Union 7

Our Pipeline

Stage
Clinical
Candidate
Modality & Indication
Phase1/Phase 2
Phase 3
NDA Filing
Candidate
TH104

MOR/KOR

TH023

Anti-TNFα

Modality & Indication

Buccal Transmucosal Film

Temporary prophylaxis of respiratory and/or nervous system depression in military personnel and chemical incident responders entering an area contaminated with high-potency opioids

Phase1/Phase 2
NDA Fileable
No further clinical trials necessary†
Modality & Indication

Moderate-to-Severe Chronic Pruritus in PBC

Status: Phase 1

Phase 2
Ready*

Phase 2
Ready*

TH023

Anti-TNFα

Modality & Indication

Oral Infliximab

Standard-of-care approved as IV/SC

Multiple high-value autoimmune indications

Phase 1
Plan**

Phase 3
NDA Filing

Phase 1
Plan**

Anticipated Milestones
Anticipated Milestones
2025:

CMC Plan Completion

2025/2026:

Stability Data Completion

2026:

File NDA

2026:

HI Study Initiation*

2025:

CMC Optimization
Ph 1 Planning

  • MOR = mu opioid receptor; KOR = kappa opioid receptor; TNFα = tumor necrosis factor-alpha;
  • *Phase 2 Clinical CMC completed; HI – hepatic impairment; TH104 is Phase 2 ready in the EU and US with FDA and EMA feedback received
  • **trial initiation ex-US; Celltrion has right-of-first refusal post clinical study
  • †Tharimmune recently received positive feedback from the FDA regarding a regulatory pathway that will allow the Company to submit a 505(b)(2) New Drug Application (NDA) for TH104. Importantly, the FDA has confirmed that no additional clinical trials will be required prior to NDA submission for this indication.

Lead Program: TH104

TH104 is an innovative pharmaceutical represents a cornerstone in our science and clinical program. TH104 employs a novel approach by encapsulating the drug onto a proprietary transmucosal buccal film, adhering seamlessly to the mouth’s inner lining.
With the completion of our Phase 1 trial, we engaged and received positive feedback from the FDA regarding the additional proposed indication of temporary prophylaxis of respiratory and/or nervous system depression in military personnel and chemical incident responders entering and area contaminated with high-potency opioids. The Company received positive feedback from the FDA regarding a regulatory pathway that will allow Tharimmune to submit a 505(b)(2) New Drug Application (NDA) for TH104. The FDA confirmed that no additional clinical trials will be required prior to NDA submission for this indication, which will be the lead program for the Company.
Tharimmune is a clinical-stage biotechnology company developing a diverse portfolio of therapeutic candidates in immunology, inflammation and oncology. Its lead clinical asset, TH104, is being developed for a specific indication via a 505(b)2 pathway for respiratory and/or nervous system depression in military personnel and chemical incident responders who may encounter environments contaminated with high-potency opioids. The expanded pipeline includes other indications for TH104, such as chronic pruritus in primary biliary cholangitis and TH023, a new approach to treating autoimmune diseases along with an early-stage multispecific biologic platform targeting unique epitopes against multiple solid tumors through its proprietary EpiClick™ Technology.

More Information

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