重大事件
即時報告
8-K
2026-06-24
Absci 公佈 ABS-201 第一期臨床試驗中期陽性數據，安全性良好
AI 繁中摘要
Absci 公佈 ABS-201 第一期 HEADLINE 臨床試驗中期陽性數據 🧬
申報類型：8-K（Exhibit 99.1）
臨床階段生物科技公司 Absci（Nasdaq: ABSI）於 2026 年 6 月 24 日公佈，其針對泌乳素受體（PRLR）的創新抗體 ABS-201，在首個人體第一期臨床試驗（HEADLINE 試驗）中取得正面中期數據。
試驗設計：隨機、雙盲、安慰劑對照，評估 ABS-201 在健康志願者（包括雄激素性脫髮 AGA 患者）中的安全性與藥代動力學（PK）。中期數據涵蓋 32 名健康成人，已完成四個預定單次遞增劑量（SAD）組別：150 mg、450 mg、900 mg 及 1800 mg 靜脈注射。
關鍵中期結果：
- 安全性：藥物整體耐受性良好，未報告任何嚴重不良事件。所有治療相關不良事件均屬輕度，最常見為頭痛（4 名受試者）。僅出現一例中度頭痛，經評估與研究藥物無關。
- 藥代動力學：基於所有 SAD 組別的可用中期數據（包括低劑量組別第 56 天跟進），ABS-201 的半衰期估計至少為 65 天，支持每六個月僅需注射 2 至 3 次的給藥間隔，有待後續跟進確認。
- 免疫原性：中期數據顯示抗藥抗體對 PK 無明顯影響。
基於 SAD 安全性及 PK 數據，試驗已進入 AGA 患者的皮下多重遞增劑量（MAD）階段，評估 300 mg、600 mg 及 1200 mg 皮下注射或安慰劑。
管理層展望：
Absci 首席醫學官 Ransi Somaratne 表示，對目前的安全性、PK 及免疫原性資料感到鼓舞，期待在 MAD 部分進一步確認 ABS-201 的臨床特徵，並計劃於今年稍後啟動子宮內膜異位症的第二期試驗。
關鍵時間表：
- 中期概念驗證數據：預計 2026 年下半年公佈
- 完整概念驗證數據：預計 2027 年初公佈
市場潛力與現有治療局限：
AGA（俗稱雄性禿）影響約 8000 萬美國人。現有 FDA 批准藥物僅有 minoxidil 及 finasteride，療效有限且副作用明顯。ABS-201 透過靶向泌乳素受體刺激毛囊再生，臨床前模型顯示其生髮效果優於 minoxidil，具備差異化潛力。
對投資者的潛在影響：
此中期數據為 ABS-201 的安全性及給藥便利性提供初步支持，若能持續驗證概念，有望成為 AGA 及子宮內膜異位症的同類最佳療法。然而，仍處於早期臨床階段，最終療效及安全性需待完整數據確認，且存在監管審批風險。投資者應密切留意 2026 年下半年及 2027 年初的關鍵數據讀出。
展開英文正文
EX-99.1 2 exhibit991-26x06x23pr.htm EX-99.1 Document Exhibit 99.1 Absci Announces Positive Interim Phase 1 Data from the HEADLINE™ Trial of ABS-201, a Novel Antibody Targeting the Prolactin Receptor (PRLR) Study medication appears well tolerated, with favorable safety data across all blinded single ascending dose (SAD) cohorts Estimated half-life of at least 65 days supports potential for ABS-201 targeted dosing interval of two or three injections over six-month period First multiple ascending dose (MAD) of ABS-201 in cohort of androgenetic alopecia (AGA) participants has been initiated Interim proof-of-concept data anticipated in the second half of 2026, with full proof-of-concept data in early 2027 VANCOUVER, Wash. and NEW YORK, June 24, 2026 -- Absci Corporation (Nasdaq: ABSI), a clinical-stage biopharmaceutical company advancing breakthrough therapeutics designed with generative AI, today reported positive interim Phase 1 data from its first-in-human trial of ABS-201, an investigational anti-prolactin receptor (PRLR) antibody. “We are particularly encouraged by the emerging safety, pharmacokinetic, and immunogenicity profile observed to date," said Ransi Somaratne, MD, Chief Medical Officer of Absci. "We look forward to further characterizing ABS-201’s clinical profile and potential in the ongoing MAD portion of the HEADLINE trial for AGA, and to initiating a Phase 2 trial for endometriosis later this year.” Key Phase 1 Interim Findings The ABS-201 Phase 1 trial (NCT07317544) is an ongoing, first-in-human, randomized, double-blind, placebo-controlled study designed to evaluate the safety and pharmacokinetics (PK) of ABS-201 in healthy volunteers with and without androgenetic alopecia (AGA). These data comprise 32 healthy adult participants enrolled into four planned single ascending dose (SAD) cohorts. Dose levels evaluated were 150 mg, 450 mg, 900 mg and 1800 mg administered intravenously (IV). Interim blinded safety data from these cohorts as of the June 8, 2026 data cutoff are summarized below. Following review of blinded SAD safety and PK data by the trial’s Safety Review Committee, the study has advanced into the subcutaneous multiple ascending dose (MAD) portion in participants with AGA. Safety: Blinded, aggregate interim data suggest study drug was well tolerated and exhibited a favorable safety and tolerability profile. No serious adverse events were reported as of the data cutoff date. All treatment-emergent adverse events (TEAEs) were mild in severity except for a single moderate TEAE (headache) in SAD cohort 3, which was assessed as unlikely related to study treatment. Treatment-related TEAEs were reported in 5 participants and were all mild. The most frequently reported TEAE across cohorts was headache (4 participants). The interim safety data as of the data cutoff date are summarized as follows. Exhibit 99.1 PK: Based on available interim pharmacokinetic data across all four SAD cohorts, including Day 56 follow-up in the lower-dose cohorts, half-life for ABS-201 is estimated to be at least 65 days. These results support the potential for dosing two or three times over a six month period, pending confirmation through continued follow-up across all cohorts. The following graph depicts drug concentrations by dosing group over time. Immunogenicity: No apparent impact of anti-drug antibodies (ADAs) on PK was observed based on interim data in the SAD cohorts. About ABS-201 and Androgenetic Alopecia Androgenetic alopecia, commonly known as male-pattern or female-pattern hair loss, affects approximately 80 million Americans. The condition causes crown balding and receding hairlines in men, and progressive hair thinning in women. Currently, the only FDA-approved treatments – minoxidil and Exhibit 99.1 finasteride – show limited efficacy and notable side effects, leaving patients with limited therapeutic options. ABS-201 represents a novel therapeutic approach targeting prolactin receptors to stimulate hair follicle regeneration and promote durable hair regrowth as demonstrated in in vivo studies. In preclinical studies, the antibody demonstrated statistically significant superior hair regrowth compared to minoxidil in a preclinical mouse model. Absci anticipates interim proof-of-concept data from its ongoing HEADLINE™ study in the second half of 2026, with full proof-of-concept data in early 2027. About the ABS-201 HEADLINE Trial The HEADLINE trial (NCT07317544) is a Phase 1/2a, randomized, double-blind, placebo-controlled, first-in-human trial evaluating the safety, tolerability, and preliminary proof-of-concept of an investigational treatment in participants with or without AGA. The trial is designed to enroll up to 227 healthy adult volunteers across SAD and MAD cohorts. In the SAD phase, participants received IV doses of 150 mg, 450 mg, 900 mg, or 1800 mg of ABS-201 or placebo. The MAD phase is evaluating doses of 300 mg, 600 mg, and 1200 mg SC (subcutaneous), or matching placebo. The primary endpoints are safety and tolerability. Secondary endpoints include pharmacokinetics, pharmacodynamics, immunogenicity, target area hair count (TAHC), target area hair width (TAHW), target area darkening/pigmentation (TAHD), and patient/investigator-reported outcomes. Absci anticipates reporting interim proof-of-concept data in the second half of 2026 and full proof-of-concept data in early 2027. About Absci Absci is advancing the future of drug discovery with generative design to create better biologics for patients, faster. Our Integrated Drug Creation™ platform combines cutting-edge AI models with a synthetic biology data engine, enabling the rapid design of innovative therapeutics that address challenging therapeutic targets. Absci’s approach leverages a continuous feedback loop between advanced AI algorithms and wet lab validation. Each cycle refines our data and strengthens our models, facilitating rapid innovation and enhancing the precision of our therapeutic designs. Alongside collaborations with top pharmaceutical, biotech, tech, and academic leaders, Absci is advancing its own pipeline of AI designed therapeutics including ABS-201™, a novel approach in hair regrowth with the potential to redefine treatment possibilities for androgenetic