Amplifica Announces First-in-Human Study Initiated

Amplifica's AMP-303 safety and tolerability study targeting hair loss

SAN DIEGO, June 28, 2023 /PRNewswire/ -- Amplifica Holdings Group, Inc. ("Amplifica"), a privately held, clinical-stage biopharmaceutical company announced the initiation of the first-in-human study of its lead candidate AMP-303. The primary objective of this initial study is to evaluate the safety and tolerability of AMP-303 along with an assessment on hair count in subjects with androgenetic alopecia. The trial marks a significant milestone in the development of innovative solutions to address the widespread issue of hair loss, which affects millions of men and women worldwide.

"The initiation of our first-in-human clinical study represents a major advancement in our commitment to delivering innovative treatments for hair loss," commented Frank Fazio, President and CEO. "Aside from assessing AMP-303 in subjects with androgenetic alopecia, this study will serve as a strong foundation for subsequent clinical studies with Amplifica's pipeline compounds."

The study is a multicenter, randomized, double blinded and placebo-controlled study that will enroll male subjects across three groups: subjects with recent onset of hair loss (defined as a history of hair loss of ~3 to 5 years), subjects with established hair loss (defined as a history of hair loss > 10 years); and subjects who have undergone a hair transplant procedure. The first subject was dosed on June 27, 2023 and the study is expected to be completed in first quarter of 2024.

"We are excited to embark on this landmark clinical trial program and collaborate with leading medical professionals to assess the potential of AMP-303," added Wajdie Ahmad, Amplifica's Executive Chairman. "The data generated from this study will provide crucial insights into Amplifica's development programs."

Amplifica is at the forefront of revolutionizing the field of hair restoration and is committed to adhering to the highest ethical and scientific standards throughout the clinical study program, Participants interested in joining the initial clinical program in the Los Angeles, California or Coral Gables, Florida areas can submit their interest on the company's website at amplificabio.com/#contact-us.

About Amplifica Holdings Group, Inc.

Amplifica is a rapidly emerging biopharmaceutical company focused on developing novel treatments to address androgenic alopecia (hair loss), a condition estimated to affect over 50 million men and over 30 million women in the United States alone. The Company is taking a nature-inspired scientific approach using a molecular mechanism that regrows natural hair. The Company has identified and isolated unique signaling molecules that stimulate hair follicles to regrow hair. Amplifica will be initiating clinical trials to evaluate the safety and efficacy of its core technology as well as obtaining all applicable regulatory approvals.

For more information, please visit https://amplificabio.com.

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SOURCE Amplifica