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)--Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company, today announced positive topline results from its ALLEVIATE-1 pivotal Phase 3 clinical trial evaluating cebranopadol, an investigational therapy, for the treatment of moderate-to-severe acute pain in patients following abdominoplasty surgery.

)--商业阶段的生物制药公司Tris Pharma，Inc.（Tris）今天宣布，其缓解-1关键性3期临床试验的阳性结果，该试验评估了cebranopadol（一种研究性疗法），用于治疗腹部成形术后患者的中度至重度急性疼痛。

These results add to the growing body of data underscoring the promising efficacy and safety profile of cebranopadol, a first-in-class pain therapy involving dual-nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor (dual-NMR) agonism. This dual-NMR agonist has the potential to deliver significant pain relief comparable to opioids with minimized risk of significant side effects, dependence and addiction by leveraging the body’s pain biology modulation processes, synergizing the analgesic and safety characteristics of the NOP receptor with the analgesic advantages of the MOP receptor..

这些结果增加了越来越多的数据，强调了cebranopadol的有希望的疗效和安全性，cebranopadol是一种一流的疼痛疗法，涉及双重伤害感受蛋白/孤儿素FQ肽（NOP）受体和μ-阿片肽（MOP）受体（双重NMR）激动剂。这种双重NMR激动剂有可能通过利用身体的疼痛生物学调节过程，协同NOP受体的镇痛和安全特性以及MOP受体的镇痛优势，提供与阿片类药物相当的显着疼痛缓解，同时将显着副作用，依赖性和成瘾的风险降至最低。。

The results of the clinical study demonstrated a statistically significant reduction in pain intensity as measured using the Pain Numeric Rating Scale (NRS) Area Under the Curve for the 44 hours following surgery (AUC4-48) as the primary endpoint. Specifically, treatment with cebranopadol 400 µg once per day for two days resulted in a statistically significant reduction in pain intensity compared to placebo (LS Mean difference [SE] of 59.2 [14.36]; p<0.001).

。具体而言，与安慰剂相比，每天一次服用400µg cebranopadol治疗两天，疼痛强度在统计学上显着降低（LS平均差异[SE]为59.2[14.36]；p＜0.001）。

Additionally, cebranopadol was generally well tolerated and exhibited a favorable safety profile that was comparable to placebo, with no serious adverse events related to cebranopadol. The most common adverse event was nausea..

此外，cebranopadol通常耐受性良好，并且表现出与安慰剂相当的良好安全性，没有与cebranopadol相关的严重不良事件。最常见的不良事件是恶心。。

“These are extremely encouraging results, emphasizing the important role cebranopadol could play in effectively and safely alleviating moderate-to-severe acute pain for patients,” said Harold Minkowitz, M.D., primary investigator in the ALLEVIATE-1 study and president of analgesics, perioperative & hospital-based research at Evolution Research Group.

Evolution research Group的主要研究者兼镇痛药、围手术期和医院研究总裁哈罗德·明科维茨（HaroldMinkowitz）医学博士说：“这些结果非常令人鼓舞，强调了cebranopadol在有效和安全地缓解患者中重度急性疼痛方面的重要作用。”。

“Our team was impressed by the magnitude of analgesia seen, suggesting that cebranopadol’s novel mechanism of dual-NMR agonism has the potential to be as effective as opioids in the post-surgical setting. This analgesic efficacy, combined with evidence from prior clinical studies showing low drug likability and potential for fewer respiratory events, demonstrate that cebranopadol could help address a critical unmet medical need for the millions of people who experience acute pain.”.

“我们的团队对所观察到的镇痛效果印象深刻，这表明cebranopadol的双重NMR激动作用的新机制有可能在手术后环境中与阿片类药物一样有效。这种镇痛效果，再加上先前临床研究的证据显示，药物的亲和力低，呼吸事件少，表明cebranopadol可以帮助解决数百万急性疼痛患者的严重未满足的医疗需求。”。

“We are excited by the results from the ALLEVIATE-1 trial demonstrating a strong level of pain relief,” said Ketan Mehta, founder and chief executive officer at Tris Pharma. “The opioid crisis has highlighted the urgent need for pain management options that treat moderate-to-severe pain as effectively as opioids but do not carry similar risk of addiction and detrimental side effects.

Tris Pharma创始人兼首席执行官科坦·梅塔（KetanMehta）表示：“我们对缓解-1试验的结果感到兴奋，该试验显示出强烈的疼痛缓解水平。”。“阿片类药物危机突显出迫切需要疼痛管理选项，这些选项可以像阿片类药物一样有效地治疗中度至重度疼痛，但不会带来类似的成瘾风险和有害副作用。

We believe cebranopadol has the potential to transform the treatment landscape for patients suffering from acute pain.”.

我们相信，cebranopadol有可能改变急性疼痛患者的治疗格局。”。

Tris plans to submit full results from the ALLEVIATE-1 abdominoplasty clinical trial for presentation at an upcoming medical congress. In Q1 2025, Tris also plans to share results evaluating cebranopadol in two additional studies, an intranasal human abuse potential study and ALLEVIATE-2, a Phase 3 clinical study in patients following bunionectomy, with an NDA submission expected later this year.

