Abaloparatide

Highlights include pooled safety findings from Paratek’s Phase 3 studies in community acquired pneumonia (CABP) and acute bacterial skin and skin structure infection (ABSSSI), as well as additional clinical and non-clinical data from Company- and investigator-sponsored studies KING OF PRUSSIA, Pa., April 16, 2026 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc., a privately held pharmaceutical company focused on high-need, targeted therapeutic areas, today announced that new data from scientific and investigator-initiated studies of NUZYRA ® (omadacycline) will be presented at ESCMID Global 2026, the annual Congress of the European Society of Clinical Microbiology and Infectious Diseases, taking place in Munich, Germany, April 17-21. “At this month’s ESCMID conference, we will present the most comprehensive safety review to date for NUZYRA in both pneumonia and skin infections, based on data from four Phase 3 trials in more than 1,400 patients,” said Randy Brenner, Chief Development and Regulatory Officer of Paratek. “In addition, we will have a poster of pivotal data from our rabbit study under the Animal Rule product development program, which we expect will help support a future sNDA submission for NUZYRA for the treatment of pulmonary anthrax. We are also pleased to continue to support high-caliber investigator-sponsored research, as will be presented at this week’s meeting.” ESCMID Poster Sessions Poster Title: An Integrated Safety Analysis of Omadacycline in Pivotal Phase 3 Clinical Trials Session: 05e. Safety, hypersensitivity and adverse effects of treatment Presenter: Maria Amodio-Groton, PharmD (Paratek research) Session Date, Time: Sunday, Apr. 19, 12:00 p.m. – 1:30 p.m. CEST (6:00 a.m. – 7:30 a.m. U.S. EDT) Location: Messe München Poster Hall B3 Poster ID: P3082 (The study has been supported in whole or part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under contract number 75A50120C00001.) (The safety analysis integrates data from Paratek’s four Phase 3 studies: two ABSSSI studies (OASIS-1, OASIS-2) and two CABP studies (OPTIC, OPTIC-2). Safety and efficacy data from the OPTIC-2 study were published in December 2025 in eClinicalMedicine , a Lancet Discovery Science journal, .) Poster Title: Omadacycline Demonstrated Efficacy as Therapeutic Treatment against Inhalation Anthrax in a Blinded, Randomized, Pivotal Study in New Zealand White Rabbits Session: 09b. Host-pathogen interaction (incl basic microbiome studies, animal models) Presenter: Alisa Serio, Ph.D. (Paratek research) Session Date, Time: Monday, Apr. 20, 12:00 p.m. – 1:30 p.m. CEST (6:00 a.m. – 7:30 a.m. U.S. EDT) Location: Messe München Poster Hall B3 Poster ID: P3998 (The anthrax-related project has been supported in whole or part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under contract number 75A50120C00001.) Poster Title: Efficacy and Safety of Omadacycline Oral Step-Down Therapy Following Bloodstream Infection: A Real-World Descriptive Study Session: 05c. New or repurposed antibacterial agents: Clinical studies and randomised trials Presenter: Sean Van Helden, PharmD (Investigator-initiated research) Session Date, Time: Sunday, Apr. 19, 12:00 