WOODLAND HILLS, California, USA, May 16, 2024 – Angitia Biopharmaceuticals, a global, clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for serious musculoskeletal diseases, today announced positive top-line results from its first in human (FIH) study of AGA2118. The study, entitled “A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Doses Study to Evaluate the Safety, Tolerability, Absolute Bioavailability, Pharmacokinetics, and Pharmacodynamics of AGA2118 in Men and Postmenopausal Women”, demonstrates an excellent safety and tolerability profile, as well as preliminary efficacy in increasing bone mineral density (BMD) after single and multiple dose administrations.

AGA2118 is a first-in-class bispecific antibody developed by Angitia. This FIH study of AGA2118 demonstrated a favorable safety profile with rapid increase in bone formation and simultaneous decrease in bone resorption, leading to a robust increase in BMD at the lumbar spine, total hip, and femoral neck. The results of these clinical assessments indicate that AGA2118 has the potential to be a safe and effective treatment for postmenopausal osteoporosis and male osteoporosis, and warrants further evaluation in randomized, controlled clinical trials.

Dr. Willard H. Dere, M.D., Chief Medical Officer of Angitia, commented, “The top-line results of the AGA2118 Phase I study demonstrate the potential of AGA2118 for the treatment of osteoporotic patients at high risk of fragility fractures and other conditions associated with low bone mass and poor bone structure. These encouraging data provide strong evidence to support continuing clinical development of AGA2118. We plan to present the detailed clinical results at future scientific meetings. Angitia is looking forward to working with regulatory agencies around the globe and advancing this exciting drug candidate to help patients worldwide.”

About Osteoporosis

Osteoporosis is defined as a systemic skeletal disease characterized by low bone mass and microarchitectural deterioration of bone tissue, with a consequent increase in bone fragility and susceptibility to fracture. Osteoporosis has become a global epidemic, especially for older women, due to an aging population and longer life expectancies. Estimates indicate that more than 200 million patients worldwide suffer from osteoporosis.

Although there are a number of approved therapies for osteoporosis, limitations remain regarding the efficacy and/or safety of each of these options. Research also indicates that the majority of severely osteoporotic individuals do not receive a bone-active agent. As a result, a large unmet medical need remains for the development of new osteoporosis therapies.

About AGA2118

AGA2118 is a bispecific antibody developed and wholly-owned by Angitia. AGA2118 targets two critical factors involved in bone metabolism, aiming to improve the duration and magnitude of BMD gain in osteoporosis. AGA2118 is being studied for clinical development in osteoporosis.

About Angitia Biopharmaceuticals

Angitia Biopharmaceuticals is a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for serious musculoskeletal diseases. Leveraging the team's extensive experience and scientific acumen in novel drug development, Angitia is committed to providing groundbreaking therapies to satisfy key unmet medical needs.

Learn more at www.angitiabio.com.

Investor & Media Contact:

William Windham
Solebury Strategic Communications
wwindham@soleburystrat.com
646-378-2946

Forward-Looking Statement 

This press release is prepared by Angitia (the “Company", “We”) for informational purposes only. Forward-looking statements include all statements that are not historical facts and, in some cases, can be identified by terms such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “continue,” “could,” “potential,” “may,” “will,” “goal” or similar expressions and the negatives of those terms. However, not all forward-looking statements contain these identifying words. 

These forward-looking statements are based on the current projects, expectations, assumptions, and understandings of the Company with respect to future events as of the date these statements are made. These statements are not a guarantee or warranty of future developments or otherwise.  

These statements involve substantial known and unknown risks, uncertainties, and other factors that are beyond the Company’s control and are difficult to predict and may cause our actual results, timing of results, or achievements to be materially different from the information expressed or implied by these forward-looking statements. We anticipate that subsequent events and developments may cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. 

Except as expressly required by law, the Company and/or its officers, directors, employees, and agents shall not assume responsibility for the accuracy and completeness of the forward-looking statements in the information provided.