Feldan Therapeutics Announces the treatment of the first patient in the Phase 1/2a clinical trial of its candidate FLD-103, against basal cell carcinoma

QUEBEC CITY and SYDNEY, Oct. 31, 2024 /CNW/ - Feldan Therapeutics (Feldan), a biopharmaceutical company specializing in the development of treatments based on intracellular delivery of therapeutics, has announced its first patient being dosed in Phase 1/2a clinical study of Lead development candidate FLD-103; an intralesional injection intended to provide an alternative to surgery to patients diagnosed with basal cell carcinoma (BCC).

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

The trial design is supported by in vivo pharmacology studies conducted with FLD-103, in various models, which demonstrated that FLD-103 is effective in reducing tumour growth following intralesional injection. The results of toxicology studies have also shown that FLD-103 was well tolerated following repeated intravenous or intradermal daily dosing for up to 28 days.

BCC, the most common skin cancer and the most widespread form of all cancers affects 3.6 million people each year in Canada and the United States. It is characterized by the development of tumours, primarily in sun-exposed skin areas, such as the face, neck, and scalp. With the promise of minimizing side effects, avoiding scarring, and eliminating the need for postoperative recovery compared to surgery, FLD-103 has the potential to become a minimally invasive first-line option for patients with BCC and significantly improve their quality of life. Additionally, FLD-103 could reduce the time to treatment by addressing the long pre-surgery delays and being available to primary care dermatologists.

"I am very enthusiastic about this study and FLD-103's potential to address a critical unmet need in the treatment of basal cell carcinoma," 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 seeing how FLD-103 progresses and how it will transform patient care in the years to come."

"The entry into clinical trials marks a proud moment for Feldan," said François-Thomas Michaud, co-founder, and CEO of Feldan. "This milestone highlights 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

The standard treatment for BCC is surgical removal or excision. While non-surgical treatments exist, they are not indicated for all types of BCC and often show limited efficacy. As a result, many patients must undergo surgery, facing significant preoperative anxiety, psychological distress, and lengthy recovery periods. Mohs surgery is a commonly used technique that involves cutting away layers of skin until there is no evidence of cancer. This procedure frequently results in wounds that can take months or even years to heal and can leave permanent scars on visible areas of the body. Additionally, patients with BCC are at a higher risk of developing new or multiple lesions, requiring repeated surgeries.

FLD-103 is an efficient, non-surgical approach to treat BCC. This first-in-class non-invasive intralesional treatment selectively targets BCC cells by disrupting an intracellular component involved in the pathophysiology of the disease. By minimizing side effects, avoiding scarring, and the need for postoperative recovery, FLD-103 has the potential to become a minimally invasive first-line option and life-changing treatment for patients suffering from BCC.  

ABOUT FELDAN THERAPEUTICS

Located in Quebec City, Canada, Feldan is a biopharmaceutical company pioneering the development of treatments based on the intracellular delivery of therapeutics. Feldan has designed the Feldan Shuttle, a proprietary, peptide-based technology that enables the safe and efficient delivery of various compounds inside cells. This technology unlocks the development of a new generation of therapies by giving access to intracellular targets beyond the reach of existing drugs. Feldan's pipeline currently focuses on diseases affecting the skin and lungs.

For more information: www.feldan.com & LinkedIn

SOURCE Feldan Therapeutics

Stéphanie Levesque, Director - Corporate Governance & Communications, 418.872.7277, [email protected]