ACELYRIN, INC. Announces Lonigutamab Phase 1/2 Proof-Of-Concept Data to be Shared During Late-Breaking Oral Presentation at ENDO 2024
ACELYRIN announced that positive proof-of-concept data from its Phase 1/2 trial of lonigutamab, a subcutaneous anti-IGF-1R antibody, will be presented at the Endocrine Society's Annual Meeting (ENDO 2024) in Boston. Lonigutamab is designed to treat thyroid eye disease (TED). The presentation, led by Dr. Shoaib Ugradar, will take place on June 3, 2024, from 2:00pm to 2:15pm ET. This announcement is significant as lonigutamab is the first subcutaneous treatment to show clinical responses in TED patients, utilizing the only FDA-approved mechanism for the disease.
- Positive proof-of-concept data from Phase 1/2 trial.
- Presentation at a high-profile event (ENDO 2024).
- Lonigutamab is the first subcutaneous anti-IGF-1R to show clinical responses in TED patients.
- Utilizes FDA-approved mechanism of action for TED treatment.
- Presentation led by a reputable expert, Dr. Shoaib Ugradar.
- Data is still in Phase 1/2, indicating early-stage results.
- No detailed efficacy or safety data provided in the press release.
- Potential risks of over-reliance on a single mechanism of action.
Insights
ACELYRIN’s announcement about the Phase 1/2 trial data for lonigutamab in thyroid eye disease (TED) is significant. Lonigutamab is a humanized IgG1 monoclonal antibody administered subcutaneously, targeting the insulin-like growth factor-1 receptor (IGF-1R). Clinical responses in TED patients mark a noteworthy achievement in this space. Currently, inhibition of IGF-1R is the only FDA-approved treatment mechanism for TED, making these findings particularly impactful.
For retail investors, it’s essential to understand that a positive outcome in these trials could pave the way for advanced clinical stages and eventual FDA approval. Phase 1/2 trials primarily focus on safety and early efficacy, so the mention of ‘positive proof-of-concept data’ suggests promising initial safety and efficacy results. Lonigutamab’s subcutaneous administration route also offers convenience compared to intravenous treatments, potentially enhancing patient compliance and treatment outcomes.
Considering the unmet needs in TED treatment, if successful, lonigutamab could capture a significant market share. This could drive up ACELYRIN's stock value in the long term. However, retail investors should be cognizant of the inherent risks in drug development and the time it takes for drugs to go from trials to market.
From a financial perspective, ACELYRIN's progress in the Phase 1/2 trial for lonigutamab is an encouraging development. Positive clinical data can significantly influence investor sentiment and stock performance. It demonstrates not only the potential effectiveness of lonigutamab but also ACELYRIN’s capability in advancing its drug pipeline.
Retail investors should note that the announcement of positive trial data can lead to short-term stock price increases. This is often driven by market speculation and optimism. However, the company remains in the early stages of clinical development, which poses risks such as potential setbacks in later trial phases or regulatory hurdles. Investors should weigh these risks against the possible long-term benefits.
Furthermore, participating in a late-breaking oral presentation at a prestigious conference like ENDO 2024 can enhance ACELYRIN’s visibility and credibility within the scientific community, potentially attracting strategic partnerships or investments.
Lonigutamab is the first subcutaneous anti-IGF-1R to demonstrate clinical responses in thyroid eye disease (TED) patients
LOS ANGELES, May 29, 2024 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced that positive proof-of-concept data from an ongoing Phase 1/2 trial of lonigutamab in thyroid eye disease (TED) will be shared as a late breaking oral presentation at the Endocrine Society’s Annual Meeting (ENDO 2024), taking place from June 1-4 in Boston, MA. Lonigutamab is a subcutaneously (SC) delivered humanized IgG1 monoclonal antibody targeting the insulin-like growth factor-1 receptor (IGF-1R). Inhibition of IGF-1R is the only FDA-approved mechanism of action for the treatment of TED.
Presentation details are as follows:
Title: Preliminary Safety And Efficacy Of Subcutaneous Lonigutamab (anti-IGF-1R) From A Phase 1/2 Proof Of Concept Study In Patients With Thyroid Eye Disease
Date/Time: Monday, June 3; 2:00pm - 2:15pm ET
Presenter: Dr. Shoaib Ugradar, Department of Orbital and Oculoplastic Surgery, Private Practice; The Jules Stein Eye Institute, University of California
About the Phase 1/2 Trial
The Phase 1/2 clinical trial (NCT05683496) is a multi-center trial evaluating the safety and efficacy of lonigutamab dosed subcutaneously in three cohorts of patients with active thyroid eye disease (TED). Cohort 1 is placebo-controlled testing lonigutamab 40mg every three weeks (Q3W) through six weeks, cohort 2 is open label testing a 50mg loading dose followed by 25mg every week (QW), and cohort 3 is open label testing every four weeks (Q4W) dosing.
