SAB BIO Announces Positive Topline Phase 1 Clinical Results with Potentially Disease-Modifying T1D Therapy SAB-142
SAB BIO (SABS) announced positive topline data from its Phase 1 trial of SAB-142, a potential therapy for type 1 diabetes (T1D). The trial met its primary objectives for safety and pharmacodynamic activity in healthy volunteers. Key findings include:
- Favorable safety profile with doses ranging from 0.03mg/kg to 2.5mg/kg
- No reported serum sickness or anti-drug antibodies
- Demonstrated sustained immunomodulation
- Mechanism of action analogous to rabbit ATG
The company plans to advance SAB-142 into Phase 2b clinical development in 2025, targeting adult and pediatric patients with new-onset T1D. The therapy aims to be the first fully human biologic enabling outpatient dosing to delay T1D onset or progression.
SAB BIO (SABS) ha annunciato risultati positivi preliminari dal suo studio di Fase 1 su SAB-142, una potenziale terapia per il diabete di tipo 1 (T1D). Lo studio ha raggiunto i suoi obiettivi primari in termini di sicurezza e attività farmacodinamica nei volontari sani. Risultati chiave includono:
- Profilo di sicurezza favorevole con dosi variabili da 0.03mg/kg a 2.5mg/kg
- Assenza di segnalazioni di malattia siero e anticorpi anti-farmaco
- Dimostrazione di immunomodulazione sostenuta
- Meccanismo d'azione analogo all'ATG di coniglio
L'azienda prevede di portare avanti SAB-142 nella fase di sviluppo clinico 2b nel 2025, mirando a pazienti adulti e pediatrici con T1D di nuova insorgenza. La terapia punta a essere il primo biologico completamente umano che consente somministrazioni ambulatoriali per ritardare l'insorgenza o la progressione del T1D.
SAB BIO (SABS) anunció datos preliminares positivos de su ensayo de Fase 1 de SAB-142, una terapia potencial para la diabetes tipo 1 (T1D). El ensayo cumplió con sus objetivos primarios de seguridad y actividad farmacodinámica en voluntarios sanos. Hallazgos clave incluyen:
- Perfil de seguridad favorable con dosis que varían de 0.03mg/kg a 2.5mg/kg
- No se reportaron casos de enfermedad sérica ni anticuerpos anti-fármaco
- Demostración de inmunomodulación sostenida
- Mecanismo de acción análogo al ATG de conejo
La compañía planea avanzar SAB-142 a desarrollo clínico de Fase 2b en 2025, enfocándose en pacientes adultos y pediátricos con T1D de nueva aparición. La terapia tiene como objetivo ser el primer biológico completamente humano que permite dosificaciones ambulatorias para retrasar la aparición o progresión del T1D.
SAB BIO (SABS)는 SAB-142의 1상 임상시험에서 긍정적인 초기 데이터를 발표했습니다. 이는 제1형 당뇨병(T1D)에 대한 잠재적인 치료제입니다. 이 시험은 건강한 자원봉사자에서 안전성과 약리역학적 활성을 위한 주요 목표를 달성했습니다. 주요 발견은 다음과 같습니다:
- 0.03mg/kg에서 2.5mg/kg까지의 용량으로 호의적인 안전성 프로필
- 보고된 혈청병증이나 약물 항체 없음
- 지속적인 면역조절 입증
- 토끼 ATG와 유사한 작용 기전
회사는 2025년에 제1형 당뇨병 새로 발병한 성인 및 소아 환자를 대상으로 2b 단계 임상 개발로 SAB-142를 추진할 계획입니다. 이 치료법은 T1D의 발병이나 진행을 지연시키기 위해 외래 환자에게 투여할 수 있는 첫 번째 완전 인간 생물학적 제제가 되는 것을 목표로 하고 있습니다.
