Climb Bio Announces CLYM116 Preclinical Data Highlighting Potential for Best-In-Class Therapeutic for IgAN
Climb Bio (NASDAQ:CLYM) has announced promising preclinical data for CLYM116, its novel therapeutic candidate for IgA nephropathy (IgAN). The study demonstrated superior performance compared to first-generation anti-APRIL monoclonal antibody sibeprenlimab, showing a 2-3 times longer half-life and deeper IgA reduction of >70%.
The company plans to initiate Phase 1 trials in Q4 2025, with initial data expected by mid-2026. CLYM116's subcutaneous formulation showed 85% bioavailability with favorable tolerability. The market opportunity is significant, estimated at $10-20 billion in the US alone, with approximately 170,000 patients.
Climb Bio (NASDAQ:CLYM) ha condiviso dati preclinici incoraggianti su CLYM116, il nuovo candidato terapeutico per la nefropatia da IgA (IgAN). Lo studio ha evidenziato prestazioni superiori rispetto al monoclonale anti-APRIL di prima generazione, con una emivita 2-3 volte più lunga e una riduzione dell’IgA superiore al 70%.
L’azienda prevede di avviare prove di fase 1 nel quarto trimestre del 2025, con dati iniziali attesi entro la metà del 2026. La formulazione sottocutanea di CLYM116 ha mostrato un’bio-disponibilità dell’85% con una tollerabilità favorevole. L’opportunità di mercato è significativa, stimata tra 10-20 miliardi di dollari solo negli Stati Uniti, con circa 170.000 pazienti.
Climb Bio (NASDAQ:CLYM) ha revelado datos preclínicos prometedores para CLYM116, su nuevo candidato terapéutico para la nefropatía por IgA (IgAN). El estudio mostró un rendimiento superior frente al anticuerpo monoclonal anti-APRIL de primera generación, con una vida media 2-3 veces mayor y una reducción de IgA superior al 70%.
La empresa planea iniciar ensayos de Fase 1 en el Q4 de 2025, con datos iniciales esperados para mediados de 2026. La formulación subcutánea de CLYM116 mostró una biodisponibilidad del 85% y una buena tolerabilidad. La oportunidad de mercado es considerable, estimada entre $10-20 mil millones solo en EE. UU., con aproximadamente 170.000 pacientes.
Climb Bio(NASDDAQ:CLYM)가 IgA 신병증(IgAN)을 위한 새로운 치료 후보물질 CLYM116에 대해 유망한 전임상 데이터를 발표했습니다. 연구는 1세대 anti-APRIL 단일클론 항체인 sibeprenlimab에 비해 반감기가 2-3배 길고 IgA 감소가 70% 이상로 더 깊은 효과를 보였습니다.
회사는 2025년 4분기에 1상 임상 시작을 계획하고 있으며, 초도 데이터는 2026년 중반으로 예상됩니다. CLYM116의 피하 제형은 생체이용률 85%를 보였고 내약성도 양호했습니다. 시장 기회는 미국에서만 $100억~200억 달러 규모로 추정되며 약 170,000명의 환자들이 존재합니다.
Climb Bio (NASDAQ:CLYM) a annoncé des données précliniques prometteuses pour CLYM116, son nouveau candidat thérapeutique pour la néphropathie à IgA (IgAN). L’étude a démontré des performances supérieures à l’anticorps monoclonal anti-APRIL de première génération, avec une demi-vie 2 à 3 fois plus longue et une réduction d’IgA > 70%.
L’entreprise prévoit de lancer des essais de phase 1 au T4 2025, avec des résultats initiaux attendus d’ici la mi-2026. La formulation sous-cutanée de CLYM116 a montré une biodisponibilité de 85% avec une tolérance favorable. L’opportunité de marché est significative, estimée entre 10-20 milliards de dollars rien qu’aux États-Unis, avec environ 170 000 patients.
Climb Bio (NASDAQ:CLYM) hat positive präklinische Daten für CLYM116, seinen neuen therapeutischen Kandidaten bei IgA-Nephropathie (IgAN), angekündigt. Die Studie zeigte eine überlegene Leistung im Vergleich zum ersten Generator anti-APRIL Monoclonalantibody sibeprenlimab, mit einer 2- bis 3-mal längeren Halbwertszeit und einer tieferen IgA-Reduktion von über 70%.
Das Unternehmen plant Phase-1-Studien im vierten Quartal 2025 zu starten, mit ersten Daten voraussichtlich Mitte 2026. Die subkutane Formulierung von CLYM116 zeigte eine Bioverfügbarkeit von 85% und eine günstige Verträglichkeit. Das Marktpotenzial ist erheblich, geschätzt auf 10-20 Milliarden Dollar allein in den USA, bei etwa 170.000 Patienten.
Climb Bio (NASDAQ:CLYM) أعلنت عن بيانات ما قبل إكلينيكية واعدة لـCLYM116، المرشح العلاجي الجديد لـداء الكُلى IgA (IgAN). أظهرت الدراسة أداءً فائقاً مقارنةً بج monoclonal anti-APRIL من الجيل الأول سِيبِبرينلوبماب، مع نصف عمر أطول بمعدل 2-3 مرات وتخفيض IgA أعمق يتجاوز 70%.
تخطط الشركة لبدء مرحلة التجارب السريرية 1 في الربع الرابع من 2025، مع توقع بيانات أولية بحلول منتصف 2026. أظهر تركيـب CLYM116 تحت الجلد توافر حيوي قدره 85% وتحمل جيد. الفرصة السوقية كبيرة، وقدرت بـ 10-20 مليار دولار في الولايات المتحدة فقط، مع حوالي 170,000 مريض.
Climb Bio (NASDAQ:CLYM) 已公布其用于IgA肾病（IgAN）的新药候选药物 CLYM116 的前临床数据，显示出优于第一代抗APRIL单克隆抗体sibeprenlimab的表现，具有半衰期延长2-3倍和IgA下降深度超过70%的效果。
公司计划在2025年第四季度开启< b>Ⅰ期临床，初步数据预计在2026年中旬公布。CLYM116的皮下注射制剂显示出生物利用度85%，耐受性良好。市场机会显著，估算仅在美国就达到100亿-200亿美元，约有170,000名患者。
- None.
- Phase 1 trials yet to begin - early stage development with associated risks
- Competition from existing first-generation treatments
- Clinical efficacy in humans still unproven
Insights
Climb Bio's CLYM116 shows promising preclinical results with superior IgA reduction and longer half-life versus competitors, potentially addressing a $10-20B market.
Climb Bio's preclinical data for CLYM116 represents a potentially significant advancement in IgA nephropathy (IgAN) treatment. The nonhuman primate study demonstrated several key advantages over sibeprenlimab, a first-generation anti-APRIL antibody: a
What makes CLYM116 particularly interesting is its novel "sweeper" mechanism for targeting APRIL, a key protein involved in IgAN pathogenesis. The enhanced antibody recycling and APRIL elimination observed in mouse models mechanistically explain the superior pharmacodynamic profile seen in primates.
The IgAN market represents a substantial opportunity, estimated at
The development timeline appears reasonable, with Phase 1 trials expected in Q4 2025 and initial data by mid-2026. If CLYM116 maintains its preclinical advantages in human studies, it could potentially capture significant market share in this serious disease where 30-40% of patients develop kidney failure within 10 years of diagnosis. The parallel development in China through Mabworks provides additional data generation opportunities and market potential.
