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New Approaches to Treating Infections in Cystic Fibrosis Patients - AR 501 Phase 2 Trial Update

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Aridis Pharmaceuticals (NASDAQ: ARDS) announced participation in a Key Opinion Leader (KOL) event on January 24, 2023, focusing on anti-infective treatments for cystic fibrosis (CF) patients. This event highlights the company's Phase 2a trial of AR-501, an inhaled formulation of gallium citrate aimed at treating chronic lung infections in CF patients. Experts, including Dr. Jane E. Gross and Dr. Noah Lechtzin, will discuss the treatment landscape, with Aridis' CEO and Chief Medical Officer also participating. The event underscores the potential of AR-501 in addressing unmet medical needs in CF.

Positive
  • Participation in KOL event showcasing AR-501's Phase 2a trial.
  • AR-501 targets chronic lung infections, addressing a significant unmet need in CF.
  • Presence of key opinion leaders enhances credibility and visibility for AR-501.
Negative
  • No specific data or results from ongoing Phase 2a trial provided.
  • Dependence on KOL event to generate interest may not ensure market traction.

AR-501 is an inhaled formulation of gallium citrate with broad-spectrum anti-infective activity being developed to treat chronic lung infections in CF patients

Los Gatos, Calif., Jan. 17, 2023 (GLOBE NEWSWIRE) -- Aridis Pharmaceuticals, Inc. (NASDAQ: ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies for treating life-threatening infections, today announced its participation in Key Opinion Leader (KOL) event focusing on the anti-infective treatment landscape in cystic fibrosis (CF) and the Company’s Phase 2a trial of AR-501 in CF patients. AR-501 is an inhaled formulation of gallium citrate with broad-spectrum anti-infective activity being developed to treat chronic lung infections in CF patients. The KOL event will take place on January 24 at 11 a.m. EST.

The virtual event will feature key opinion leaders Jane E. Gross, MD, PhD, and Noah Lechtzin, MD, MHS, FCCP. Dr. Gross is a pediatric pulmonologist at National Jewish Health in Denver, Colorado. Board certified in pediatrics and pediatric pulmonology, Dr. Gross previously served as Affiliate Cystic Fibrosis Center Director at Tripler Army Medical Center and Madigan Army Medical Center and has been instrumental in leading the evaluation of the Mycobacterium abscessus epidemic among CF patients in Hawaii. Dr. Lechtzin is an associate professor of medicine at the Johns Hopkins University School of Medicine. He holds a joint appointment in epidemiology at the Johns Hopkins Bloomberg School of Public Health. His areas of clinical expertise include CF, amyotrophic lateral sclerosis (ALS), adult pulmonary disease and critical care medicine. Dr. Lechtzin serves as director of the Adult Cystic Fibrosis Program.

Carl Byrnes, Managing Director and Senior Research Analyst at Northland Capital Markets will host and moderate the virtual KOL. Aridis’ Chief Medical Officer Hasan Jafri, MD, and CEO Vu Truong, PhD, will also participate in the event.

To register for the KOL, please click https://redchip.zoom.us/webinar/register/WN_WB4K1ES0S1aJzl5ucesN5A.

About Aridis Pharmaceuticals, Inc.

Aridis Pharmaceuticals, Inc. discovers and develops novel anti-infective therapies to treat life-threatening infections, including anti-infectives to be used as add-on treatments to standard-of-care antibiotics.

The Company is advancing multiple clinical stage mAbs targeting bacteria that cause life-threatening infections such as ventilator associated pneumonia (VAP) and hospital acquired pneumonia (HAP), in addition to preclinical stage antiviral mAbs. The use of mAbs as anti-infective treatments represents an innovative therapeutic approach that harnesses the human immune system to fight infections and is designed to overcome the deficiencies associated with the current standard of care which is broad spectrum antibiotics. Such deficiencies include, but are not limited to, increasing drug resistance, short duration of efficacy, disruption of the normal flora of the human microbiome and lack of differentiation among current treatments. The mAb portfolio is complemented by a non-antibiotic novel mechanism small molecule anti-infective candidate being developed to treat lung infections in cystic fibrosis patients. The Company’s pipeline is highlighted below:

Aridis' Pipeline

AR-301 (VAP). AR-301 is a fully human IgG1 mAb targeting gram-positive Staphylococcus aureus (S. aureus) alpha-toxin and is being evaluated in a global Phase 3 superiority clinical study as an adjunctive treatment of S. aureus ventilator associated pneumonia (VAP).

