CX-4945 in Viral Community Acquired Pneumonia

NCT06202521 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: CX-4945-011
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 7

Brief Summary

This is a Phase II, multi-center, double-blind, randomized, interventional study in approximately 120 subjects to evaluate clinical benefit of CX-4945 in adult outpatients with SARS-CoV-2 and influenza viral infection-associated pneumonia. The subjects will be recruited into two domains, including SARS-CoV-2 and influenza virus domains. The study will compare the efficacy of Standard of Care (SOC) combined with CX-4945 against SOC paired with a placebo, utilizing a 1:1 allocation ratio in each domain.

Conditions

Community-acquired Pneumonia; SARS-CoV-2 -Associated Pneumonia; Influenza With Pneumonia

Keywords

Covid-19; Influenza; Community-acquired Pneumonia

Outcome Measures

Primary Outcomes (1)

• The Percentage of Subjects Requiring Hospitalization, Including Emergency Room Visits, or Resulting in Death Due to Progression of CAP Related to SARS-CoV-2 or Influenza.

  To evaluate the effect of intervention with Silmitasertib (CX-4945) in addition to SOC, compared to placebo plus SOC, in preventing the progression of CAP associated with SARS-CoV-2 and influenza virus infection

  Day 1 to Day 29

Secondary Outcomes (6)

• The Percentage of Subjects With All Cause Hospitalization, Emergency Room Visits, or Death During Study Period.

  Day 1 to Day 29

• The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy

  Baseline to Day 5/7

• The Symptom Resolution for Fever is Defined as Body Temperature Lower Than the Following Definition for 24 Hours (Ear Temperature < 38 °C, Base of the Tongue Temperature < 37.5 °C, or Axillary Temperature < 37 °C)

  Day 1 to Day 5/7

• Change From Baseline in SpO2/FiO2 Ratio

  Day 1 to Day 5/7, 15, and 29

• The Percentage of Subjects Exhibiting Disease Progression in Health Status Disease Progression is Defined as an Increase of Score on the National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale

  Day 1 to Day 5/7, 15, and 29

Study Arms (4)

SARS-CoV-2 domain: CX-4945 (400 mg BID for 5 days) +SOC

EXPERIMENTAL

Notes: The SOC within the SARS-CoV-2 domain is defined as the medications in use at each respective site for the treatment of CAP related to SARS-CoV-2 infection.

Drug: CX-4945 (SARS-CoV-2 domain)

SARS-CoV-2 domain: Placebo + SOC

PLACEBO COMPARATOR

Notes: The SOC within the SARS-CoV-2 domain is defined as the medications in use at each respective site for the treatment of CAP related to SARS-CoV-2 infection.

Drug: Placebo (SARS-CoV-2 domain)

Influenza virus domain: CX-4945 (400 mg BID for 5 days) +SOC

EXPERIMENTAL

Notes: The SOC within the influenza virus domain is defined as the medications in use at each respective site for the treatment of CAP related to influenza virus infection.

Drug: CX-4945 (Influenza virus domain)

Influenza virus domain: Placebo + SOC

PLACEBO COMPARATOR

Notes: The SOC within the influenza virus domain is defined as the medications in use at each respective site for the treatment of CAP related to influenza virus infection.

Drug: Placebo (Influenza virus domain)

Interventions

CX-4945 (SARS-CoV-2 domain) DRUG

CX-4945 will be administered at 400 mg BID for up to 5 days (Day 1 to Day 5) in addition to SOC.

Also known as: Silmitasertib

SARS-CoV-2 domain: CX-4945 (400 mg BID for 5 days) +SOC

Placebo (SARS-CoV-2 domain) DRUG

The dosage and frequency is the same as active drug.

SARS-CoV-2 domain: Placebo + SOC

CX-4945 (Influenza virus domain) DRUG

CX-4945 will be administered at 400 mg BID for up to 5 days (Day 1 to Day 5) in addition to SOC.

Also known as: Silmitasertib

Influenza virus domain: CX-4945 (400 mg BID for 5 days) +SOC

Placebo (Influenza virus domain) DRUG

The dosage and frequency is the same as active drug.

