Feldan Therapeutics Begins Phase 1/2a Clinical Trial for Basal Cell Carcinoma Treatment

QUEBEC CITY and SYDNEY, October 31, 2024 –

Feldan Therapeutics (Feldan), a biopharmaceutical company specializing in intracellular drug delivery, announced today the dosing of the first patient in its Phase 1/2a clinical study for FLD-103, a groundbreaking intralesional injection treatment for basal cell carcinoma (BCC).

Pioneering a Minimally Invasive Approach to BCC Treatment

This multi-center, first-in-human study will evaluate the safety, tolerability, and efficacy of FLD-103 in patients diagnosed with BCC. The trial is expected to enroll approximately 70 adult patients who will receive treatment for a maximum of 28 days. The design includes an open-label, single and multiple ascending dose escalation phase followed by a placebo-controlled dose expansion.

The trial is based on promising in vivo pharmacology studies using FLD-103 in various models, demonstrating its effectiveness in reducing tumor growth after intralesional injection. Toxicology studies have also shown excellent tolerability of FLD-103 following repeated intravenous or intradermal daily dosing for up to 28 days.

Addressing a Significant Need

BCC is the most common cancer worldwide, affecting millions annually. It primarily presents on sun-exposed skin areas, causing significant distress and impacting patients’ quality of life. While surgical removal is the standard treatment, it often leads to scarring, lengthy recovery periods, and psychological stress. By offering a minimally invasive alternative with minimal side effects, FLD-103 has the potential to revolutionize BCC treatment.

Positive Outlook from Experts

“I am extremely enthusiastic about this study and FLD-103’s potential to address this critical unmet need in BCC treatment,” said Dr. Juliana Junger, Dermatologist and Principal Investigator of the study. “By offering a more patient-focused approach without compromising efficacy, this intralesional therapy could represent a major shift in the way we approach BCC. I look forward to witnessing FLD-103’s progress and its transformative impact on patient care in the years to come.”

Feldan’s Commitment to Innovation

“Reaching this clinical trial milestone marks a significant accomplishment for Feldan,” said François-Thomas Michaud, Co-Founder and CEO of Feldan. “This achievement underscores our team’s dedication and expertise, advances our mission to deliver breakthrough treatments, and strengthens our leadership in intracellular drug delivery. We remain committed to exploring innovative therapies that prioritize patients’ outcomes and quality of life.”

About FLD-103

FLD-103 stands out as a revolutionary, non-surgical approach to treat BCC. This first-in-class intralesional treatment targets BCC cells directly, minimizing side effects associated with traditional surgery. By offering a minimally invasive, more patient-centric treatment option, FLD-103 has the potential to significantly improve the lives of individuals affected by BCC.

About Feldan Therapeutics

Based in Quebec City, Canada, Feldan Therapeutics is a leading biopharmaceutical company specializing in intracellular drug delivery. Feldan has developed the proprietary Feldan Shuttle technology, a peptide-based platform that enables the safe and efficient delivery of therapeutic agents inside cells. This groundbreaking technology opens new avenues for developing treatments for a range of diseases, particularly those affecting the skin and lungs.