alopecia, commonly known as male and female pattern hair-loss. ABS-201 is also being investigated as a potential “best-in-class” therapeutic for endometriosis, a condition with significant unmet medical need and market potential. Absci is headquartered in Vancouver, WA, with AI Research Labs in New York City and Serbia, and an Innovation Center in Switzerland. Learn more at www.absci.com or follow us on LinkedIn (@absci), X (@Abscibio) and YouTube. Absci® standard character mark, ABS-201™, and Integrated Drug Creation™ are trademarks and registered trademarks of Absci Corporation. Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding any or all of the following: development and clinical progress of Absci's pipeline programs, including ABS-201, the design, enrollment, conduct, and timelines of our ongoing Phase 1/2a HEADLINE™ trial of ABS-201 for androgenetic alopecia; the anticipated timing of an interim proof-of-concept data readout for ABS-201 in the second half of 2026 and full proof-of-concept data in early 2027; the potential advancement of ABS-201 into Phase 3 development; the therapeutic potential of ABS-201 as a treatment for endometriosis, the anticipated characteristics and product profile of ABS-201 as a drug product; projections regarding potential market opportunity based on various assumptions, including potential regulatory approval, the final approved label, and the evolving competitive landscape, any of which could cause our actual addressable market to differ materially from these projections; and Absci’s strategy and goals; and expected benefits of its collaborations with partners. Risks that contribute to the uncertain nature of the forward-looking statements include, without limitation, the risk that the Company’s research and development programs and product candidates, including those product candidates under clinical investigation, may not demonstrate the requisite safety, efficacy, or other attributes to warrant further development or to achieve regulatory approval, the risk that results observed in prior studies of the Company’s product candidates, including preclinical studies and clinical trials, will not be observed in ongoing or future studies involving these product candidates or that interim or preliminary clinical data may not be predictive of final clinical trial results, the risk of a delay or difficulties in the manufacturing of the Company’s product candidates or in the enrollment of patients in the Company’s ongoing and Exhibit 99.1 planned clinical trials, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials, changes in the therapeutic, regulatory, or competitive landscape for which the Company’s product candidates are being developed, the amount and type of data to be generated or otherwise to support regulatory approval, and any adverse events or other negative results that may be observed during preclinical or clinical development), the risk that its product candidates may not produce expected therapeutic benefits or may cause unanticipated adverse effects, and risks relating to regulatory interactions and the outcome of such interactions. For a discussion of other risks and uncertainties, please refer to those under the heading “Risk Factors” in Absci Corporation’s most recent quarterly report on Form 10-Q and in any other subsequent filings made by Absci Corporation with the U.S. Securities and Exchange Commission. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date they are made. We disclaim any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law. Investor Contact Alexander D.H. Khan Corporate Vice President Head of Investor Relations [email protected] Media Contact [email protected]