Influenza virus domain: Placebo + SOC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Not currently hospitalized
• Males or females aged ≥ 18 years at the time of signing the informed consent form (ICF)
• Patients diagnosed with viral pneumonia, as determined by the investigator, who exhibit any of the subsequent criteria: presence of respiratory symptoms or fever (ear temperature ≥ 38 °C, base of the tongue temperature ≥ 37.5 °C, or axillary temperature ≥ 37 °C)
• With a pneumonia severity index (PSI) of risk class II or III
• Oxygen saturation measured by pulse oximetry (SpO2) ≥ 94% on room air at sea level
• Positive test for SARS-CoV-2 or influenza virus infection, confirmed by rapid diagnostic test (excluding cases where both SARS-CoV-2 and influenza virus are positive)
• Confirmed lower respiratory tract infection by X-ray
• At screening, subjects capable of childbearing must provide a negative serum or urine pregnancy test. These subjects must also commit to adhering to the study-specified contraceptive methods throughout the study duration
• Notes: Acceptable contraceptive methods include:
• Established use of oral, injected or implanted hormonal methods of contraception
• Placement of an intrauterine device (IUD) or intrauterine system (IUS)
• Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps)
• The participant (or legal representative) agrees and is able to adhere to study protocol-stated requirements, instructions, and restrictions in the investigator's judgement. Furthermore, the participant is capable of understanding and has signed the IRB-approved Informed Consent Form (ICF)
• With at least two of the risk factors listed below: Age ≥ 50 years-old; cancer and a life expectancy of ≥ 6 months; HIV infection; immunocompromised patient; congestive heart failure (CHF), or coronary artery disease (CAD), or cardiomyopathies; chronic kidney disease (CKD); chronic liver disease; chronic lung disease; diabetes mellitus (DM); body mass index (BMI) \> 25 kg/m2; asthma; cerebrovascular disease; cystic fibrosis; dementia; or current and former smoker

You may not qualify if:

• Subject received investigational treatment within 30 days prior to the study, or concurrent use of another investigational drug
• Subject has a history of severe renal disease (required phosphate binders or dialysis)
• Subject has chronic diarrhea, characterized by three or more loose stools daily for a minimum of four weeks
• High likelihood of mortality within the next 48 hours, as assessed by the investigator
• Subject showing signs of respiratory failure and mechanical ventilation is required
• Subject with liver cirrhosis
• Subject with hepatitis B and/or hepatitis C disease, unless the subject has an aspartate aminotransferase (AST) level ranging from 8 to 31 U/L and an alanine aminotransferase (ALT) level from 0 to 41 U/L
• Known active tuberculosis
• Current documented bacterial infection
• Subject has a documented anaphylactic reaction, regardless of cause
• Subject who has taken an antiviral agent against respiratory viral infection for a continuous duration of more than 24 hours before screening
• Subject is with active gastrointestinal diseases including gastritis, ulcerative colitis, Crohn's disease, or hemorrhagic coloproctitis
• Subjects received warfarin within 14 days prior to screening or intend to during the screening or treatment phase
• History of allergic reactions to any of the ingredients or components used in the manufacture of CX-4945
• Women who are pregnant or breastfeeding, or planning pregnancy during the study

Sponsors & Collaborators

• Senhwa Biosciences, Inc.: lead

Study Sites (7)

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Location

Far Eastern Memorial Hospital

New Taipei City, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

National Taiwan University Cancer Center, National Taiwan University Hospital

Taipei, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Tri-Service General Hospital

Taipei, Taiwan

Location

Taoyuan General Hospital, Ministry of Health and Welfare

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia; COVID-19; Influenza, Human

Interventions

silmitasertib

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Orthomyxoviridae Infections

Limitations and Caveats

This trial was terminated early on March 31, 2025 due to insufficient differentiation of the primary endpoint in addressing the unmet medical need, as well as recruitment difficulties caused by the end of the flu season.

Results Point of Contact

• Title: Becky Lin, Project Manager of Clinical Department
• Organization: Senhwa Biosciences

beckylin@senhwabio.com

+886-2-8911-9856

Study Officials

• Jason Huang, M.D.

  Senhwa Biosciences

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2024
• First Posted: January 11, 2024
• Study Start: March 20, 2024
• Primary Completion: April 22, 2025
• Study Completion: April 22, 2025
• Last Updated: January 8, 2026
• Results First Posted: January 8, 2026

Record last verified: 2025-12

Locations

TW (7)