Rein Therapeutics Granted Two Patents Covering the Novel Formulation and Administration Methods of Dry Powder LTI-03 for the Treatment of Respiratory Diseases

Rhea-AI Summary

Rein Therapeutics (NASDAQ: RNTX) has secured two new U.S. patents (No. 12,280,088 and 12,280,089) for its lead product candidate LTI-03, a synthetic peptide administered through dry powder inhalation. The patents, issued on April 22, 2025, cover both the formulation and therapeutic applications of LTI-03.

The drug features a dual mechanism targeting alveolar epithelial cell survival and inhibition of profibrotic signaling. It is being developed to treat various respiratory conditions including:

• Interstitial lung disease (ILD)
• Idiopathic pulmonary fibrosis (IPF)
• Chronic obstructive pulmonary disease (COPD)
• Asthma and other inflammatory or fibrotic lung conditions

The company plans to initiate a Phase 2 clinical trial of LTI-03 in IPF patients during the first half of 2025.

Positive

• Secured two new USPTO patents strengthening intellectual property protection
• Lead drug candidate advancing to Phase 2 clinical trials
• Drug's dual mechanism potentially addresses significant unmet medical needs
• Multiple potential therapeutic applications across various respiratory diseases

Negative

• Phase 2 trials yet to begin - no clinical efficacy data available
• Early-stage development status indicates long path to potential commercialization

AUSTIN, Texas, April 23, 2025 /PRNewswire/ -- Rein Therapeutics ("Rein") (NASDAQ: RNTX), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, today announced that the U.S. Patent and Trademark Office (USPTO) granted two new patents related to Rein's lead product candidate, LTI-03, a novel, synthetic peptide with a dual mechanism targeting alveolar epithelial cell survival as well as inhibition of profibrotic signaling, which is administered through dry powder inhalation.

U.S. Patent No. 12,280,088 and U.S. Patent No. 12,280,089, both titled, "Dry Powder Formulation of Caveolin-1 Peptides and Methods of Use Thereof", were issued on April 22, 2025. The patents cover LTI-03 dry powder inhalation formulation and its therapeutic use for treating various lung diseases including interstitial lung disease (ILD), idiopathic pulmonary fibrosis (IPF), chronic obstructive pulmonary disease (COPD), asthma and other inflammatory or fibrotic lung conditions.

"These new patents strengthen the proprietary foundation of our inhaled peptide program and support the continued development of LTI-03 as a potential first-in-class therapeutic option for the treatment of IPF and other chronic and acute lung conditions," said Brian Windsor, Ph.D., President and Chief Executive Officer of Rein Therapeutics. "We believe that our dual-mechanism approach has the potential to address the significant unmet need in this patient population, and we look forward to initiating our Phase 2 clinical trial of LTI-03 in patients with IPF in the first half of this year."

About Rein Therapeutics

Rein Therapeutics is a clinical-stage biopharmaceutical company advancing a novel pipeline of first-in-class therapies to address significant unmet medical needs in orphan pulmonary and fibrosis indications. Rein's lead product candidate, LTI-03, is a novel, synthetic peptide with a dual mechanism targeting alveolar epithelial cell survival as well as inhibition of profibrotic signaling.  A Phase 2 clinical trial of LTI-03 for the treatment of idiopathic pulmonary fibrosis is anticipated to be initiated in the first half of this year. Rein's second product candidate, LTI-01, is a proenzyme that has completed Phase 1b and Phase 2a clinical trials for the treatment of loculated pleural effusions. LTI-01 has received Orphan Drug Designation in the U.S. and E.U. and Fast Track Designation in the U.S. For more information, please visit the company's website at reintx.com, or follow them on LinkedIn and X.

Forward-Looking Statements

This press release may contain forward-looking statements of Rein Therapeutics, Inc. ("Rein", the "Company", "we", "our" or "us") within the meaning of the Private Securities Litigation Reform Act of 1995, including statements with respect to: the strength of the patents issued; the timing and expectation of a Phase 2 clinical trial of LTI-03; and future expectations, plans and prospects for the Company. We use words such as "anticipate," "believe," "estimate," "expect," "hope," "intend," "may," "plan," "predict," "project," "target," "potential," "would," "can," "could," "should," "continue," and other words and terms of similar meaning to help identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks and uncertainties related to: changes in applicable laws or regulations; the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors, including risks inherent in pharmaceutical research and development, such as: adverse results in the Company's drug discovery; preclinical and clinical development activities; the risk that the results of preclinical studies and early clinical trials may not be replicated in later clinical trials, including in a Phase 2 clinical trial of LTI-03, or that partial results of a trial will be indicative of the full results of the trial; the Company's ability to enroll patients in its clinical trials; and the risk that any of its clinical trials may not commence, continue or be completed on time, or at all; decisions made by the U.S. Food and Drug Administration and other regulatory authorities; investigational review boards at clinical trial sites and publication review bodies with respect to the Company's development candidates; the Company's ability to obtain, maintain and enforce intellectual property rights for its platform and development candidates; competition; the Company's ability to obtain additional funding and the sufficiency of the Company's cash resources to fund its planned activities for the periods anticipated and the Company's ability to manage unplanned cash requirements; and general economic and market conditions; as well as the risks and uncertainties discussed in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year ended December 31, 2024, which is on file with the United States Securities and Exchange Commission (the "SEC") and in subsequent filings that the Company files with the SEC. These forward-looking statements should not be relied upon as representing the Company's view as of any date after the date of this press release, and we expressly disclaim any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Rein Investor Relations & Media Contact:
Argot Partners
rein@argotpartners.com
212-600-1902

View original content to download multimedia:https://www.prnewswire.com/news-releases/rein-therapeutics-granted-two-patents-covering-the-novel-formulation-and-administration-methods-of-dry-powder-lti-03-for-the-treatment-of-respiratory-diseases-302435142.html

SOURCE Rein Therapeutics, Inc.

FAQ

What patents did Rein Therapeutics (RNTX) receive for LTI-03 in April 2025?

Rein Therapeutics received two USPTO patents (No. 12,280,088 and 12,280,089) covering the dry powder formulation and therapeutic use of LTI-03 for treating various lung diseases.

What medical conditions will RNTX's LTI-03 drug target?

LTI-03 targets multiple respiratory conditions including interstitial lung disease (ILD), idiopathic pulmonary fibrosis (IPF), chronic obstructive pulmonary disease (COPD), asthma, and other inflammatory or fibrotic lung conditions.

When will RNTX begin Phase 2 clinical trials for LTI-03?

Rein Therapeutics plans to initiate Phase 2 clinical trials for LTI-03 in IPF patients during the first half of 2025.

How does Rein Therapeutics' LTI-03 drug work?

LTI-03 works through a dual mechanism, targeting alveolar epithelial cell survival and inhibiting profibrotic signaling, administered via dry powder inhalation.