First-in-human trial demonstrates promising results for treatment of male pattern baldness
SAN DIEGO , Sept. 30, 2024 /PRNewswire/ — Amplifica Holdings Group Inc. (“Amplifica”), a privately held clinical-stage biopharmaceutical company, today announced results from its first human clinical trial for AMP-303. did. A new intradermal injection treatment for androgenetic alopecia (AGA), the most common hair loss condition. This randomized, double-blind, placebo-controlled, multicenter study was designed to evaluate the safety and tolerability of AMP-303, as well as its efficacy. This result suggests that AMP-303 has great potential to address hair loss after one treatment cycle.
The study enrolled male participants between the ages of 18 and 45 with a diagnosis of AGA and stratified them based on duration of hair loss. In this study, participants were divided into two different groups. One group had recently started hair loss (3 to 5 years) and the other group had had hair loss for a longer period of time (more than 10 years). A bilateral paired treatment design in the frontotemporal region was used, with each participant randomized to receive AMP-303 on one side of the scalp and placebo on the other side, allowing for direct within-individual comparisons. is now possible. This approach, combined with stratification of subjects by onset of hair loss, allowed analysis of the potential efficacy of AMP-303 across different time points and stages of hair loss while controlling for individual differences.
Main research results:
Safety Profile: AMP-303 was observed to be safe and well-tolerated. The majority of adverse events were mild, and no serious adverse events were reported. Local skin reactions to intradermal injections were similar between AMP-303 and placebo and consistent with other intradermal injections. Efficacy: A statistically significant proportion of study subjects (P < 0.001) demonstrated greater than a 15% increase in non-vellus hair count from baseline compared to placebo at 60 days after treatment, and at 60 days after treatment. The eye showed an increase of more than 10% compared to placebo. 150 days after treatment. Durable results: In this study, one treatment cycle of AMP-303 increased the number of non-vellus hairs and maintained hair density and thickness over time (150 days post-treatment), compared to placebo. It was found that there was a significant improvement in comparison. Hair termination: The study results also demonstrated AMP-303's ability to stimulate the transition from vellus to non-vellus hair, further highlighting the potential of treatments to reverse hair loss.
“Being able to demonstrate visible improvements in hair regrowth in just one treatment cycle represents a breakthrough in the fight against male pattern baldness,” said Frank Fazio, President and CEO of Amplifica. It’s progress.” “The success of the AMP-303 study not only validates our approach, but also establishes the foundation for driving additional programs in Amplifica’s pipeline. Building on this momentum, we We are excited to accelerate the development of new treatments targeting the regeneration of male pattern baldness and strengthen our efforts to develop new treatments to address male pattern baldness. ”
“The results observed in the frontotemporal region are particularly encouraging, as this region has traditionally been associated with clinical response,” said William Rathman, MD, hair restoration surgery pioneer and co-founder of Amplifica. AMP is one of the most difficult areas to demonstrate. -303’s potential to stimulate hair regeneration in this area highlights its unique potential, and the results of this early clinical study offer new hope for patients suffering from hair loss that have so far been resistant to treatment. brings. ”
Following the results of this first-in-human study, Amplifica will continue to develop AMP-303 through additional clinical trials to further explore its therapeutic potential for both men and women suffering from hair loss. We are poised to move forward. The company aims to develop AMP-303 as a highly differentiated option in the hair loss treatment field, which is currently limited to topical and oral therapies for daily use.
About AMP-303
AMP-303 is a unique and innovative formulation specifically designed for intradermal injection to target androgenetic alopecia (AGA). AMP-303, designed to stimulate hair regeneration, has undergone extensive preclinical development, including detailed identification and understanding of its mechanism of action. Proof-of-concept testing in xenograft models demonstrated its potent hair growth-promoting properties and laid the foundation for its potential as an innovative treatment. Complementing this scientific advancement is a robust intellectual property portfolio, ensuring the innovation behind AMP-303 and reinforcing its promise as a breakthrough solution for individuals suffering from AGA.
About Amplifica Holdings Group, Inc.
Amplifica is focused on developing new treatments to address androgenic alopecia (hair loss), which is estimated to affect more than 50 million men and 30 million women in the United States alone. A rapidly growing biopharmaceutical company. We use a nature-inspired scientific approach that utilizes the molecular mechanisms that regenerate natural hair. The company has identified and isolated a unique signaling molecule that stimulates hair follicles to regrow hair. Amplifica will begin a product development program and clinical trials to evaluate the safety and efficacy of its core technology and obtain all applicable regulatory approvals.
For more information, please visit https://amplificabio.com.
Forward-looking statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “expects”, “believes” and similar words. , “contemplate”, “could”, “estimate”, “expect”, “intend”, “seek”, “may”, “could”, “plan”, “could” “is,” “anticipates,” “plans,” “target,” “target,” “should,” “will,” “will” or the negation of these words, or other similar words. expression. These forward-looking statements are based on our current beliefs and expectations. Forward-looking statements include, but are not limited to, statements regarding the potential effectiveness of our product candidates, our expectations regarding the development and commercialization of our product candidates, and the initiation or completion of future clinical trials. but not limited to. Actual results may differ from the forward-looking statements made by the Company in this press release, and these forward-looking statements should not be relied upon as predictions of future events. The forward-looking statements contained in this announcement are made as of the date hereof, and we undertake no obligation to update such information except as required by applicable law.
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SOURCE Amplifica Holdings Group, Inc.
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