The first scientific presentation of previously announced data from Cohort 1 of an ongoing Phase 1b clinical trial evaluating low-dose LTI-03 (2.5 mg twice daily) in IPF, confirms positive trends in seven of the eight biomarkers evaluated, suggesting to a potential therapeutic effect
Enrollment in the second cohort evaluating high-dose LTI-03 (5 mg BID) was recently completed in mid-September; Key data expected in the near term
, /PRNewswire/ — Therapeutic Airfoils (NASDAQ:), Inc. (“Aileron”) (NASDAQ: ALRN), a biopharmaceutical company developing a new pipeline of first-in-class drugs to address significant unmet medical needs in orphan pneumonia and pulmonary fibrosis indications, today announced the filing of two briefs detailing the pre-LTI -03 – Clinical and Phase 1b (NCT05954988) leads to idiopathic pulmonary fibrosis (IPF) at 22Second abbreviation International Symposium on Lung and Airway Fibrosis (ICLAF).
The company previously Positive data announced From Cohort 1 of the current Phase 1b clinical trial evaluating low-dose LTI-03 (2.5 mg BID) in patients with IPF. Following low-dose inhalation of LTI-03 in 12 patients over 14 days, a positive trend was observed in seven out of eight biomarkers with evidence of decreased expression among multiple chaperone proteins produced by basal-like cells and fibroblasts contributing to this. to the development of IPF, including data from three biomarkers (collagen synthesis, inflammation, and fibrosis) that were statistically significant, strengthening the potential of LTI-03 to improve lung function and reverse IPF. (Poster) (Abstracts) to be presented at ICLAF will summarize previously disclosed data from Cohort 1.
Preclinical data presented at ICLAF also support the potential therapeutic efficacy of LTI-03 for IPF through precision-cut lung segments (PCLS) performed ex vivo. Preclinical studies demonstrated molecular activity in IPF PCLS explants indicative of fibrosis within five days in culture and LTI-03 broadly attenuated pro-fibrotic proteins and pathways.
Additionally, the company recently announced the completion of enrollment in the second arm of an ongoing phase 1 clinical trial evaluating high doses of LTI-03 (5 mg BID) in 12 patients with IPF. In the trial, eligible patients (n = 24) were randomly assigned (3:1) to receive either LTI-03 inhalation or placebo. The primary objective of the trial is to evaluate the safety and tolerability of LTI-03 in patients with IPF after treatment for 14 consecutive days, with multiple protein biomarkers measured as exploratory endpoints. The company expects to report key data for this group in the near term.
Details of the offers (poster) are as follows:
Presentation Antifibrotic activity of the scaffolding domain Caveolin-1 peptide LTI-03 in ex vivo Micro-cut lung slices from patients with idiopathic pulmonary fibrosis
a summary #: 0186
Presenter: Mr , Cedars-Sinai Medical Center,
Date and time: in /
Presentation Inhaled LTI-03 modulates multiple targets in phase 1b placebo-controlled clinical trial for IPF.
a summary #: 0183
Presenter: Mr , Cedars-Sinai Medical Center,
Date and time: in /
About the phase 1 clinical trial of LTI-03
The phase 1 clinical trial of LTI-03 is a randomized, double-blind, placebo-controlled, multicenter, dose-escalation trial in patients newly diagnosed with IPF who have not received prior treatment with antifibrotic agents for at least 2 months (NCT05954988). Eligible patients are randomly assigned (3:1) to receive one of two doses of inhaled LTI-03 or placebo. The primary objective of the trial is to investigate the safety and tolerability of LTI-03 in patients with IPF after treatment for 14 consecutive days, with multiple protein biomarkers measured as exploratory endpoints.
About IPF
IPF is a chronic lung disease characterized by progressive tissue scarring that prevents proper lung function. It is a progressive, fatal, age-related lung disease that affects approximately 100,000 people worldwide. 1. IPF usually occurs in adults age 65 or older and is usually fatal within two to five years after diagnosis2.
