KALA BIO Announces Topline Results from CHASE Phase 2b Clinical Trial Evaluating KPI-012 for the Treatment of Persistent Corneal Epithelial Defect (PCED) Did Not Meet Primary Endpoint
KALA BIO (NASDAQ:KALA) announced that its CHASE Phase 2b clinical trial evaluating KPI-012 for persistent corneal epithelial defect (PCED) treatment has failed to meet its primary endpoint of complete PCED healing at Week 8. The trial also did not achieve statistical significance for key secondary efficacy endpoints, showing no meaningful difference between KPI-012 treatment arms and placebo.
As a result, KALA will cease development of KPI-012 and its mesenchymal stem cell secretome (MSC-S) platform. The company plans to preserve cash through workforce reduction and other cost-saving measures while evaluating strategic options and engaging in discussions with its secured lender.
KALA BIO (NASDAQ:KALA) ha annunciato che il suo trial CHASE di fase 2b, che valuta KPI-012 per il trattamento della defect epiteliale corneale persistente (PCED), non ha raggiunto l'endpoint primario di guarigione completa del PCED entro la settimana 8. Lo studio non ha ottenuto significatività statistica neanche per i principali endpoint di efficacia secondari, mostrando nessuna differenza significativa tra i bracci di trattamento KPI-012 e il placebo.
Di conseguenza, KALA interromperà lo sviluppo di KPI-012 e della sua piattaforma MSC-S (secretome delle cellule staminali mesenchimali). L'azienda intende conservare liquidità tramite una riduzione del personale e altre misure di contenimento dei costi mentre valuta opzioni strategiche e avvia discussioni con il suo creditore garantito.
KALA BIO (NASDAQ:KALA) anunció que su ensayo CHASE de fase 2b, que evalúa KPI-012 para el tratamiento de la deficiencia epitelial corneal persistente (PCED), no logró cumplir con su objetivo primario de curación completa del PCED en la Semana 8. El ensayo tampoco alcanzó significancia estadística para los principales puntos de eficacia secundaria, mostrando no hay diferencia notable entre los brazos de tratamiento KPI-012 y el placebo.
Como resultado, KALA cesará el desarrollo de KPI-012 y de su plataforma de secreción de células madre mesenquimales (MSC-S). La compañía planea conservar efectivo mediante la reducción de personal y otras medidas de ahorro de costos mientras evalúa opciones estratégicas y mantiene conversaciones con su prestamista garantizado.
KALA BIO (NASDAQ:KALA)는 지속성 각막 상피 결손(PCED) 치료를 위한 KPI-012를 평가하는 CHASE 2b상 임상시험이 주요 1차지표를 달성하지 못했다고 발표했다. 이 시험은 또한 주요 2차 유효성 지표에서도 통계적 유의성을 달성하지 못했고 KPI-012 치료군과 위약 간의 차이가 의미 있는 차이를 보이지 않았다.
결과적으로 KALA는 KPI-012 및 MSC-S(중간구조 줄기세포의 분비물) 플랫폼 개발을 중단할 것이다. 회사는 전략적 옵션을 평가하고 담보 대주와의 논의를 진행하는 동안 인력 감축을 통해 현금을 보존할 계획이다.
KALA BIO (NASDAQ:KALA) a annoncé que son essai CHASE de phase 2b évaluant KPI-012 pour le traitement du défaut épithélial cornéen persistant (PCED) n'a pas atteint son critère principal de guérison complète du PCED à la semaine 8. L'essai n'a pas non plus atteint la signification statistique pour les principaux critères d'efficacité secondaires, ne montrant aucune différence significative entre les bras de traitement KPI-012 et le placebo.
En conséquence, KALA mettra fin au développement de KPI-012 et de sa plateforme MSC-S (secretome des cellules souches mésenchymateuses). L'entreprise prévoit de garder des liquidités en réduisant les effectifs et d'autres mesures d'économie tout en évaluant des options stratégiques et en engageant des discussions avec son prêteur privilégié.
