Tralokinumab

Dermatology specialist Leo Pharma has struck a transfer deal with Boehringer Ingelheim, paying 90 million euros ($105 million) up front for rare disease drug Spevigo, which was approved in 2022. For the second time this year, Leo Pharma has struck a partnership with a major drugmaker, this time paying Boehringer Ingelheim 90 million euros ($105 million) up front for the rare disease drug Spevigo.Specializing in dermatology, Denmark-based Leo is well equipped to take control of Spevigo, which treats flares that accompany generalized pustular psoriasis (GPP), a skin condition so debilitating that it can become fatal.With the transfer agreement, Leo will take responsibility for the development and commercialization of Spevigo around the world. The companies, which are both private, did not reveal full terms of the agreement, though we do know Leo is on the hook for undisclosed milestone and royalty payments.The transaction comes on top of Leo signing a $1.7 billion deal back in January with Gilead, in which it got $250 million up front for part of its STAT6 transcription factor program.In adding and subtracting assets, Leo is transforming its business, trying to zero in on what it does best.“Boehringer Ingelheim has picked us as the best owner of the asset,” Bourdon told Fierce Pharma. “Beyond the work they have done, which is tremendous, we can be a better owner through our medical market access, commercial, dermatology-focused expertise.” Spevigo was approved in 2022 and gained a label expansion last year to treat patients as young as age 12. It is currently available in more than 40 countries and can be used to both treat flare-ups and to prevent them, with injections every four weeks.The selective antibody, which blocks the activation of the IL-36 signaling pathway, is the first targeted therapy for the treatment of GPP. While sales figures are not available, Bourdon said that Spevigo has the potential to become “one of our largest products.”“(Boehringer) has built this medical, commercial footprint globally but they also realized that we at Leo do only one thing, which is to interact with dermatologists,” Bourdon said. “We came up with a plan where they were confident that we could create more value with the asset.”Spevigo is under investigation in a pivotal phase 3 trial in another rare autoimmune skin condition, pyoderma gangrenosum (PG), which causes painful ulcers.“It fits nicely to where we want to go—high unmet need, no available treatment and a transformative treatment that can really help patients,” Leo’s Chief Scientific Officer Pontoppidan Thyssen, Ph.D., added in the interview. “It’s worth a shot on goal.” One shot on goal that was off the mark was Leo’s 2023 buyout of Timber Pharmaceuticals and its late-stage candidate for another rare dermatological condition for $14 million. In August of last year, the company revealed that the asset had flunked a phase 3 trial.Bourdon came to Leo three years ago when it was in dire financial straits and in need of a slim down. The company reduced its costs and adjusted its innovation model, pursuing external innovation as opposed to its long-held focus on internal R&D.For now, the company is depending on the growth of IL-13 eczema treatment Adbry, which was approved in 2021, and the progression of topical JAK inhibitor delgocitinib, which is under review by the FDA as a treatment for chronic hand eczema. In earlier-stage development are topical therapies that Leo is developing in its STAT6 program. In making its deal with Gilead in January, Leo held onto those candidates while the California company is placing a bet on its ability to develop oral STAT6 therapies for inflammatory diseases as an alternative to injectable biologics such as Regeneron and Sanofi’s Dupixent and AbbVie’s duo of Rinvoq and Skyrizi.“Three years ago, two years ago, when we talked about transforming the company, about inventing a new innovation model, I think it was a wild ambition,” Bourdon said. “And now in less than six months, we have Gilead knocking at your door, we have Boehringer knocking at your door.”

IL-31Rα（白细胞介素-31受体α）是IL-31的功能性受体亚基，与OSMRβ形成异源二聚体复合物，介导IL-31的信号传导，通过JAK/STAT、PI3K/AKT和MAPK-JNK/p38激活途径的磷酸化，引发炎症级联反应。参与炎症、瘙痒、细胞增殖等多种生物学过程，尤其在慢性瘙痒性疾病（如结节性痒疹、特应性皮炎）中起关键作用【1】。相较于同适应症的 IL-4 ，IL- 13 等靶点具有不同的作用机制。以 IL-4 、IL-5 、IL- 13 为代表的细胞因子抗体药物，包括 Dupilumab（IL-4Ra ，影响 IL-4 和 IL- 13 信号通路）、Tralokinumab（IL- 13 ，影响 IL- 13 信号通路），主要影响 Th2 型细胞因子介导的炎症反应，而对瘙痒信号的传递作用有限。 目前靶向IL-31Rα的药物非常稀缺，唯一一款获批上市的药物是Galderma公司的Nemolizumab(Nemluvio®)。Galderma获得该药物可以追溯到2016年，Galderma在2016从Chugai引进了Nemolizumab（Nemluvio®）除日本外的全球权益。2022 年 Nemolizumab 在日本批准上市，用于对常规 AD 治疗方法无效的特应性皮炎患者的治疗。2年后，Nemluvio®在美国获批，获批两个适应症分别是节性瘙痒症和特应性皮炎。IL-31Rα靶向药物也因此在临床上被验证。也为瘙痒性皮肤病提供了新的治疗选择。参考文献：【1】IL-31：炎症和治疗中的“瘙痒”细胞因子目前，药时代BD团队正在为一款具有快速止痒效果、更长给药周期（Q12W）的IL-31Rα抗体寻找潜在合作伙伴。项目简介项目代号：DT-20250620-057项目名称：一款兼具快速止痒效果和更长给药周期（Q12W）的IL-31Rα抗体适应症：中重度特应性皮炎、结节性痒疹、未明原因的瘙痒药物类型：单抗靶点：IL-31Rα产品阶段：PCC，预计2026Q1申报IND项目亮点：48小时内快速起效止痒，1周内瘙痒减轻30%（Dupilumab仅7%）与IL-4Rα单抗联用，可更早打破“痒-抓-痒”循环，提升整体疗效。半衰期长，支持每12周一次给药（Nemolizumab为每4周一次）。成本低、可及性高（30mg，每12周皮下注射一次）。合作需求：license-out（大中华区 or 除大中华区以外区域）如果贵公司对该项目感兴趣，欢迎立即联系药时代BD团队！点击这里，查看更多BD项目！