About LTI-03 and Caveolin-1 (Cav1)
LTI-03 is a seven-amino acid peptide, whose sequence is derived from the caveolin scaffolding domain (CSD), an important binding region of the Cav1 protein. Cav1 normally performs a critical function in the prevention of fibrosis by maintaining a balance between the pathways that initiate and stop lung repair and cell motility. Through the CSD, caveolin interacts with a large number of signaling molecules, all of which possess a caveolin-binding region. Cav1 expression is decreased in IPF lung tissue and has been shown to be reduced during the fibrotic phase of bleomycin lung injury in mice. Restoring the balance of important biological signals in the lung may not only slow the decline of lung function, but may also restore healthy lung function by protecting healthy epithelial cells.
on Aileron treatments
Aileron Therapeutics is a biopharmaceutical company developing a novel pipeline of first-in-class drugs to address important unmet medical needs in pulmonary fibrosis and pulmonary fibrosis indications. Aileron’s lead product candidate, LTI-03, is a novel synthetic peptide with a dual mechanism that targets alveolar epithelial cell survival as well as inhibiting fibrotic signaling. Currently, LTI-03 is being evaluated in a phase I clinical trial for the treatment of idiopathic pulmonary fibrosis. Aileron’s second product candidate, LTI-01, is a prototypic enzyme that has completed Phase 1b and Phase 2a clinical trials for the treatment of topical pleural eczema. LTI-01 has received Orphan Drug Designation in the US and EU and Fast Track Designation in the US.
References
1 Pergolizzi, Jr., J., LeQuang, J., Varrassi, M., Breve, F., Magnusson, P., Varrassi, G., (2023). What do we need to know about the high rates of idiopathic pulmonary fibrosis? Review and update the narrative. Springer Nature, published online 24 January 2023. doi: 10.1007/s12325-022-02395-9.
2 Nathan et al. “Long-term course and prognosis of idiopathic pulmonary fibrosis in the new millennium”. Al-Sadr Magazine, Volume 140, Issue 1, pp. 221-229, July 2011.
Forward-looking statements
This press release may contain forward-looking statements for Aileron Therapeutics, Inc. (“Aileron,” “the Company,” “we,” or “our”) within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding: Timing and Expectation of Key Results of Cohort 2 of the Phase 1b Clinical Trial for LTI -03; The Company’s future expectations, plans and prospects, and the adequacy of the Company’s cash resources; Clinical trial status and plans, including timing of data; future product development; and the potential commercial opportunity for LTI-03 and LTI-01. We use words such as “expect”, “believe”, “estimate”, “anticipate”, “hope”, “intend”, “may”, “plan”, “predict”, “project”, “goal”, “potential”. , “will,” “could,” “could,” “should,” “continue,” and other words and terms of similar meaning to help identify forward-looking statements, although not all forward-looking statements contain such words. Definition. 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, and the possibility that the Company will be adversely affected by other economic or business factors. and/or competitive factors, including risks inherent in pharmaceutical R&D, such as: adverse results in the company’s drug discovery, preclinical and clinical development activities, and the risk that results from preclinical studies and early clinical trials may not be replicated in subsequent clinical trials or that partial results For a trial such as the results of Cohort 1 of the Company’s ongoing Phase 1b clinical trial will be indicative of the full results of the trial, the Company’s ability to enroll patients in its clinical trials, and the risks thereof that none of its clinical trials may begin, continue or be completed on time, or at all. ; decisions made by the FDA and other regulatory authorities, investigational review boards at clinical trial sites and publication review boards regarding our development candidates; our ability to obtain, maintain and enforce intellectual property rights for our platform and development candidates; a race; uncertainty about the adequacy of the Company’s cash resources to fund its planned activities for expected periods and the Company’s ability to manage unplanned cash requirements; general economic and market conditions; In addition to 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, 2023 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, on file. With the US Securities and Exchange Commission (“second“), and in subsequent filings the Company makes with the Securities and Exchange Commission. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release, and we expressly disclaim any obligation to update any forward-looking statements, whether as a result of For new information, future events, or otherwise, except as required by law.
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