Combining Gli1 Transcription Factor Targeting and the Feldan Shuttle Delivery Platform

Feldan Therapeutics is conducting a Phase 1/2a clinical trial to evaluate the safety and efficacy of FLD-103, an innovative drug candidate for the treatment of Basal Cell Carcinoma (BCC). FLD-103 is a first-in-class, topical treatment that combines FSD147L, a cell-penetrating peptide, with a morpholino oligomer (PMO-Gli1) that inhibits a key transcription factor in the Hedgehog signaling pathway. This drug utilizes the Feldan Shuttle, a proprietary intracellular delivery platform, designed to penetrate cell membranes and directly reach target mRNA. By overcoming intracellular delivery barriers, it fundamentally inhibits the expression of genes that cause basal cell carcinoma, which has been difficult for existing treatments to access, and is attracting attention in the industry.

A Non-Surgical, Local Injection Treatment Strategy that Overcomes the Limitations of Existing Treatments

Currently, the standard of care for basal cell carcinoma is Mohs micrographic surgery or surgical excision. However, when the cancer occurs in visible areas such as the face, it can cause significant scarring and cosmetic side effects. Oral Hedgehog pathway inhibitors such as Erivedge (vismodegib) and Odomzo (sonidegib) are available, but they have high rates of discontinuation due to severe systemic toxicities such as loss of taste and hair loss. FLD-103 is being developed as a topical injection that is administered directly to the tumor, minimizing systemic toxicity and selectively removing the lesion, offering a non-surgical alternative. This is expected to address the significant unmet need in elderly patients or those with comorbidities who are not suitable for surgery.

Phase 1/2a Trial Design and Safety Evaluation through Multiple Ascending Dose (MAD)

This Phase 1/2a trial, conducted in Australia, employs a Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) design, focusing on establishing a safe dosage range. The trial will involve more than 18 patients and will evaluate the drug's tolerability and pharmacokinetic (PK) profile at various concentrations, including 0.5 mg/mL, 1.0 mg/mL, and 3.0 mg/mL. Patients will receive weekly injections directly into the lesion for four weeks, during which time the minimization of blood flow into the lesion after local administration will be closely monitored. This comprehensive data collection will serve as a crucial stepping stone for future efficacy evaluations and the determination of the optimal Phase 2 dose (RP2D).

A $3 Billion Basal Cell Carcinoma Market and Accelerated Pipeline through Investment

The global basal cell carcinoma treatment market is estimated at approximately $3.5 billion (USD) in 2026 and is projected to grow to over $8 billion by 2035 due to the aging population and increased exposure to ultraviolet radiation. Based on this growth potential, Feldan Therapeutics successfully completed a $21 million (USD) Series B funding round in September 2024, led by Genesys Capital. These funds will be strategically invested to accelerate the clinical development of FLD-103 and to gain a favorable position in discussions for licensing agreements with global pharmaceutical companies. If positive preliminary safety and tumor reduction efficacy data are obtained in this trial, the company's value and platform value are expected to increase significantly.