New preclinical data demonstrate deeper IgA reduction and a longer half-life compared to first-generation anti-APRIL monoclonal antibody
CLYM116 Phase 1 trial initiation expected in Q4 2025, with initial biomarker and dosing interval data anticipated mid-year 2026
Company to host R&D Spotlight Webcast today, September 29, 2025
WELLESLEY HILLS, Mass., Sept. 29, 2025 (GLOBE NEWSWIRE) -- Climb Bio, Inc. (Nasdaq: CLYM), a clinical-stage biotechnology company developing therapeutics for immune-mediated diseases, today announced results from a completed nonhuman primate (NHP) study comparing CLYM116 to sibeprenlimab, a first-generation anti-APRIL monoclonal antibody. The company is hosting a virtual investor event focused on CLYM116 today, Monday, September 29, 2025, at 8:00 a.m. ET. Climb Bio’s management team will be joined by leading nephrologist Craig E. Gordon, MD, MS, who has over 20 years of experience treating patients with IgA nephropathy (IgAN) and was a co-director of the Evidence Review Team for the recently issued 2025 KDIGO Clinical Practice Guideline for IgAN.
“We are highly encouraged by the differentiated profile observed with CLYM116, as highlighted in our newly shared nonhuman primate data,” said Aoife Brennan, President and CEO of Climb Bio. “CLYM116 is the only known ‘sweeper’ anti-APRIL monoclonal antibody in development, which we believe could provide a compelling clinical profile in IgAN. In this head-to-head preclinical study, our data have shown improvements in pharmacokinetic and pharmacodynamic measures – namely a longer half-life and deeper and more durable IgA reductions – as compared to sibeprenlimab, a first-generation anti-APRIL monoclonal antibody. These data highlight the potential for CLYM116 to provide a differentiated activity profile with less frequent dosing. Notably, the updated KDIGO treatment guideline published earlier this month highlights the need for more active management of IgAN, and we believe that the adoption of these approaches could expand the CLYM116 market opportunity. We are excited to advance CLYM116 development and look forward to initiation of a Phase 1 trial later this year, with initial data anticipated mid-year 2026.”
CLYM116 Data & Event Highlights
New CLYM116 NHP data demonstrate improvement versus sibeprenlimab (first-generation anti-APRIL monoclonal antibody)
- Subcutaneous formulation demonstrated high bioavailability (~
85% ), with a favorable tolerability profile - Prolonged exposure observed compared to sibeprenlimab, with a ~2-3 times longer half-life across doses
- Deeper and more prolonged IgA reduction observed compared to sibeprenlimab after a single subcutaneous administration at equivalent doses (6 mg/kg), with >
70% maximal reduction in IgA observed with CLYM116 - Additional in vivo studies in mice showed enhanced APRIL elimination and antibody recycling relative to sibeprenlimab
CLYM116 advancing towards planned Phase 1 trial in healthy volunteers
- Phase 1 trial expected to initiate in Q4 2025, subject to regulatory clearance, with initial data, including biomarkers and projected dosing interval, anticipated mid-year 2026
- Parallel execution by Mabworks in China expected to provide a complementary Phase 1 dataset
IgAN represents a high unmet need indication, with a well-defined development path
- Progressive autoantibody-mediated renal disease, caused by APRIL-mediated production of pathogenic IgA and deposition of immune complexes in the glomeruli
- Damage to glomeruli leads to proteinuria, kidney injury and loss of kidney function, with 30
-40% of patients developing kidney failure within 10 years of diagnosis - Prior product approvals in IgAN provide precedent regarding study design and registrational endpoints, including use of proteinuria for accelerated approval and estimated glomerular filtration rate (eGFR) for full approval
- Biomarkers (APRIL, IgA) enable rapid assessment of clinical profile during early development
IgAN is a significant market opportunity, estimated at
- Most common primary glomerular disease worldwide, with ~170,000 patients in the US alone
- Typically diagnosed early in life and is likely to require lifelong management
- KDIGO 2025 guideline recommends a lower threshold for biopsy to enable earlier diagnosis and recommends aiming for stricter proteinuria control, with a goal of <0.5 g/day, ideally <0.3 g/day, which may result in earlier and more aggressive disease management
- Updated treatment guidelines highlight importance of reducing pathogenic IgA along with managing the consequences of existing nephron loss, potentially positioning anti-APRIL therapy as a core pillar in the future treatment of IgAN
Webcast Information
The live webcast will be accessible via the “Investors & Media” section of the Climb Bio website: https://ir.climbbio.com/, and an accompanying slide presentation will also be made available. A webcast replay will be available on the Climb Bio website beginning approximately two hours after the webcast event and will be archived for at least 30 days.