AR-320 (VAP). AR-320 is a fully human IgG1 mAb targeting S. aureus alpha-toxin that is being evaluated in a Phase 3 clinical study as a preventative treatment of S. aureus colonized mechanically ventilated patients who do not yet have VAP.

AR-501 (cystic fibrosis). AR-501 is an inhaled formulation of gallium citrate with broad-spectrum anti-infective activity being developed to treat chronic lung infections in cystic fibrosis (CF) patients. This program is currently in Phase 2a clinical development in CF patients.

AR-701 (COVID-19). AR-701 is a cocktail of fully human mAbs discovered from convalescent COVID-19 patients that are directed at multiple protein epitopes on the SARS-CoV-2 virus. It is formulated for delivery via intramuscular injection or inhalation using a nebulizer.

AR-401 (blood stream infections). AR-401 is a fully human mAb preclinical program aimed at treating infections caused by gram-negative Acinetobacter baumannii.

AR-101 (HAP). AR-101 is a fully human immunoglobulin M, or IgM, mAb in Phase 2 clinical development targeting Pseudomonas aeruginosa (P. aeruginosa) liposaccharides serotype O11, which accounts for approximately 22% of all P. aeruginosa hospital acquired pneumonia cases worldwide.

AR-201 (RSV infection). AR-201 is a fully human IgG1 mAb out-licensed preclinical program aimed at neutralizing diverse clinical isolates of respiratory syncytial virus (RSV).

For additional information on Aridis Pharmaceuticals, please visit https://aridispharma.com/.

Forward-Looking Statements

Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. These statements may be identified by the use of words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Aridis' expectations, strategy, plans or intentions. These forward-looking statements are based on Aridis' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the need for additional financing, the timing of regulatory submissions, Aridis' ability to obtain and maintain regulatory approval of its existing product candidates and any other product candidates it may develop, approvals for clinical trials may be delayed or withheld by regulatory agencies, risks relating to the timing and costs of clinical trials, risks associated with obtaining funding from third parties, management and employee operations and execution risks, loss of key personnel, competition, risks related to market acceptance of products, intellectual property risks, risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm our financial condition and increase our costs and expenses, risks associated with the uncertainty of future financial results, Aridis' ability to attract collaborators and partners and risks associated with Aridis' reliance on third party organizations. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described under the caption "Risk Factors" in Aridis' 10-K for the year ended December 31, 2021 and Aridis' other filings made with the Securities and Exchange Commission. Forward-looking statements included herein are made as of the date hereof, and Aridis does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

Contact:
Media Communications:
Matt Sheldon
RedChip Companies Inc.
Matt@redchip.com
1-917-280-7329

Investor Relations
Dave Gentry
Redchip
Dave@redchip.com
1-800-733-2447 

SOURCE Aridis Pharmaceuticals, Inc.


FAQ

What is AR-501 and its purpose?

AR-501 is an inhaled formulation of gallium citrate being developed by Aridis Pharmaceuticals to treat chronic lung infections in cystic fibrosis patients.

When is the KOL event featuring AR-501?

The KOL event focusing on AR-501 will take place on January 24, 2023, at 11 a.m. EST.

What are the key features of the Phase 2a trial for AR-501?

The Phase 2a trial aims to evaluate AR-501's effectiveness in treating chronic lung infections in cystic fibrosis patients, although specific data has not yet been disclosed.

Who are the key opinion leaders participating in the KOL event?

The KOL event will feature Dr. Jane E. Gross and Dr. Noah Lechtzin, both experts in cystic fibrosis treatment.

What is the expected impact of AR-501 on the market?

If successful, AR-501 could significantly impact the treatment landscape for cystic fibrosis by addressing chronic lung infections that currently lack effective therapies.

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