Omeros Corporation Receives Commitment of Over $4 Million from NIDA for Further Development of the Company’s OMS527 Program to Treat Cocaine Use Disorder
Omeros (OMER) has secured a $4.02 million funding commitment from the National Institute on Drug Abuse (NIDA) for the clinical development of OMS527, their oral phosphodiesterase 7 inhibitor targeting cocaine use disorder (CUD).
The funding was triggered by successful drug-drug-interaction safety studies where OMS527 showed no enhancement of cocaine's detrimental effects and demonstrated beneficial outcomes in cocaine-administered animals. The grant will support a Phase 1b clinical trial to assess OMS527's safety and efficacy, with initial data expected in Q4 2025.
OMS527 has shown promising results in animal models across various addictions including cocaine, opioids, nicotine, and alcohol, reducing both craving and relapse. A previous Phase 1 trial demonstrated favorable safety and pharmacokinetics supporting once-daily dosing. With approximately 1.3 million Americans affected by CUD and over 27,000 cocaine-related deaths in 2022, OMS527 aims to address a significant unmet medical need as there are currently no approved treatments for CUD.
Omeros (OMER) ha ottenuto un impegno di finanziamento di 4,02 milioni di dollari dal National Institute on Drug Abuse (NIDA) per lo sviluppo clinico di OMS527, un inibitore della fosfodiesterasi 7 orale mirato al disturbo da uso di cocaina (CUD).
Il finanziamento è stato attivato da studi di sicurezza sui farmaci che hanno mostrato che OMS527 non aumenta gli effetti dannosi della cocaina e ha dimostrato risultati benefici in animali a cui è stata somministrata cocaina. Il grant supporterà un trial clinico di Fase 1b per valutare la sicurezza e l'efficacia di OMS527, con dati iniziali attesi nel quarto trimestre del 2025.
OMS527 ha mostrato risultati promettenti in modelli animali per varie dipendenze, tra cui cocaina, oppiacei, nicotina e alcol, riducendo sia il desiderio che le ricadute. Un precedente trial di Fase 1 ha dimostrato una sicurezza favorevole e una farmacocinetica che supporta la somministrazione una volta al giorno. Con circa 1,3 milioni di americani colpiti da CUD e oltre 27.000 morti correlate alla cocaina nel 2022, OMS527 si propone di affrontare un significativo bisogno medico insoddisfatto, poiché attualmente non ci sono trattamenti approvati per il CUD.
Omeros (OMER) ha asegurado un compromiso de financiamiento de 4,02 millones de dólares del National Institute on Drug Abuse (NIDA) para el desarrollo clínico de OMS527, un inhibidor oral de la fosfodiesterasa 7 dirigido al trastorno por consumo de cocaína (CUD).
El financiamiento fue activado por estudios de seguridad sobre interacciones entre medicamentos, donde OMS527 no mostró un aumento de los efectos perjudiciales de la cocaína y demostró resultados beneficiosos en animales a los que se les administró cocaína. La subvención apoyará un ensayo clínico de Fase 1b para evaluar la seguridad y eficacia de OMS527, con datos iniciales esperados para el cuarto trimestre de 2025.
OMS527 ha mostrado resultados prometedores en modelos animales para diversas adicciones, incluyendo cocaína, opioides, nicotina y alcohol, reduciendo tanto el deseo como las recaídas. Un ensayo previo de Fase 1 demostró una seguridad favorable y una farmacocinética que respalda la dosificación una vez al día. Con aproximadamente 1,3 millones de estadounidenses afectados por CUD y más de 27,000 muertes relacionadas con la cocaína en 2022, OMS527 busca abordar una necesidad médica significativa no satisfecha, ya que actualmente no hay tratamientos aprobados para el CUD.
오메로스 (OMER)는 약물 남용에 관한 국가 연구소(NIDA)로부터 402만 달러의 자금 지원 약속을 확보하여 OMS527의 임상 개발을 진행합니다. OMS527은 코카인 사용 장애(CUD)를 목표로 하는 경구용 포스포디에스터라제 7 억제제입니다.
이 자금 지원은 OMS527이 코카인의 해로운 효과를 증가시키지 않고 코카인을 투여한 동물에서 유익한 결과를 보여준 약물 간 상호작용 안전성 연구의 성공에 의해 촉발되었습니다. 이 보조금은 OMS527의 안전성과 효능을 평가하기 위한 1b상 임상 시험을 지원하며, 초기 데이터는 2025년 4분기에 예상됩니다.
OMS527은 코카인, 오피오이드, 니코틴 및 알코올을 포함한 다양한 중독 모델에서 유망한 결과를 보여주며, 갈망과 재발을 모두 줄이고 있습니다. 이전의 1상 시험에서는 하루 한 번 복용을 지원하는 안전성과 약리학적 특성이 긍정적으로 나타났습니다. 약 130만 명의 미국인이 CUD에 영향을 받고 있으며, 2022년에는 27,000명이 넘는 코카인 관련 사망자가 발생했기에 OMS527은 CUD에 대한 승인된 치료제가 현재 없는 상황에서 중요한 의료적 필요를 해결하고자 합니다.
