disorders 2 4 7 4 Investigations (Labs)2 4 4 2 Respiratory, thoracic and mediastinal disorders 1 3 2 1 2 Majority of discontinuations were observed with concomitant nintedanibAdverse events selected to align with INPULSIS categories; safety analysis performed on all patients treated with at least one dose of TTI-101. Certain data on this slide are based on cross-study comparisons and are not based on any head-to-head clinical trials. Cross-study comparisons are inherently limited and may suggest misleading similarities and differences. The values shown in the cross-study comparisons are directional and may not be directly comparable. 1Richeldi et al. NEJM, 2014
🔬 Clinical Development Pipeline (Cara Therapeutics):
Product
Type
Development Stage
Therapeutic Area
Source
nula-cel Drug Product
GENETIC
Phase PHASE1
Sickle Cell Disease
ClinicalTrials.gov
CHR-2797 (tosedostat): Aminopeptidase inhibitor
DRUG
Phase PHASE1
Acute Myeloid Leukemia
ClinicalTrials.gov
MA09-hRPE Cellular Therapy
BIOLOGICAL
Phase PHASE1
Myopic Macular Degeneration
ClinicalTrials.gov
Placebo
DRUG
Phase PHASE2
Hypertriglyceridemia
ClinicalTrials.gov
MAR001
DRUG
Phase PHASE2
Hypertriglyceridemia
ClinicalTrials.gov
STR-P004 dose group
DRUG
Approved
Autoimmune Diseases
ClinicalTrials.gov
Pembrolizumab (KEYTRUDA®)
DRUG
Phase PHASE2
Metastatic Head and Neck Squamous Cell Carcinoma
ClinicalTrials.gov
Ficerafusp alfa
DRUG
Phase PHASE2
Metastatic Head and Neck Squamous Cell Carcinoma
ClinicalTrials.gov
CP-383
DRUG
Phase PHASE1
Solid Tumor Malignancies
ClinicalTrials.gov
ART5803
DRUG
Phase PHASE1
Autoimmune Encephalitis
ClinicalTrials.gov
MAR002
DRUG
Phase PHASE1
Acromegaly
ClinicalTrials.gov
Dexpramipexole Dihydrochloride
DRUG
Phase PHASE3
Eosinophilic Asthma
ClinicalTrials.gov
STR-P004
DRUG
Approved
Acute Lymphobkastic Leukemia
ClinicalTrials.gov
Intravenous (IV) single dose
DRUG
Phase PHASE1
Prostate Cancer
ClinicalTrials.gov
CBX-12
DRUG
Phase PHASE2
Platinum-resistant Ovarian Cancer
ClinicalTrials.gov
phenylacetate salt of ornithine
OTHER
Approved
Healthy
ClinicalTrials.gov
Intravenous immunoglobulin (IVIG)
DRUG
Phase PHASE1
Autoimmune Encephalitis Caused by N-Methyl D-Aspartate Receptor Antibody
📋 Cara Therapeutics (CARA) - Clinical Trial Update
Filing Date: 2026-01-16
Accepted: 2026-01-16 06:04:33
Event Type: Clinical Trial Update
Event Details:
🔬 Clinical Development Pipeline (Cara Therapeutics):
💼 Business Developments:
Structured Data: