Protagenic Therapeutics Updates Timeline for Commencement of Patient Enrollment for PT00114 Clinical Trial

Rhea-AI Summary

Protagenic Therapeutics (Nasdaq: PTIX) announced that the FDA has requested the company to provide clinical sites with ready-to-inject vials instead of drug substances for local formulation. This change allows Protagenic to maintain control over the final drug product formulation. The company plans to comply with this directive and refile its Investigational New Drug (IND) application to initiate patient enrollment in Q4 2021. The company focuses on developing therapies for stress-related neurologic disorders.

Positive

• FDA guidance allows Protagenic to maintain control over drug formulation.
• Company expects to refile IND and begin patient enrollment in Q4 2021.

Negative

• Change in requirements could lead to potential delays in the clinical trial process.

NEW YORK, July 23, 2021 (GLOBE NEWSWIRE) -- Protagenic Therapeutics, Inc. (Nasdaq: PTIX) a biopharmaceutical company focused on developing therapies to treat stress-related neurologic disorders, today announced that upon reviewing its investigational new drug (IND) application filed on June 29^th, the U.S. Food and Drug Administration (FDA) has requested that Protagenic provide clinical sites with ready-to-inject clinical vials rather than providing site pharmacies with drug substance to be formulated locally. Implementing this FDA guidance will have the added benefit of Protagenic’s control of the formulation of the final drug product. Protagenic is immediately implementing this required change. As a result of this development, the company expects to refile its IND and commence patient enrollment in the 4^th quarter of 2021.

About Protagenic Therapeutics, Inc.

Protagenic Therapeutics, Inc. (Nasdaq: PTIX) is a pre-clinical biopharmaceutical company endeavoring to develop first-in-class neuro-active peptides into human therapeutics to treat several stress related disorders. For more information, visit http://www.protagenic.com.

Forward-Looking Statements

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding Protagenic Therapeutics’ product candidates and pre-clinical development and clinical trial plans and activities. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the pre-clinical testing and eventual clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in pre-clinical and clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors described under the Risk Factors section of our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission.. Protagenic Therapeutics cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Protagenic undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

Analyst Contact:
Alexander K. Arrow, MD, CFA
Chief Financial Officer
213-260-4342
alex.arrow@protagenic.com

Media Contact:
James Carbonara
Hayden IR
(646)-755-7412
james@haydenir.com

FAQ

What recent FDA guidance did Protagenic Therapeutics receive?

Protagenic Therapeutics was requested by the FDA to provide ready-to-inject clinical vials for their IND application instead of drug substances for local formulation.

When will Protagenic Therapeutics begin patient enrollment for their clinical trial?

Protagenic Therapeutics plans to commence patient enrollment in the fourth quarter of 2021.

What is the focus of Protagenic Therapeutics?

The company focuses on developing therapies to treat stress-related neurologic disorders.

What is the significance of the IND application for Protagenic Therapeutics?

The IND application is crucial for Protagenic to initiate clinical trials and bring their drug candidates to market.

What potential impact does the FDA's request have on Protagenic's timeline?

The FDA's request for ready-to-inject vials may cause changes in Protagenic's timeline for clinical trials, potentially leading to delays.