KALA BIO (NASDAQ:KALA) gab bekannt, dass seine CHASE-Phase-2b-Studie zur Bewertung von KPI-012 für die Behandlung von persistierenden Hornhautepitheldefekten (PCED) den primären Endpunkt der vollständigen Heilung des PCED in Woche 8 nicht erreicht hat. Die Studie erreichte auch keine statistische Signifikanz für wichtige sekundäre Wirksamkeitsendpunkte und zeigte keinen signifikanten Unterschied zwischen KPI-012-Behandlungsarmen und Placebo.
Infolgedessen wird KALA die Entwicklung von KPI-012 und seiner MSC-S-Plattform (mesenchymal stem cell secretome) einstellen. Das Unternehmen plant, Geld zu schonen durch Personalabbau und weitere Kosten senkende Maßnahmen, während es strategische Optionen bewertet und Gespräche mit seinem besicherten Gläubiger führt.
KALA BIO (NASDAQ:KALA) أعلنت أن تجربة CHASE من المرحلة 2b التي تقيم KPI-012 لعلاج عيب سطح القرنية المستمر (PCED) فشلت في تحقيق الهدف الأساسي المتمثل في شفاء PCED بشكل كامل في الأسبوع 8. كما لم تحقق التجربة دلالة إحصائية للمخرجات الفعالة الثانوية الرئيسية، حيث لم يظهر فرق معنوي بين ذراع KPI-012 العلاج والدواء الوهمي (placebo).
ونتيجة لذلك، ستقوم KALA بـ إيقاف تطوير KPI-012 وبمنصة MSC-S الخاصة بها (secretome خلايا جذعية متوسطة المكونات). تخطط الشركة للحفاظ على النقد عبر خفض عدد العاملين وغيرها من تدابير خفض التكاليف أثناء تقييم الخيارات الاستراتيجية والتباحث مع المقرض المضمون.
KALA BIO (NASDAQ:KALA)宣布，其评估 KPI-012 用于持续性角膜上皮缺损（PCED）治疗的 CHASE Phase 2b 临床试验未能达到其主要终点，即在第8周实现 PCED 的完全愈合。该试验在关键的次要有效性终点上也未达到统计显著性，显示 KPI-012 各治疗组与安慰剂之间没有显著差异。
因此，KALA 将 停止开发 KPI-012 及其间充质干细胞分泌组分（MSC-S）平台。公司计划通过裁员等成本节约措施来 保留现金，并在评估战略选项和与其有担保的贷款人进行讨论的同时。
- KPI-012 demonstrated favorable safety profile with no treatment-related serious adverse events
- Phase 2b trial failed to meet primary endpoint of complete PCED healing
- Trial failed to achieve statistical significance for key secondary endpoints
- Company ceasing development of KPI-012 and MSC-S platform
- Planned workforce reduction and cost-cutting measures
- Strategic review and discussions with secured lender indicate potential financial concerns
Insights
KALA's KPI-012 fails Phase 2b PCED trial, forcing development termination and workforce reductions while exploring strategic options.
The failure of KALA BIO's CHASE Phase 2b clinical trial represents a significant setback for the company's pipeline. KPI-012, their investigational treatment for persistent corneal epithelial defect (PCED), showed no statistical difference from placebo in either the primary endpoint of complete healing or any key secondary efficacy measures. This outcome sharply contrasts with the previously reported positive Phase 1b results mentioned by their CMO.
The termination of both KPI-012 and KALA's entire mesenchymal stem cell secretome (MSC-S) platform has profound implications. PCED is a rare and serious condition where the cornea fails to heal properly, leading to potential vision loss and severe pain. With limited effective treatments available, this represented a significant unmet medical need and potential market opportunity.
Most concerning for shareholders is KALA's immediate pivot to cash preservation, including workforce reductions and discussions with secured lenders. This suggests serious financial constraints that could threaten the company's operational runway. When biotechnology companies announce they're exploring "strategic options" following a pivotal trial failure, this typically signals consideration of drastic measures such as asset sales, partnerships, or even potential bankruptcy scenarios.
