SAB-142 shows favorable safety and pharmacodynamic activity in Phase 1 trial, advancing to Phase 2b for type 1 diabetes.
Quiver AI Summary
SAB BIO announced positive results from its Phase 1 trial of SAB-142, a novel immunotherapy aimed at delaying the onset of type 1 diabetes (T1D). The trial, involving healthy volunteers, demonstrated that SAB-142 was well-tolerated without causing serum sickness or anti-drug antibodies, indicating a favorable safety profile and the potential for chronic outpatient dosing. The company plans to advance SAB-142 into Phase 2b clinical development in 2025 to further assess its effectiveness in treating new-onset T1D in both adult and pediatric patients. The findings emphasize SAB-142's promise as a transformative therapy for T1D, with a unique mechanism of action that could significantly impact patient outcomes. Further details will be discussed in a webinar hosted by SAB BIO.
Potential Positives
- SAB-142 was generally well-tolerated among healthy volunteers, demonstrating a favorable safety profile that supports its use in an ambulatory setting.
- Data from the Phase 1 trial confirmed that SAB-142 does not cause serum sickness or anti-drug antibodies at the target dose, validating its safety for future dosing.
- The trial results show clear pharmacologic activity for SAB-142, positioning it as a promising candidate to delay the onset or progression of type 1 diabetes.
- SAB BIO plans to advance SAB-142 into a Phase 2b trial in 2025, indicating a positive trajectory towards further clinical development and potential market introduction.
Potential Negatives
- The reliance on a single candidate, SAB-142, for treating a complex condition like type 1 diabetes may increase risks related to market dependence if the subsequent phases of clinical trials do not yield successful outcomes.
- The forward-looking statements about future expectations introduce significant uncertainty, presenting a risk to investors and stakeholders about the viability and success of the therapy.
FAQ
What are the key findings of the SAB-142 Phase 1 trial?
The Phase 1 trial showed SAB-142 was well-tolerated, had a favorable safety profile, and met primary objectives for further development.
How does SAB-142 affect type 1 diabetes treatment?
SAB-142 aims to delay the onset or progression of type 1 diabetes, representing a potential breakthrough in autoimmune therapies.
When will the SAB-142 data be presented?
The data will be presented in a webinar on January 28, 2025, at 8:00 AM ET, featuring company executives and experts.
What defines SAB-142's safety profile?
SAB-142 demonstrated a favorable safety profile with 0% incidents of serum sickness and anti-drug antibodies among healthy volunteers.
What is the next step for SAB-142 development?
SAB BIO plans to advance SAB-142 into Phase 2b clinical trials in 2025 to evaluate its efficacy in adults and children with new-onset T1D.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$SABS Hedge Fund Activity
We have seen 7 institutional investors add shares of $SABS stock to their portfolio, and 9 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- RTW INVESTMENTS, LP removed 131,670 shares (-17.2%) from their portfolio in Q3 2024, for an estimated $355,509
- HB WEALTH MANAGEMENT, LLC added 128,800 shares (+118.6%) to their portfolio in Q4 2024, for an estimated $488,692
- SILVER OAK SECURITIES, INCORPORATED removed 51,891 shares (-100.0%) from their portfolio in Q3 2024, for an estimated $140,105
- KOVITZ INVESTMENT GROUP PARTNERS, LLC added 19,201 shares (+inf%) to their portfolio in Q3 2024, for an estimated $51,842
- KESTRA ADVISORY SERVICES, LLC added 11,930 shares (+inf%) to their portfolio in Q3 2024, for an estimated $32,211
- CITADEL ADVISORS LLC added 10,305 shares (+inf%) to their portfolio in Q3 2024, for an estimated $27,823
- BLACKROCK, INC. added 8,413 shares (+61.2%) to their portfolio in Q3 2024, for an estimated $22,715
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Full Release
- SAB-142 was generally well-tolerated among healthy volunteers; data from Phase 1 trial confirms SAB-142 does not cause serum sickness or anti-drug antibodies at target dose
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Study results support that SAB-142 is well-positioned for re-dosing in outpatient setting for type 1 diabetes
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Results will be presented in an R&D webinar event today at 8:00 am ET; registration details below
MIAMI, Jan. 28, 2025 (GLOBE NEWSWIRE) -- SAB BIO (Nasdaq: SABS ), (“SAB BIO” or the “Company”), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that is developing human anti-thymocyte immunoglobulin (hIgG) for delaying the onset or progression of type 1 diabetes (T1D), today announced positive topline data from a Phase 1 trial of SAB-142 in a single-ascending dose among healthy volunteers. The study met its primary objectives related to safety and pharmacodynamic activity enabling SAB-142 to advance to Phase 2b clinical development.
