Zosano Pharma Announces Publication of Clinical Data Demonstrating Comparable Immunogenicity of a Trivalent Influenza Vaccine Formulated on its Transdermal Microneedle System Versus an Intramuscular Injection of the Vaccine at a Higher Dose

Rhea-AI Summary

Zosano Pharma Corporation (NASDAQ: ZSAN) announced the publication of Phase 1 clinical trial data regarding its transdermal microneedle system in the Journal of Vaccines and Immunology. The study showed that a low dose of a trivalent influenza vaccine met EMEA efficacy guidelines and was well tolerated. Notably, participants reported less pain with the microneedle patch compared to intramuscular injections. Zosano's innovative system aims to reduce administration burdens and enhance patient compliance, presenting a significant advancement in vaccine delivery technology.

Positive

• Phase 1 trial demonstrated that a low dose of influenza vaccine met EMEA's efficacy guidelines.
• Participants preferred microneedle patch application, reporting it as less painful than intramuscular injections.
• Transdermal microneedle system may reduce administration burdens and improve patient compliance.

Negative

• None.

—Data published in the Journal of Vaccines and Immunology—

FREMONT, Calif., Jan. 05, 2022 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced the publication of Phase 1 clinical trial data in an article titled, “Immunogenicity and Safety of Inactivated Influenza Split-Virion Vaccine Administered via a Transdermal Microneedle System” in the Journal of Vaccines and Immunology. The data demonstrated that a low dose of a trivalent influenza vaccine administered via its transdermal microneedle system produced antibody levels that met EMEA’s three guidelines for influenza vaccine efficacy and was generally well tolerated.

“We are excited to report these results, which show that a lower dose of an influenza vaccine administered using our transdermal microneedle system produced antibody levels similar to an intramuscular injection of the same vaccine at a higher dose,” said Mahmoud Ameri, Ph.D., vice president of research and development at Zosano. “Notably, a number of diverse immune cells are present in the skin, and therefore, we believe administration of a vaccine via the outer layers of dermis has the potential to result in an enhanced immune response.”

Dr. Ameri continued, “Additionally, there are several disadvantages of intramuscular or subcutaneous injections, including the necessity for medical personnel to administer the vaccines, pain, and the risk of needlestick injury which is estimated to cost $535 million per year globally to treat. With our transdermal microneedle system, we have the potential to reduce these burdens, as well as improve patient compliance. These data further support the broad potential of our transdermal microneedle system and highlight the need to modernize the drug delivery technologies currently being used.”

The single-center, randomized Phase 1 study enrolled 90 subjects between the ages of 18 to 40 years to receive a trivalent influenza vaccine containing strains A/H1N1, A/H3N2, and B. Volunteers were randomized to receive the vaccine either via a transdermal microneedle system patch (10 g) worn for 5 minutes, the same patch worn for 15 minutes, or by intramuscular injection (15 g). Antibody levels were measured at Day 21 and compared to EMEA guidelines to assess immunogenicity of the treatment groups. All three EMEA criteria, including seroconversion rate, mean increase in hemagglutinin inhibition titer, and percentage of seroprotected subjects, were met for all three influenza strains in all treatment groups. Additionally, on day 21, most study participants considered microneedle patch application and removal to be less painful than intramuscular injection, and most considered the patch to be their first choice for mode of administration. The transdermal microneedle patch was generally well tolerated.

About Zosano Pharma
Zosano Pharma Corporation is a clinical-stage biopharmaceutical company focused on developing products where rapid administration of approved molecules with established safety and efficacy profiles may provide substantial benefit to patients, in markets where patients remain underserved by existing therapies. The company’s transdermal microneedle system technology consists of titanium microneedles coated with drug that are designed to enable rapid systemic administration of therapeutics to patients. Zosano’s lead product candidate is M207, which is a proprietary formulation of zolmitriptan designed to be delivered via its transdermal microneedle system technology, as an acute treatment for migraine. Learn more at www.zosanopharma.com.

Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical facts contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the benefits and potential uses of the company’s transdermal microneedle system, the potential benefits and availability of M207 for patients, the potential benefits and availability of an influenza vaccine administered via the company’s transdermal microneedle system and other future events and expectations described in this press release. Readers are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “might,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “forecast,” “designed,” “scheduled,” “goal,” “approximately” or the negative of those words or other comparable words to be uncertain and forward-looking. These statements are subject to risks and uncertainties that are difficult to predict, and actual outcomes may differ materially. These include risks and uncertainties, without limitation, associated with the company’s ability to obtain additional cash resources to continue operations, the process of discovering, developing and commercializing products that are safe and effective for use as human therapeutics, risks inherent in the effort to build a business around such products and other risks and uncertainties described under the heading “Risk Factors” in the company’s most recent annual report on Form 10-K and quarterly reports on Form 10-Q. Although Zosano believes that the expectations reflected in these forward-looking statements are reasonable, Zosano cannot in any way guarantee that the future results, level of activity, performance or events and circumstances reflected in forward-looking statements will be achieved or occur. All forward-looking statements are based on information currently available to Zosano and Zosano assumes no obligation to update any such forward-looking statements.

Zosano Contacts:
Christine Matthews
Chief Financial Officer
510-745-1200

Zosano PR:
Sylvia Wheeler or Alexandra Santos
swheeler@wheelhouselsa.com or asantos@wheelhouselsa.com

FAQ

What are the results of Zosano's Phase 1 clinical trial with the influenza vaccine?

The trial showed that a low dose of the influenza vaccine met EMEA efficacy guidelines and was well tolerated.

Which vaccine was tested in Zosano's Phase 1 trial?

Zosano tested a trivalent influenza vaccine containing strains A/H1N1, A/H3N2, and B.

What delivery method did Zosano's trial utilize?

The trial utilized a transdermal microneedle system for vaccine administration.

What are the potential benefits of Zosano's microneedle system?

The microneedle system may improve patient compliance and reduce administration burdens associated with traditional injections.

How did participants respond to the microneedle patch compared to injections?

Most participants found the microneedle patch application and removal less painful than intramuscular injections.