Omeros (OMER) a obtenu un engagement de financement de 4,02 millions de dollars de l'Institut national sur l'abus des drogues (NIDA) pour le développement clinique de OMS527, un inhibiteur oral de la phosphodiestérase 7 visant le trouble de l'usage de cocaïne (CUD).
Le financement a été déclenché par des études de sécurité sur les interactions médicamenteuses où OMS527 n'a montré aucune augmentation des effets néfastes de la cocaïne et a démontré des résultats bénéfiques chez des animaux ayant reçu de la cocaïne. La subvention soutiendra un essai clinique de Phase 1b pour évaluer la sécurité et l'efficacité d'OMS527, avec des données initiales attendues au quatrième trimestre 2025.
OMS527 a montré des résultats prometteurs dans des modèles animaux pour diverses dépendances, y compris la cocaïne, les opioïdes, la nicotine et l'alcool, réduisant à la fois le désir et les rechutes. Un essai de Phase 1 précédent a démontré une sécurité favorable et une pharmacocinétique soutenant une dose quotidienne unique. Avec environ 1,3 million d'Américains touchés par le CUD et plus de 27 000 décès liés à la cocaïne en 2022, OMS527 vise à répondre à un besoin médical significatif non satisfait, car il n'existe actuellement aucun traitement approuvé pour le CUD.
Omeros (OMER) hat eine Finanzierungszusage in Höhe von 4,02 Millionen Dollar vom National Institute on Drug Abuse (NIDA) für die klinische Entwicklung von OMS527, einem oralen Phosphodiesterase-7-Hemmer, der auf das Kokaingebrauchsstörung (CUD) abzielt, gesichert.
Die Finanzierung wurde durch erfolgreiche Sicherheitsstudien zu Arzneimittelwechselwirkungen ausgelöst, bei denen OMS527 keine Verstärkung der schädlichen Auswirkungen von Kokain zeigte und in Kokain-verabreichten Tieren vorteilhafte Ergebnisse erzielte. Der Zuschuss wird eine Phase 1b klinische Studie unterstützen, um die Sicherheit und Wirksamkeit von OMS527 zu bewerten, wobei erste Daten im vierten Quartal 2025 erwartet werden.
OMS527 hat vielversprechende Ergebnisse in Tiermodellen für verschiedene Süchte, einschließlich Kokain, Opioiden, Nikotin und Alkohol, gezeigt, indem es sowohl das Verlangen als auch Rückfälle reduzierte. Eine vorherige Phase-1-Studie zeigte eine günstige Sicherheit und Pharmakokinetik, die eine einmal tägliche Dosierung unterstützt. Mit etwa 1,3 Millionen Amerikanern, die von CUD betroffen sind, und über 27.000 kokainbedingten Todesfällen im Jahr 2022 zielt OMS527 darauf ab, einen erheblichen ungedeckten medizinischen Bedarf zu decken, da es derzeit keine zugelassenen Behandlungen für CUD gibt.
- Secured $4.02M NIDA funding for Phase 1b clinical trial
- Successful safety studies showing beneficial effects in cocaine-administered animals
- Previous Phase 1 trial demonstrated favorable safety profile and once-daily dosing potential
- Broad potential application across multiple addiction types (cocaine, opioids, nicotine, alcohol)
- Addresses large market with no current approved treatments for CUD
- Early-stage development (Phase 1b) with significant clinical trials still needed
- Dependent on government funding for development
- Clinical efficacy in humans yet to be demonstrated
Insights
Omeros securing
The grant was triggered by successful completion of required safety studies, indicating the program has cleared an important regulatory hurdle. For a company with a market cap of approximately
This development has strategic significance as Omeros is targeting an unmet medical need - there are no FDA-approved treatments for CUD, which affects approximately 1.3 million Americans. The broader substance use disorder market represents a massive opportunity, with an estimated 50 million Americans affected and societal costs exceeding
While still in early clinical development, the external validation from NIDA and the potential for expanded applications across other addiction disorders (opioids, nicotine, alcohol) and compulsive behaviors enhances the program's value proposition. The company's proprietary position on PDE7 inhibition for addiction provides intellectual property protection for this potential revenue stream.
The NIDA funding commitment to Omeros' OMS527 program represents meaningful clinical advancement for their lead PDE7 inhibitor. Beyond the financial aspect, the successful completion of drug interaction studies provides important safety data showing OMS527 doesn't enhance cocaine's detrimental effects - a critical requirement for advancing addiction therapeutics.
More impressive is the observation that OMS527 actually demonstrated protective effects against cocaine-induced adverse reactions at higher doses, decreasing convulsant-related activity in animal models. This suggests the compound isn't merely safe when co-administered with cocaine but potentially offers immediate harm reduction benefits.