Tris计划在即将举行的医学大会上提交EASLIVE-1腹部成形术临床试验的全部结果。2025年第1季度，Tris还计划在另外两项研究中分享对cebranopadol的评估结果，这是一项鼻内人类滥用潜力研究，也是一项针对布尼酮切除术后患者的3期临床研究，预计今年晚些时候将提交NDA。

Tris plans to conduct cebranopadol studies in multiple chronic pain indications beginning in the second half of 2025..

Tris计划从2025年下半年开始对多种慢性疼痛适应症进行cebranopadol研究。。

About ALLEVIATE-1

关于缓解-1

The ALLEVIATE-1 clinical trial (NCT06545097) is a Phase 3 multicenter, randomized, double-blind, placebo-controlled study. The primary objective of ALLEVIATE-1 is to evaluate the analgesic efficacy of cebranopadol compared with placebo for the management of moderate-to-severe acute pain following full abdominoplasty as measured by pain intensity (11-point numeric rating scale) assessments.

缓解-1临床试验（NCT06545097）是一项3期多中心，随机，双盲，安慰剂对照研究。ASEAVE-1的主要目的是评估cebranopadol与安慰剂相比对完全腹部成形术后中度至重度急性疼痛的镇痛效果，如通过疼痛强度（11点数字评定量表）评估所测量的。

Secondary objectives include assessing the analgesic efficacy of cebranopadol through use of rescue medication, early discontinuations and subject overall assessment of study medication..

次要目标包括通过使用救援药物，早期停药和研究药物的受试者总体评估来评估cebranopadol的镇痛效果。。

About Cebranopadol (TRN-228)

关于塞布拉诺帕多尔 (TRN-228)

Cebranopadol is a first-in-class investigational therapy that targets two key receptors, the nociceptin/orphanin FQ peptide (NOP) and µ-opioid peptide (MOP) receptors (a dual NMR agonist), for the treatment of moderate-to-severe pain, as well as opioid use disorder (OUD). These receptors are partially homologous to each other, and they play both complementary and distinct roles to modulate pain biology pathways.

Cebranopadol是一种一流的研究疗法，针对两种关键受体，即伤害感受蛋白/孤儿素FQ肽（NOP）和μ-阿片肽（MOP）受体（双重NMR激动剂），用于治疗中度至重度疼痛，以及阿片类药物使用障碍（OUD）。这些受体彼此部分同源，并且它们在调节疼痛生物学途径方面起着互补和独特的作用。

Studied in over 32 clinical trials in over 2,200 patients, cebranopadol’s profile has been well-characterized in pain management studies. It has demonstrated positive clinical results in acute pain, chronic pain and diabetic neuropathic pain with a favorable safety profile. The FDA granted Fast Track Designation to cebranopadol for chronic low back pain, and if approved, it could become the first dual-NMR pain-relief therapy with the demonstrated ability to provide efficacy equivalent to opioids with less potential for misuse or risk of physical dependence, addiction or overdose..

在2200多名患者的32项临床试验中进行了研究，cebranopadol的特征在疼痛管理研究中得到了很好的表征。它在急性疼痛，慢性疼痛和糖尿病神经性疼痛方面表现出积极的临床结果，具有良好的安全性。美国食品和药物管理局（FDA）批准了cebranopadol治疗慢性腰痛的快速通道，如果获得批准，它可能成为第一种双重核磁共振止痛疗法，具有与阿片类药物相当的疗效，但滥用或身体依赖、成瘾或过量风险较小。。

Cebranopadol’s novel mechanism of action has potential in treating patients with substance use disorders. Tris plans to continue to evaluate cebranopadol’s potential to help patients break the cycle of opioid addiction. The National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), has awarded Tris a five-year grant of up to $16.6 million to study cebranopadol’s potential to treat OUDs and SUDs..

Cebranopadol的新型作用机制在治疗药物使用障碍患者方面具有潜力。Tris计划继续评估cebranopadol帮助患者打破阿片类药物成瘾循环的潜力。美国国立卫生研究院（NIH）下属的国家药物滥用研究所（NIDA）授予Tris一笔为期五年的高达1660万美元的赠款，用于研究cebranopadol治疗OUD和SUD的潜力。。

About Tris Pharma

关于Tris Pharma

Tris Pharma is a privately held, innovation-driven biopharmaceutical company that is applying its drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain, addiction and disorders of the central nervous system. Tris is an established commercial organization with a robust portfolio of best-in-class ADHD products and a promising pipeline of differentiated, near-term drug candidates.

Tris Pharma是一家私营、创新驱动的生物制药公司，正在应用其药物开发能力和专有技术来改变多动症、疼痛、成瘾和中枢神经系统疾病的治疗方法。Tris是一家成熟的商业组织，拥有一流的ADHD产品的强大组合，以及有前途的差异化近期候选药物渠道。

More information is available at .

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www.trispharma.com

www.trispharma.com

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TrisPharma

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