p.m. – 1:30 p.m. CEST (6:00 a.m. – 7:30 a.m. U.S. EDT) Location: Messe München Poster Hall B3 Poster ID P2881 About Paratek Pharmaceuticals, Inc. Paratek Pharmaceuticals, Inc. is a specialty pharmaceutical company with a portfolio of differentiated medicines serving patients across multiple therapeutic areas. The company integrates and advances commercial-stage assets through disciplined commercial execution, lifecycle management, and clinical development initiatives designed to expand and strengthen its portfolio. Paratek's products include NUZYRA ® (omadacycline), XHANCE ® (fluticasone propionate), and TYMLOS ® (abaloparatide). Paratek is privately held by B-FLEXION Life Sciences. In December 2019, BARDA awarded Paratek a PBS contract (75A50120C00001) that is now valued at up to approximately $304 million. In addition to supporting the development of NUZYRA for both the treatment and prophylaxis of pulmonary anthrax, this contract supports the U.S. onshoring of NUZYRA and manufacturing security requirements; FDA post-marketing requirements associated with the initial NUZYRA approval; and the procurement of up to 10,000 treatment courses of NUZYRA for the treatment of anthrax. For more information, visit or follow us on LinkedIn and X . About NUZYRA NUZYRA (omadacycline) is an antibiotic with both once-daily oral and intravenous (IV) formulations indicated for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible microorganisms. A next-generation tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypical, and other drug-resistant strains. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS NUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline class antibacterial drugs, or to any of the excipients. WARNINGS AND PRECAUTIONS Mortality imbalance was observed in the CABP clinical trial, with eight deaths (2%) occurring in patients treated with NUZYRA compared to four deaths (1%) in patients treated with moxifloxacin. The cause of the mortality imbalance has not been established. All deaths, in both treatment arms, occurred in patients >65 years of age; most patients had multiple comorbidities. The causes of death varied and included worsening and/or complications of infection and underlying conditions. Closely monitor clinical response to therapy in CABP patients, particularly in those at higher risk for mortality. The use of NUZYRA during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia. The use of NUZYRA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth. Hypersensitivity reactions have been reported with NUZYRA. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with other tetracycline class antibacterial drugs. NUZYRA is structurally similar to other tetracycline class antibacterial drugs and is contraindicated in patients with known hypersensitivity to tetracycline class antibacterial drugs. Discontinue NUZYRA if an allergic reaction occurs. Clostridioides difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. NUZYRA is structurally similar to tetracycline class antibacterial drugs and may have similar adverse reactions. Adverse reactions, including photosensitivity, fixed drug eruption, pseudotumor cerebri, and anti-anabolic action (which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests), have been reported for other tetracycline class antibacterial drugs, and may occur with NUZYRA. Discontinue NUZYRA if any of these adverse reactions are suspected. Prescribing NUZYRA in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. ADVERSE REACTIONS The most common adverse reactions (incidence ≥2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia, and constipation. DRUG INTERACTIONS Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while taking NUZYRA. Absorption of tetracyclines, including NUZYRA, is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate, and iron-containing preparations. USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding is not recommended during treatment with NUZYRA. See full prescribing information here . MEDIA CONTACT: Adam Silverstein adam@scientpr.com

骨质疏松是个严峻的话题。面对严重骨质疏松或亟需提升骨强度的患者，如何最快、最有效地“重建地基”？ 目前，促成骨药物领域正经历着从“单点突破”到“多靶点协同”的深刻演变。今天，我们就沿着促成骨药物的“临床选择”与“未来格局”这条主线，深度盘点当前核心药物的场景应用，并前瞻抗骨质疏松治疗的终极图景。 促成骨机制示意图一、 当下的选择：三大促成骨药物的临床场景匹配 现阶段的促成骨药物并没有所谓的“绝对之王”，核心在于：根据患者的近期骨折风险与具体部位需求，进行精准的兵力部署。 1. 罗莫索单抗（Romosozumab）：极高危与近期风险的首选“重火力” 机制与优势： 作为抗硬化蛋白单抗，它拥有独特的“双向机制”——既能促进骨形成，又能抑制骨吸收。这是目前起效最快、提升髋部骨密度（BMD）最强的一线强药，能够以极高的效率压低近期椎体与非椎体骨折风险。 局限与防线： 它的促成骨效应在12个月后会减弱，因此疗程受限；同时自带心血管风险警示，过去1年内有心梗或卒中史的患者应避免使用。 2. 阿巴洛肽（Abaloparatide）：PTH通路的“临床优化版” 机制与优势： 这款PTHrP(1-34)类似物在真实世界中表现十分亮眼。相比于传统老将特立帕肽，它对总髋和股骨颈的骨密度增益更大，高钙血症的发生率更低，且在降低非椎体和髋部骨折发生率上展现出更优的数据。 3. 特立帕肽（Teriparatide）：成熟可靠的“老将” 机制与优势： 作为最早进入临床的PTH(1-34)药物，它的优势在于极高的确定性。证据链条最完整，临床使用经验最丰富，适用面极广，全面覆盖绝经后、男性及糖皮质激素相关的骨质疏松。 相对局限： 提升髋部/皮质骨骨密度的速度与幅度，相对不及前两位“后起之秀”。二、 治疗的基石：“序贯”理念贯穿始末 在抗骨松的战役中，促成骨药物的收益是极其宝贵但具有时效性的。当前全球指南与共识高度一致的核心逻辑只有八个字：先促成骨，后抗吸收。 无论罗莫索单抗的12个月疗程结束，还是PTH类药物停药，都必须无缝衔接双膦酸盐或地舒单抗等抗吸收药物。 这一战略能够将患者推入更安全的骨密度区间，最大化地保留并巩固前期辛辛苦苦建立起来的骨量与骨强度。尤其是在维持总髋骨密度这一与长期骨折风险高度相关的指标上，“序贯”是决定最终胜负的关键。三、 未来的演进：四大研发趋势打破天花板 未来的抗骨松新药研发，已经不再局限于单纯盯着“腰椎骨密度”这一个数字，而是向着多维度的真实临床获益全面拓展： 给药途径变革（注射走向口服）： 以EB613（口服PTH(1-34)）为代表的项目（殊途同归？口服特立帕肽的“路线之争”：EB613 vs. RaniPill，EB613会成为骨质疏松治疗模式的革新者吗？），有望彻底打破患者依从性的壁垒，让促成骨治疗从少数高危人群的“被动选择”，变为更广大患者群体的“早期干预方案”。 Wnt通路的持续深耕： 罗莫索单抗在前方验证了Wnt轴的巨大临床价值，后续如SHR-1222等新型抗硬化蛋白单抗正排队入场，寻找更安全、更稳定、更具性价比的分子结构。 多靶点协同发力（DKK1 + Sclerostin）： 基础研究发现，单独抑制Sclerostin后，DKK1会产生代偿性升高，导致后期成骨效应钝化。双靶点联合抑制，正成为突破成骨上限的全新解法。 评价维度的全面立体化： 研发的成功指标从单一的腰椎BMD，全面转向总髋/股骨颈骨密度的提升、皮质骨微结构的改善，以及早期骨转换标志物的精准预测。四、 深度聚焦：双靶点先锋 AGA2115 与 AGA2118 在多靶点协同的浪潮中，AGA2115与AGA2118这两款药物代表了“DKK1 + Sclerostin”双特异性抗体路线在人体临床的实质性破局，但二者的战略定位截然不同。 AGA2115：骨质量与罕见脆骨病的“概念验证器” 主攻方向： 它优先跳出了普通骨松的限制，布局成骨不全（OI）这一罕见病。除了看密度，更重点评估骨微结构、骨活检与真实脆性的改善。 核心数据与意义： 健康志愿者数据显示，极高剂量下6个月腰椎BMD增加可达14.4%，总髋增加3.6%。它的使命是验证双靶点调控在解决“骨质量极差”难题上的终极潜力。 AGA2118：大众骨质疏松市场的“下一代主力” 主攻方向： 直指绝经后骨质疏松这一主战场，目前已推进至ARTEMIS II期临床。 核心数据与意义： 早期I期数据显示，6个月腰椎BMD增加11.5%，总髋增加5.3%。这个极具潜力的髋部增益信号是其突围关键。未来它能否真正挑战罗莫索单抗的霸主地位，取决于其在II期临床中能否证明：总髋增益持续领先、成骨信号衰减更慢，且无新型副作用。 编者按： 强力的双靶点机制可能带来组织选择性的隐患。前临床研究曾提示双重抑制可能引发颅骨改变，这类非目标骨区的长期安全性，必将是未来研发和监管审查的重中之重。结语： 回顾从抗吸收时代到促成骨时代的跨越，未来的骨质疏松诊疗绝不会是“一药走天下”，而是会演变成一个高度结构化、精细化的新生态： 诊疗逻辑的升维： 从单纯的“抑制骨量流失”全面转向主动的“重建骨骼结构”；从“单点药物干预”走向复杂的“多靶点通路编排”。 临床路径的定型：风险分层 + 目标导向 + 多靶点促成骨起始强化 + 强效抗吸收维持 + 便捷化给药，将成为未来十年的标准范式。 核心竞争的转移： 新药开发的胜负手，不再仅仅比拼腰椎数据的绝对值，而是聚焦于总髋骨密度提升力、长期安全性的边界，以及真实世界中患者的治疗依从性。 骨骼重建，是一场与时间赛跑的持久战。精准的药物选择与前瞻的视野，方能为患者打下最坚实的预后基础。