From a mechanism perspective, Omeros' approach targeting PDE7 is scientifically sound. Their compounds modulate the brain's dopamine signaling - essential in addiction pathways - without suppressing the reward system. This differentiation addresses a significant limitation of current anti-addiction medications that often reduce treatment adherence due to their reward-suppressing effects.
The Phase 1b trial design as a randomized, double-blind, placebo-controlled study provides robust methodology. With favorable Phase 1 safety data already established and once-daily dosing potential, OMS527 has a reasonable clinical path forward. The broader potential across multiple addiction indications (cocaine, opioids, nicotine, alcohol) and compulsive disorders substantially increases the program's value proposition if the clinical data continues to support efficacy.
– Successful Completion of Animal Drug Interaction Studies Triggers Funding for Phase 1b Clinical Trial in Patients with CUD –
Cocaine use disorder is characterized by compulsive cocaine use despite devastating adverse consequences and the development of a dysphoric state associated with drug withdrawal, which can trigger relapse. Results from the NIDA-funded OMS527-cocaine interaction studies demonstrated that OMS527, when administered at two different doses in combination with cocaine, did not produce an additive or synergistic effect on the convulsive threshold of cocaine in rats or on the adverse cocaine-induced cardiovascular responses in non-human primates. Instead, the higher dose of OMS527 generally lessened the severity of effects noted following intravenous administration of cocaine, most notably decreasing convulsant-related activity following administration of cocaine. NIDA’s award announced today will fund Omeros’ randomized, single-dose, double-blind, parallel-group, inpatient Phase 1b program comparing the safety and efficacy of OMS527 to placebo in the treatment of adults with CUD.
“We appreciate NIDA’s continued confidence in and support of our PDE7 inhibitor program, particularly given the recent challenges facing government grant funding,” said Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer. “The results of the animal drug-drug interaction studies not only were clean but showed beneficial effects of OMS527 on cocaine-receiving animals. The NIDA-funded Phase 1b program in patients with CUD has been initiated and we are targeting preliminary data readout by year-end. The preclinical, clinical, and mechanistic data generated to date suggest that our PDE7 inhibitor program could be effective in treating a broad range of addictions and compulsions. Nearly 50 million Americans 12 years of age or older suffered from a substance use disorder in 2022, resulting in estimated societal costs in excess of
Omeros discovered the role of PDE7 in addiction and compulsion and elucidated the associated mechanism of action of PDE7 inhibition. OMS527 and Omeros’ other potent, selective, and proprietary PDE7 inhibitors, modulate signaling in the brain’s dopamine axis – central to all addiction and compulsive disorders – without depressing the reward system, a major drawback of marketed anti-addiction agents. In animal models of addiction across cocaine, opioids, nicotine and alcohol, Omeros’ PDE7 inhibitors have been shown to reduce both craving and relapse as well as demonstrating benefit in a well-established animal model of binge eating. In a phase 1 clinical trial, OMS527 was well tolerated with no safety signal of concern and displayed favorable pharmacokinetics, supporting once daily dosing in the dose range expected to produce efficacy in humans. Omeros is developing OMS527 for the treatment of CUD at NIDA’s direct request.
An estimated 1.3 million people in the
Research reported in this press release was supported by the National Institute on Drug Abuse of the National Institutes of Health under award number U01DA058541. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
About Omeros Corporation
Omeros is an innovative biopharmaceutical company committed to discovering, developing and commercializing first-in-class small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders, including complement-mediated diseases and cancers, as well as addictive and compulsive disorders. Omeros’ lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application pending before FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Omeros’ long-acting MASP-2 inhibitor OMS1029 has successfully completed Phase 1 single- and multiple-ascending dose clinical studies. Zaltenibart, Omeros’ inhibitor of MASP-3, the key activator of the alternative pathway of complement, is advancing toward Phase 3 clinical trials for paroxysmal nocturnal hemoglobinuria and complement 3 glomerulopathy. Funded by the National Institute on Drug Abuse, Omeros’ lead phosphodiesterase 7 inhibitor OMS527 is in clinical development for the treatment of cocaine use disorder. Omeros also is advancing a broad portfolio of novel cellular and molecular immuno-oncology programs. For more information about Omeros and its programs, visit www.omeros.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the “safe harbor” created by those sections for such statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “likely,” “look forward to,” “may,” “objective,” “plan,” “potential,” “predict,” “project,” “should,” “slate,” “target,” “will,” “would” and similar expressions and variations thereof. Forward-looking statements, including statements regarding anticipated safety and therapeutic benefits of Omeros’ drug candidates and the availability of data from clinical trials are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. Omeros’ actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, changes in
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Jennifer Cook Williams
Cook Williams Communications, Inc.
Investor and Media Relations
IR@omeros.com
Source: Omeros Corporation
FAQ
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