From a clinical development perspective, the complete failure to show any meaningful treatment effect across multiple endpoints suggests fundamental issues with either the drug's mechanism of action or the understanding of the disease pathophysiology. The contrast with earlier positive data raises questions about the reliability of the Phase 1b results or potential differences in trial design, patient population, or endpoint measurements between the studies.
-- Study did not meet primary endpoint of complete healing of PCED at Week 8; secondary endpoints also did not achieve statistical significance --
-- KPI-012 was well-tolerated with no treatment-related serious adverse events observed --
-- KALA to cease clinical development of KPI-012, preserve cash and explore strategic options --
ARLINGTON, Mass., Sept. 29, 2025 (GLOBE NEWSWIRE) -- KALA BIO, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye, today announced that its CHASE (Corneal Healing After SEcretome therapy) Phase 2b clinical trial of KPI-012 for the treatment of persistent corneal epithelial defect (PCED) did not meet the primary endpoint of complete healing of PCED as measured by corneal fluorescein staining. The CHASE trial also failed to achieve statistical significance for key secondary efficacy endpoints and did not show any meaningful difference between either KPI-012 treatment arm and the placebo arm.
Based on the CHASE trial results, KALA plans to cease development of KPI-012 and its mesenchymal stem cell secretome (MSC-S) platform. KALA plans to evaluate its strategic options and as part of its evaluation to engage in discussions with its secured lender. In the interim, the company plans to take steps to preserve cash, including by conducting a reduction in workforce and other cost-saving measures.
“We are disappointed to see the results of the CHASE study given the positive results KPI-012 yielded in the Phase 1b study. KPI-012 continued to be well-tolerated and demonstrated a favorable safety profile but did not demonstrate the efficacy results that would warrant advancing the program for treatment of front-of-the-eye diseases,” said Kim Brazzell, Ph.D., Head of R&D and Chief Medical Officer of Kala BIO. “We would like to thank all of the patients and investigators who participated in in the CHASE trial.”
About CHASE (Corneal Healing After SEcretome therapy) Phase 2b Trial
The CHASE Phase 2b trial is a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study to evaluate the safety and efficacy of two doses of KPI-012 ophthalmic solution (3 U/mL and 1 U/mL) versus vehicle dosed topically QID for 56 days. The CHASE trial randomized 79 patients across 37 sites in the United States and Latin America with verified PCEDs at baseline that will be eligible for inclusion in the primary efficacy analysis. The primary endpoint is complete healing of PCED as measured by corneal fluorescein staining photographs analyzed by a masked central reading center.
About KALA BIO, Inc.
KALA is a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye. KALA’s biologics-based investigational therapies utilize KALA’s proprietary mesenchymal stem cell secretome (MSC-S) platform. KALA’s lead product candidate, KPI-012, is a human MSC-S, which contains numerous human-derived biofactors, such as growth factors, protease inhibitors, matrix proteins and neurotrophic factors. KPI-012 received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration for the treatment of persistent corneal epithelial defect (PCED), a rare disease of impaired corneal healing.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. Any statements in this press release about KALA’s future expectations, plans and prospects, including but not limited to statements about KALA’s plans to evaluate its strategic options, engage in discussions with its secured lender, preserve cash, conduct a reduction in workforce and other cost-saving measures and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” and similar expressions constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainty regarding what, if any, actions KALA’s secured lender may take to recover amounts owed by KALA; KALA’s ability to successfully identify and pursue strategic options on attractive terms, or at all; uncertainty as to whether the reduction in workforce and other cost-saving measures will result in the anticipated savings and be completed when anticipated; and other important factors, any of which could cause KALA’s actual results to differ from those contained in the forward-looking statements, discussed in the “Risk Factors” section of KALA’s Annual Report on Form 10-K, most recent Quarterly Report on Form 10-Q and other filings KALA makes with the Securities and Exchange Commission. These forward-looking statements represent KALA’s views as of the date of this press release and should not be relied upon as representing KALA’s views as of any date subsequent to the date hereof. KALA does not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Investor Contact:
Taylor Steiner
taylor.steiner@precisionaq.com
212-362-1200
FAQ
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