AMP-303 Study by Amplifica Reveals New Hope for Hair Loss Treatments

Promising Results from First-in-Human Trial for Androgenetic Alopecia Treatment

SAN DIEGO, Sept. 30, 2024 — Amplifica Holdings Group Inc. ("Amplifica"), a clinical-stage biopharmaceutical company, has announced impressive outcomes from its initial human trial of AMP-303, an innovative intradermal injection designed to treat androgenetic alopecia (AGA), the most prevalent type of hair loss. This randomized, double-blind, placebo-controlled, multicenter study aimed to assess the safety and tolerability of AMP-303, as well as its effectiveness. Findings from the study indicate that AMP-303 has significant potential to combat hair loss after just one treatment cycle.

Participants in the trial were males aged 18 to 45 diagnosed with AGA. Subjects were grouped based on the duration of their hair loss: either recent (3-5 years) or long-term (over 10 years). Each participant received AMP-303 on one side of their scalp and a placebo on the other, facilitating a direct comparison. This bilateral paired treatment design, alongside subject stratification, allowed for a thorough analysis of AMP-303's efficacy across different stages of hair loss while minimizing individual variability.

Study Highlights:

1. **Safety Profile**: AMP-303 was found to be safe and well-tolerated. Most adverse events were mild, and there were no severe adverse events. Local skin reactions to the injections were similar between AMP-303 and placebo, consistent with other intradermal injections.

2. **Efficacy**: A significant percentage of participants (P <0.001) experienced over a 15% increase in non-vellus hair count from baseline compared to placebo at 60 days post-treatment, and over a 10% increase at 150 days post-treatment.

3. **Durable Results**: A single treatment cycle of AMP-303 not only increased non-vellus hair count but also maintained hair density and thickness over 150 days post-treatment, showing substantial improvement over placebo.

4. **Hair Terminalization**: The treatment also demonstrated an ability to convert vellus hairs into non-vellus hairs, highlighting its potential to reverse hair loss.

Frank Fazio, President and CEO of Amplifica, noted, "The ability to show significant hair regrowth with just one treatment cycle is a breakthrough in the fight against androgenetic alopecia. These results validate our approach and pave the way for advancing other programs in Amplifica's pipeline. We are eager to accelerate the development of new therapies targeting hair regeneration, reinforcing our commitment to novel treatments for androgenetic alopecia."

William Rassman, MD, co-founder of Amplifica and a pioneer in hair restoration surgery, added, "The results in the frontal temporal region are particularly promising, as this area has been challenging to treat clinically. AMP-303's potential to stimulate hair regrowth in this region sets it apart from existing therapies and offers new hope for patients who have been resistant to treatment in the past."

With the promising results from this initial study, Amplifica plans to advance AMP-303 through further clinical trials to explore its therapeutic potential for both men and women suffering from hair loss. The company aims to develop AMP-303 as a differentiated option in the hair loss treatment landscape, which currently relies on daily-use topical and oral therapies.

About AMP-303:
AMP-303 is a proprietary intradermal injectable formulation engineered to target AGA. It has undergone extensive pre-clinical development, including mechanism of action studies and proof-of-concept testing in xenograft models, showing significant hair growth-promoting properties. The treatment is backed by a robust intellectual property portfolio, underscoring its potential as a groundbreaking solution for AGA sufferers.

About Amplifica Holdings Group, Inc.:
Amplifica is an emerging biopharmaceutical company dedicated to developing novel treatments for androgenetic alopecia, a condition affecting over 50 million men and 30 million women in the U.S. Employing a nature-inspired scientific approach, Amplifica has isolated unique signaling molecules that stimulate hair follicles to regrow hair. The company is initiating product development programs and clinical trials to evaluate the efficacy and safety of its core technology, aiming to secure all necessary regulatory approvals.