Excaliard Pharmaceuticals is a San Diego-based biopharmaceutical company developing novel drugs for the treatment of skin fibrosis, more commonly referred to as skin scarring. The Company recently completed three Phase 2 trials with its lead product, EXC 001. Results from all three studies have demonstrated statistically significant reductions in scar severity compared to placebo. EXC 001 was also well tolerated with no important drug related adverse effects observed. Currently, there are no FDA-approved products to reduce scar severity, and the Company believes that EXC 001 is well positioned to be at the forefront of this multi-billion dollar market opportunity.
Key Features
- Significant Efficacy Seen in Phase 2 Studies: The Company has completed three Phase 2 clinical studies in a range of scar-forming surgical procedures; a fine-line model pannus procedure, a study in patients undergoing elective abdominoplasty (“tummy tuck”), and a study in women undergoing elective revision of hypertrophic scars of the breast. Each study was conducted as a double blind, multi-center, within patient placebo controlled trial, with endpoints up to 6 months (see press release).
- Effectiveness Observed in a Wide Range of Scar Severity: Results from the Phase 2 studies demonstrated that efficacy was seen in scars ranging from fine-line to hypertrophic, providing evidence that EXC 001 may have utility in a wide range of scar types and surgical procedures.
- Excellent Safety Profile: EXC 001 has been studied in over 200 subjects in both Phase 1 and Phase 2 clinical trials and EXC 001 was well tolerated with no important drug related adverse effects observed.
- Large Market Opportunity: In the U.S., there are more than 5 million relevant cosmetic and reconstructive surgery procedures performed each year, along with over 90 million other surgical procedures, providing a very substantial unmet clinical need for the reduction of scar severity following surgery or traumatic injury.
Business Development
Excaliard has successfully completed three Phase 2 trials in elective surgical procedures. These studies demonstrated the efficacy and safety of EXC 001 in elective revision surgery of scars resulting from prior breast surgery, in fine line scars in elective abdominoplasty surgery and in a biomarker study of abdominal scarring.
For information about business development opportunities at Excaliard Pharmaceuticals please contact business.development@excaliard.com