Rein Therapeutics has paused patient enrollment for peptide LTI-03.

Rein Therapeutics was advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications. Their lead molecule is peptide LTI-03.

The company has secured two U.S. patents, US 12,280,088 and US 12,280,089, for the dry powder peptide formulation of LTI-03, a drug candidate being developed for idiopathic pulmonary fibrosis (IPF) and other fibrotic lung diseases. 


These patents, titled "Dry Powder Formulation of Caveolin-1 Peptides and Methods of Use Thereof”. 


These inventions generally relate to molecular biology, pharmaceutics, and medicine. More particularly, they are concerned with compositions and methods for delivering dry powder therapeutic polypeptide compositions to subjects, such as through delivery to the respiratory system.


The company claims these patents enhance its intellectual property and support the ongoing development of LTI-03 as a potential first-in-class therapeutic option.


Two clinical studies were reported in ClinicalTrials.gov.


NCT04233814, "Safety, Tolerability and Pharmacokinetic Study of LTI-03 in Healthy Adult Subjects", dated Mar. 7, 2022.


NCT05954988, "A Study to Evaluate LTI-03 in Newly Diagnosed Idiopathic Pulmonary Fibrosis (IPF) Patients", dated Aug. 30, 2023.


The primary endpoint for the trial was the incidence of treatment-emergent adverse events (TEAEs) from Day 1 through Week 24. The key secondary endpoint is the efficacy of LTI-03, measured through forced vital capacity (FVC), percent predicted FVC (ppFVC), and high-resolution computed tomography (HRCT).


Review results submitted on 11 June 2025. As reported by Reuters on 12 June 2025, Rein Therapeutics has paused patient enrollment and dosing in a mid-stage trial of its lung disease drug in the U.S. after the USFDA placed a clinical hold. More details about the study's outcome are not available at the site. However, there could be something in the report that prompted the FDA hold. This needs to be investigated.

Shares of the company declined by nearly 10%, according to Reuters. 

Comments

Post a Comment

Popular posts from this blog

Gland Pharma is expected to secure 180-day exclusivity for Angiotensin II Acetate.

Image
This week, Gland Pharma received approval from the US FDA for the Angiotensin II Acetate Injection 2.5 mg/mL. Gland Pharma's Angiotensin II Acetate Injection is a generic version of La Jolla Pharma's Giapreza. Giapreza's sales are approximately $58 million in the U.S. market for the twelve months ending March 2025. Angiotensin II (ATII) is a naturally occurring peptide hormone that produces endocrine, autocrine, paracrine, and intracrine hormonal effects. It is a potent direct vasoconstrictor that narrows both arteries and veins, subsequently raising blood pressure. Its half-life in circulation is approximately 30 seconds; however, in tissue, it may extend to 15-30 minutes. ATII increases the secretion of ADH and ACTH and may enhance sympathetic effects through direct actions on postganglionic sympathetic fibres. Additionally, it acts on the adrenal cortex, prompting the release of aldosterone. Several patents are listed in OB by La Jolla Pharma’s Giapreza product.  Product...
Read more

Medical Reimbursement System in the US, J-Code, and the Potential Impact on 505(b)(2) Applications with Recent Changes

US Medical Reimbursment System The medical reimbursement system in the United States is very complex. I am not aware of any such system existing at the national level in India, so I cannot draw any parallels. In India, health insurance is primarily for hospitalisations, and, based on my information (which is mainly based on my health insurance), other reimbursements are generally not covered. However, I could be wrong. In the United States, there is HCPCS. Healthcare Common Procedure Coding System (HCPCS).  HCPCS is a standardised coding system used mainly for billing and processing health insurance claims, especially for Medicare and Medicaid.  The Centers for Medicare & Medicaid Services (CMS) maintains it. HCPCS is divided into two levels: Level I, which uses Current Procedural Terminology (CPT) codes, and Level II, which provides codes for products, supplies, and services not included in CPT.  You will notice that in the United States, almost everything is covered...
Read more