AMP-303 injectable treatment for androgenetic alopecia: A multicenter, randomized, placebo-controlled feasibility study of a novel polysaccharide

Summary: Background: AMP-303 is a proprietary novel polysaccharide designed for intradermal injection and developed to stimulate scalp hair growth in patients with Androgenetic Alopecia. Methods: In this randomized, within-subject controlled, double-blind, multicenter study, male subjects aged 18-45 with mild to moderate androgenetic alopecia (Group 1 (n=32): duration 3-5 years; Group 2 (n=29): ≥10 years) received AMP-303 injections on 1 side of the scalp and saline injections on the contralateral side. Treatments were administered to the frontotemporal scalp, with 2 mL injected on each side in ~20 locations spaced 0.5 cm apart. Hair count was analyzed from digital images for a representative 1 cm2 target area on each side of the scalp through 5 months. Results: The 61 subjects were fairly evenly divided among the 3 targeted classifications of alopecia (modified Norwood Hamilton III, III vertex, and IV). AMP-303 demonstrated a trend in increased non-vellus hair count. For the Group 1 responders, the mean percent increase in nonvellus hair count peaked at 60 days (14.5%) for AMP-303 and was significantly greater than saline through 5 months (p<0.005). AMP-303 showed durability of effect with 1 injection cycle and indicates hair terminalization. Local skin reactions (most commonly edema) were similar between AMP-303 and saline, with most being of minimal or mild severity and resolving by the 14-day visit. The most common treatment-related adverse events were mild headache (7.8%) and mild skin swelling (bilateral 3.1% and AMP-303 side 1.6%), and almost all adverse events resolved during the study period. Conclusion: AMP-303 was safe and well-tolerated and demonstrated a trend in increased nonvellus hair for males with mild to moderate androgenetic alopecia. Further studies are warranted to explore the effects of repeat cycle administration of AMP-303 on scalp hair growth. Jeremy B. Green⁴, John H. Joseph³, Janet C. DuBois², William R. Rassman², Frank Fazio¹, Maksim V. Plikus¹, Wajdie Ahmad¹ 1. Amplifica Holdings group, Inc, San Diego, CA, United States. 2. DermResearch, Austin, TX, United States. 3. Clinical Testing of Beverly Hills, Encino, CA, United States. 4. Skin Associates of South Florida, Coral Gables, FL, United States. Clinical Research: Interventional Research