SAB BIO (SABS) a annoncé des données préliminaires positives de son essai de phase 1 sur SAB-142, une thérapie potentielle pour le diabète de type 1 (T1D). L'essai a atteint ses objectifs principaux en matière de sécurité et d'activité pharmacodynamique chez des volontaires en bonne santé. Résultats clés incluent :
- Profil de sécurité favorable avec des doses allant de 0,03 mg/kg à 2,5 mg/kg
- Aucun cas signalé de maladie sérique ou d'anticorps anti-médicament
- Immunomodulation soutenue démontrée
- Mécanisme d'action analogue à l'ATG de lapin
L'entreprise prévoit de faire progresser SAB-142 dans le développement clinique de phase 2b en 2025, ciblant les patients adultes et pédiatriques avec un T1D nouvellement diagnostiqué. La thérapie vise à être le premier biologique entièrement humain permettant une posologie ambulatoire pour retarder l'apparition ou la progression du T1D.
SAB BIO (SABS) hat positive vorläufige Daten aus seiner Phase-1-Studie zu SAB-142, einer potenziellen Therapie für Typ-1-Diabetes (T1D), veröffentlicht. Die Studie hat ihre primären Ziele in Bezug auf Sicherheit und pharmakodynamische Aktivität bei gesunden Freiwilligen erreicht. Wichtige Ergebnisse umfassen:
- Günstiges Sicherheitsprofil mit Dosen von 0,03 mg/kg bis 2,5 mg/kg
- Keine berichteten Serumkrankheiten oder Anti-Arzneimittel-Antikörper
- Nachgewiesene nachhaltige Immunmodulation
- Wirkmechanismus analog zu Kaninchen-ATG
Das Unternehmen plant, SAB-142 in die klinische Entwicklung der Phase 2b im Jahr 2025 fortzusetzen, wobei Erwachsene und Kinder mit neu aufgetretenem T1D im Fokus stehen. Die Therapie soll das erste vollständig humane Biologikum werden, das eine ambulante Dosierung zur Verzögerung des Auftretens oder Fortschreitens von T1D ermöglicht.
- Phase 1 trial met primary objectives for safety and pharmacodynamic activity
- Zero reported serum sickness and anti-drug antibodies at target dose
- Favorable safety profile supporting chronic dosing in ambulatory setting
- Clear path to Phase 2b clinical development in 2025
- None.
Insights
The Phase 1 results for SAB-142 represent a significant milestone in the development of type 1 diabetes therapeutics. The data reveals three important advantages that position this therapy favorably in the $27 billion global T1D market:
1. Superior Safety Profile: The absence of serum sickness and anti-drug antibodies at therapeutic doses (up to 2.5mg/kg) is particularly noteworthy, as these are common challenges with existing immunotherapies. This clean safety profile could enable chronic dosing in outpatient settings, a major differentiator from current hospital-based treatments.
2. Novel Mechanism: SAB-142's mechanism of action, analogous to rabbit ATG but in a fully human format, suggests potential for better tolerability and reduced immunogenicity compared to existing animal-derived alternatives. The sustained immunomodulation observed indicates possible longer-term therapeutic benefits.
3. Market Positioning: As potentially the first fully human biologic with a validated broad mechanism of action for T1D, SAB-142 could address a critical gap in the treatment landscape. The ability to administer in outpatient settings could significantly reduce healthcare costs and improve patient compliance.
The advancement to Phase 2b trials in both adult and pediatric populations demonstrates confidence in the therapy's potential. However, investors should note that success in Phase 1 safety trials, while promising, doesn't guarantee efficacy in larger patient populations. The true value proposition will become clearer with Phase 2b efficacy data.
- 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
- Study results support that SAB-142 is well-positioned for re-dosing in outpatient setting for type 1 diabetes
- 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:
- 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.
- 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
- Sustained Immunomodulation: SAB-142 demonstrated a clinically validated multi-target MOA with sustained immunomodulation.
- 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
khollon@sab.bio
Investor Relations:
Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com
Chris Calabrese
LifeSci Advisors
ccalabrese@lifesciadvisors.com
FAQ
What were the key results of SAB-142's Phase 1 trial for type 1 diabetes (SABS)?
When will SAB BIO (SABS) begin Phase 2b trials for SAB-142?
What is the mechanism of action (MoA) of SAB-142 (SABS)?
What dosing range was tested in the SAB-142 Phase 1 trial (SABS)?