About Climb Bio, Inc.
Climb Bio, Inc. is a clinical-stage biotechnology company developing therapeutics for patients with immune-mediated diseases. The Company’s pipeline includes budoprutug, an anti-CD19 monoclonal antibody that has demonstrated B-cell depletion and has potential to treat a broad range of B-cell mediated diseases, and CLYM116, an anti-APRIL monoclonal antibody in development for IgA nephropathy. For more information, please visit climbbio.com.
About CLYM116
CLYM116 is a preclinical-stage monoclonal antibody targeting APRIL (A Proliferation-Inducing Ligand), a key driver of pathogenic B-cell activity in autoimmune diseases. CLYM116 employs a novel pH-dependent bind-and-release mechanism to potently block APRIL signaling, promote lysosomal degradation of APRIL and recycle the antibody to extend its half-life. This differentiated design offers the potential for rapid, deep and durable inhibition of APRIL with a favorable safety profile and less frequent dosing. CLYM116 is being advanced for the treatment of IgA nephropathy and may also have broader utility across other B-cell mediated diseases where APRIL plays a critical role.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding: future expectations, plans and prospects for Climb Bio; expectations regarding the therapeutic benefits, clinical potential and clinical development of budoprutug and CLYM116; expectations regarding the timing of submitting an investigational new drug application or clinical trial application submission for CLYM116; the anticipated timelines for initiating a clinical trial of CLYM116 and reporting initial data; the anticipated benefits of Climb Bio’s license agreement with Beijing Mabworks Biotech Co., Ltd. (“Mabworks”); the sufficiency of Climb Bio’s cash resources for the period anticipated; and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” “will,” “working” and similar expressions. Forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. Climb Bio may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. These risks and uncertainties include, but are not limited to, important risks and uncertainties associated with: the ability of Climb Bio to timely and successfully achieve or recognize the anticipated benefits of its acquisition of Tenet Medicines, Inc. and its license agreement with Mabworks; changes in applicable laws or regulation; the possibility that Climb Bio may be adversely affected by other economic, business and/or competitive factors; Climb Bio’s ability to advance budoprutug and CLYM116 on the timelines expected or at all and to obtain and maintain necessary approvals from the U.S. Food and Drug Administration and other regulatory authorities; obtaining and maintaining the necessary approvals from investigational review boards at clinical trial sites and independent data safety monitoring boards; replicating in clinical trials positive results found in early-stage clinical trials and preclinical studies; competing successfully with other companies that are seeking to develop treatments for primary membranous nephropathy, immune thrombocytopenia, systemic lupus erythematosus, IgA nephropathy and other immune-mediated diseases; maintaining or protecting intellectual property rights related to budoprutug, CLYM116 and/or its other product candidates; managing expenses; and raising the substantial additional capital needed, on the timeline necessary, to continue development of budoprutug, CLYM116 and any other product candidates Climb Bio may develop. For a discussion of other risks and uncertainties and other important factors, any of which could cause Climb Bio’s actual results to differ materially from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties and other important factors, in Climb Bio’s most recent filings with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Climb Bio’s views as of the date hereof and should not be relied upon as representing Climb Bio’s views as of any date subsequent to the date hereof. Climb Bio anticipates that subsequent events and developments will cause Climb Bio’s views to change. However, while Climb Bio may elect to update these forward-looking statements at some point in the future, Climb Bio specifically disclaims any obligation to do so, except as required by law.
Investors and Media
Carlo Tanzi, Ph.D.
Kendall Investor Relations
ctanzi@kendallir.com
FAQ
What are the key advantages of CLYM116 over existing IgAN treatments?
When will Climb Bio (CLYM) begin clinical trials for CLYM116?
What is the market size for CLYM116 in IgA nephropathy treatment?
How does CLYM116 work in treating IgA nephropathy?
What percentage of IgAN patients develop kidney failure?
