PRODUCT PIPELINE
advancing innovative exosome-based therapies
for Inflammation
INTENT Biologics is committed to developing novel regenerative exosome biologics that address significant unmet medical needs. Our pipeline is specifically designed to treat topical and subdermal chronic wounds, areas where traditional therapies often fall short.
PEP Biologic™ (Purified Exosome Product)
A Platform Biotechnology
Our flagship product candidate, PEP Biologic™, is a first-in-class topical biologic harnessing the regenerative power of platelet-derived exosomes. Clinically validated and strategically positioned for multiple indications, PEP Biologic™ represents a transformative approach in treating severe wounds.
Key Features:
- Topical biologic with polyvalent regenerative action.
- Sustained, targeted delivery at the site of injury or inflammation.
- Highly scalable, proprietary manufacturing process (developed by RION).
- Demonstrated superior efficacy compared to current standard-of-care treatments.
Advanced Tissue Regeneration Pipeline
Our advanced wound care program leverages compelling clinical and compassionate-use data to rapidly advance toward regulatory approval across multiple indications:
| Indication | Phase 1 | Phase 1b | Phase 2 | Phase 3 | Commercialized |
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| Diabetic Foot Ulcers (DFU) | |||||
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Unmet Need: Only 24% heal at 12 weeks with standard care
U.S. Market Size: $6.0B | |||||
| Radiation Ulcers (CRU) | |||||
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Unmet Need: Near 0% heal with current treatments
U.S. Market Size: $0.5 Billion | |||||
| Pressure Ulcers | |||||
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Unmet Need: ~50% heal at 12 weeks with standard care
U.S. Market Size: $5.4 Billion | |||||
| Surgical Wounds | |||||
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Unmet Need: 85% heal within 1 year with standard care
U.S. Market Size: $1.0 Billion | |||||
| Venous Leg Ulcers (VLU) | |||||
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Unmet Need: 30–60% heal within 24 weeks with standard care
U.S. Market Size: $5.3 Billion | |||||
U.S. Market Size: $6.0B
U.S. Market Size: $0.5 Billion
U.S. Market Size: $5.4 Billion
U.S. Market Size: $1.0 Billion
U.S. Market Size: $5.3 Billion
Clinical
Milestones
- Completed successful Phase 2 trial in DFU showing significantly enhanced healing (54% vs. 25% standard care at 12 weeks).
- Compassionate-use successes in chronic wounds previously unresponsive to treatment (radiation ulcers, venous leg ulcers).
- Expanded Access Program (EAP) planned for non-healing chronic wounds (Q3 2025).
Clinical Development Timeline
- 2025
- 2026 - 2027
- 2028
• Initiation of Phase 3 Diabetic Foot Ulcer trial
• Phase 1b/2a Chronic Radiation Ulcer trial (DoD-funded)
• IND filing and initiation of Phase 1b Atopic Dermatitis study
• Expanded Access Program launch for chronic wounds
• Initiation of Phase 3 pivotal trials for Pressure Ulcers, Surgical Wounds, and Venous Leg Ulcers
• Phase 2/3 initiation for Atopic Dermatitis
• Anticipated Biologics License Application (BLA) submission for Diabetic Foot Ulcer indication
• Label expansions into additional chronic wound indications via supplemental filings
• Phase 3 starts planned for psoriasis, vitiligo, SD
Publications
INTENT Biologics remains dedicated to transparency and scientific rigor, reflected in numerous peer-reviewed publications and scientific presentations validating our exosome-based therapeutic approach.