For more information about the Phase 1/2 trial, please visit www.clinicaltrials.gov.
About Thyroid Eye Disease
Thyroid Eye Disease (TED) is a vision-threatening autoimmune disease in which there is both inflammation and expansion of the tissues behind the eye, resulting in eye bulging – known as proptosis – that may result in the subsequent inability to close the eyelids. Double vision, or diplopia, can occur, as well as the potential for compression of the retinal nerve, which can lead to blindness. Thus, TED is a progressive, chronic inflammatory disease where longer-term treatment has the potential to improve depth and durability of response. More than 100,000 people in the United States are estimated to suffer from TED.
About Lonigutamab (anti-IGF-1R)
Lonigutamab is a humanized IgG1 monoclonal antibody targeting the IGF-1 receptor and is delivered subcutaneously. Relative to standard of care, lonigutamab binds to a distinct epitope, which results in internalization of the receptor within minutes, and in preclinical binding and functional laboratory assays, it has been shown to be 75-fold more potent. The characteristics of lonigutamab that enable subcutaneous delivery may also enable the potential for longer-term dosing, which we believe may improve depth and durability of clinical response. Based on our preclinical and pharmacodynamic data from our completed single ascending dose study with lonigutamab, we can potentially optimize the therapeutic window utilizing the SC route of administration.
About ACELYRIN, INC.
ACELYRIN, INC. (Nasdaq: SLRN) is a Los Angeles area-based late-stage clinical biopharma company – with additional operations in the San Francisco Bay area – focused on providing patients life-changing new treatment options by identifying, acquiring, and accelerating the development and commercialization of transformative medicines. ACELYRIN has two programs in late-stage clinical development. Lonigutamab is a subcutaneously delivered monoclonal antibody targeting IGF-1R advancing into Phase 2b/3 development for the treatment of thyroid eye disease. Izokibep is a next generation inhibitor of IL-17A in Phase 2b/3 development for the treatment of psoriatic arthritis, hidradenitis suppurativa and uveitis.
For more information about ACELYRIN, visit us at www.acelyrin.com or follow us on LinkedIn and X.
Forward Looking Statements
This press release contains forward-looking statements including, but not limited to, statements related to ACELYRIN’s expectations regarding its cash runway and sufficiency of its cash resources; ACELYRIN’s plan to take lonigutamab through late-stage development milestones; the potential future success of ACELYRIN’s izokibep program; anticipated development activities including the planned initiation and timing of clinical trials, and/or the availability of clinical data; the therapeutic potential of ACELYRIN’s product candidates; and other statements that are not historical fact. These forward-looking statements are based on ACELYRIN’s current plans, objectives and projections, and are inherently subject to risks and uncertainties that may cause ACELYRIN’s actual results to materially differ from those anticipated in such forward-looking statements. Such risks and uncertainties include, without limitation, those associated with the successful completion of development and regulatory activities with respect to ACELYRIN’s product candidates; the timing and results of ACELYRIN’s clinical trials, including the risk that future clinical trial results could differ materially and adversely from prior clinical trial results or data; maintaining and defending intellectual property protection; delays or failures to secure adequate supply of its product candidates; ACELYRIN’s failure to realize the expected benefits of its acquisition of additional programs; legal proceedings and other risks and uncertainties affecting ACELYRIN including those described from time to time under the caption “Risk Factors” and elsewhere in ACELYRIN’s current and future reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2023. Forward-looking statements contained in this press release are made as of this date, and ACELYRIN undertakes no duty to update such information except as required under applicable law.
ACELYRIN Contacts:
Tyler Marciniak
Vice President of Investor Relations,
Communications and Advocacy
investors@acelyrin.com
media@acelyrin.com
FAQ
What is the significance of ACELYRIN's Phase 1/2 trial data for lonigutamab?
When and where will the lonigutamab trial data be presented?
What is lonigutamab and what does it treat?
Who will present the lonigutamab trial data?
What is the FDA-approved mechanism of action for TED treatment?
