Amplifica’s AMP-303 stimulates hair growth in the frontal temporal region among men with androgenetic alopecia (AGA), according to results from the first-in-human study.
AMP-303 is a novel intradermal injectable treatment for androgenetic alopecia that targets unique signaling molecules that stimulate hair follicles to regrow hair, Amplifica reports.
The trial enrolled males aged 18 to 45 with AGA. The study divided participants into two distinct groups: those with recent onset of hair loss (3-5 years) and those experiencing more long-standing hair loss (over 10 years). A bilateral paired treatment design in the frontal temporal region was used, where each participant was randomized to receive AMP-303 on one side of the scalp and a placebo on the other. This approach, combined with subject stratification by onset of hair loss, allowed for the analysis of AMP-303’s potential effectiveness across different timepoints and stages of hair loss while controlling for individual variability.
AMP-303 was safe and well tolerated. The majority of adverse events were mild in severity and no severe adverse events were reported. Local skin reactions to intradermal injections were similar between AMP-303 and placebo and consistent with other intradermal injections.
A statistically significant percentage of study subjects showed a greater than 15% increase in non-vellus hair count from baseline compared to placebo at 60 days post-treatment, and a greater than 10% increase compared to placebo at 150 days post-treatment.
What’s more, a single AMP-303 treatment cycle increased non-vellus hair count and sustained hair density and thickness over time (150 days post treatment), a marked improvement compared to placebo. The study results also demonstrated AMP-303’s ability to stimulate the transition of vellus hairs into non-vellus hairs.
“The ability to demonstrate measurable improvements in hair regrowth with just one treatment cycle is a breakthrough in addressing androgenetic alopecia,” says Frank Fazio, President and CEO of Amplifica, in a news release. “The success of the AMP-303 study not only validates our approach but also sets the foundation for advancing additional programs in Amplifica’s pipeline. With this momentum, we are excited to accelerate the development of new therapies targeting hair regeneration, reinforcing our commitment of developing novel treatments to address androgenetic alopecia.”
William Rassman, MD, an Amplifica co-founder, adds, “The results observed in the frontal temporal region are particularly encouraging, as this area has traditionally been one of the most challenging to demonstrate a clinical response. AMP-303’s potential to stimulate hair regrowth in this region underscores its unique potential and sets it apart from existing therapies. Findings from this initial clinical study offers renewed hope for patients struggling with hair loss that have historically been resistant to treatment.”