“I am particularly excited with the analysis of the results of our Phase 1 trial, as it marks the successful achievement of another critical milestone for SAB-142,” stated Samuel J. Reich, Chairman and CEO of SAB BIO. “These data show clear and positive pharmacologic activity and strong safety profile for SAB-142, and underscore SAB-142’s potential to change the lives of people impacted by type 1 diabetes. With our initial study objectives met, we believe SAB-142 is now well-positioned to be a transformative therapy in autoimmunity by delaying the progression or onset of type 1 diabetes, and we look forward to advancing this product candidate into Phase 2b clinical development in 2025.”
Phase 1 Trial Summary Data
The SAB-142 Phase 1 trial was designed as a randomized, double-blind, placebo-controlled, single-ascending dose, adaptive design clinical study among healthy volunteers and one cohort of participants with T1D. The objectives include establishing the safety, tolerability, pharmacokinetic (PK), immunogenicity and pharmacodynamic (PD) profile for SAB-142. The topline results reported today showed the following outcomes among healthy volunteer cohorts:
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Favorable Safety Profile:
SAB-142 was generally well-tolerated and demonstrated a favorable safety profile that supports the chronic dosing of SAB-142 in an ambulatory setting.
- The SAB-142 Phase 1 dose range was between 0.03mg/kg up to 2.5mg/kg, which demonstrated favorable safety profile based on the 0% reported serum sickness and anti-drug antibodies.
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Sustained Immunomodulation:
SAB-142 demonstrated a clinically validated multi-target MOA with sustained immunomodulation.
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MoA Analogous to Rabbit ATG:
The mechanism of action (MoA) of SAB-142 was shown to be analogous to rabbit ATG
- The SAB-142 MoA was shown to be analogous to rabbit ATG across multiple parameters correlative to C-peptide preservation.
“Our topline data, which we plan to discuss in further detail at our webinar this morning, successfully demonstrates SAB-142’s impactful autoimmune response,” said Dr. Alexandra Kropotova, M.D., MBA, Executive Vice President and Chief Medical Officer at SAB BIO. “This is consistent with what we’ve seen preclinically, and we believe this validates SAB-142’s unique role as potentially the first and only fully human biologic with a validated and broad mechanism of action to enable outpatient dosing to delay the onset or progression of type 1 diabetes.”
Based on the data, SAB BIO plans to advance SAB-142 into a Phase 2b trial in 2025 to evaluate the therapeutic candidate in adult and pediatric patients with new-onset T1D.
Webinar Details and Registration Information
Today’s webinar will feature presentations from SAB BIO’s management team and T1D Key Opinion Leader (KOL), Michael Haller, MD, the division chief of the Pediatric Endocrinology Division at the University of Florida and Silverstein Family Eminent Scholar Chair in Pediatric Endocrinology.
Date: Tuesday, January 28, 2025
Time: 8:00 a.m. ET
Register for the event here or join the conference call through the Events section of the SAB BIO Company website.
A live question and answer session will follow the formal presentations. A replay of the call will be available in the Presentation section of the SAB BIO Company website upon conclusion of the event.
About SAB BIO
SAB BIO (SAB) is a clinical-stage biopharmaceutical company focused on developing human, multi- targeted, high-potency immunoglobulins (IgGs), without the need for human donors or convalescent plasma, to treat and prevent immune and autoimmune disorders. The Company’s lead asset, SAB-142, targets T1D with a disease-modifying therapeutic approach that aims to change the treatment paradigm by delaying onset and potentially preventing disease progression. Using advanced genetic engineering and antibody science to develop Transchromosomic (Tc) Bovine™, the only transgenic animal with a human artificial chromosome, SAB’s DiversitAb™ drug development production system is able to generate a diverse repertoire of specifically targeted, high-potency, human IgGs that can address a wide range of serious unmet needs in human diseases without the need for convalescent plasma or human donors. For more information on SAB, visit: https://www.SAB.bio/ and follow SAB on Twitter and LinkedIn.
Forward-Looking Statements
Certain statements made in this current report that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “to be,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook,” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding future events, including, the data, development, clinical results, and efficacy of our T1D program and other discovery programs.
These statements are based on the current expectations of SAB BIO and are not predictions of actual performance, and are not intended to serve as, and must not be relied on, by any investor as a guarantee, prediction, definitive statement, or an assurance, of fact or probability. These statements are only current predictions or expectations, and are subject to known and unknown risks, uncertainties and other factors which may be beyond our control. Actual events and circumstances are difficult or impossible to predict, and these risks and uncertainties may cause our or our industry’s results, performance, or achievements to be materially different from those anticipated by these forward-looking statements. A further description of risks and uncertainties can be found in the sections captioned “Risk Factors” in our most recent annual report on Form 10-K, subsequent quarterly reports on Form 10-Q, as may be amended or supplemented from time to time, and other filings with or submissions to, the U.S. Securities and Exchange Commission, which are available at https://www.sec.gov/. Except as otherwise required by law, SAB BIO disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events, or circumstances or otherwise.
CONTACTS
Media Relations:
Kaelan Hollon,
Vice President of Communications
[email protected]
Investor Relations:
Kevin Gardner
LifeSci Advisors
[email protected]
Chris Calabrese
LifeSci Advisors
[email protected]