Longwood Management Inc

7月22日，圣地亚哥，Crystalys Therapeutics，一家临床阶段的生物制药公司，致力于解决痛风患者严重未满足的医疗需求，宣布完成1.3亿美元的超额认购B轮融资，以支持dotinurad的后期全球临床开发和商业化，这是一种新一代每日一次的口服URAT1抑制剂，有可能为痛风治疗提供一流的安全性和疗效。融资由Frazier Life Sciences领投，Wellington Management、HBM Healthcare Investments、Soleus Capital、Cormorant Asset Management、Trails Edge Capital Partners、Pivotal bioVenture Partners和KCap Biotechnology Fund以及所有现有投资者Novo Holdings、SR One、Catalys-Pacific、Perceptive Xontogeny Venture Funds、Lightstone Ventures、AN Venture Partners、abrdn管理的基金、KB Investments、Pontifax、Longwood Fund、Alexandria Venture Investments、Wedbush Healthcare Partners和Prebys Ventures Fund。2024年7月Crystalys Therapeutics从Fortress Biotech控股子公司Urica Therapeutics引进dotinurad的知识产权和许可协议。 2025年10月Crystalys Therapeutics宣布正式推出并完成2.05亿美元的A轮融资。（新锐！2.05亿美元A轮融资，开发痛风新药） Dotinurad的临床开发计划包括两项正在进行的3期注册指导试验RUBY和TOPAZ，以及正在进行的2期AMETHYST研究，这些试验共同旨在评估Dotinurat对广泛痛风患者的影响，包括那些治疗选择有限的患者。预计融资所得将支持dotinurad的持续临床开发、商业化准备活动，并通过多个预期的临床和监管里程碑提供运营跑道。 Crystalys Therapeutics总裁兼首席执行官James Mackay博士表示：“在我们推进dotinurad进入后期临床开发和商业化准备的过程中，我们很高兴得到这个强大的新投资者联盟和所有现有投资者的支持。这笔融资加强了我们推进RUBY、TOPAZ和AMETHYST研究的能力，并使Crystalys能够实现多个重要的临床和监管里程碑以及商业准备，因为我们致力于为痛风患者带来潜在的最佳治疗选择。” Frazier Life Sciences合伙人Kevin Li表示：“随着Crystalys公司继续推进dotinurad，我们很高兴在这个重要的增长阶段为其提供支持。在经验丰富的领导团队的支持下，该公司围绕一项后期资产建立了坚实的基础，有可能解决痛风中尚未满足的重大需求。我们相信Crystalys完全有能力为患者创造有意义的影响，也相信该公司有能力实现商业化。” Dotinurad（多替诺雷）由Fuji Yakuhin（日本富士药品）发明，已经在多项临床研究中证明了强大的疗效和明确的安全性，支持其已在日本、中国、菲律宾和泰国的批准。2024年12月，日本卫材宣布多替诺雷片（Dotinurad，商品名：优乐思®）已正式获得中国国家药品监督管理局（NMPA）的批准，用于治疗痛风伴高尿酸血症患者。多替诺雷是一种高选择性的尿酸盐转运蛋白1（URAT1）抑制剂，通过有效抑制肾近端小管URAT1的功能，促进尿酸从肾脏排泄，从而降低血尿酸水平。 关注下方公众号，带你看世界!

Less than a year after emerging from stealth, Crystalys Therapeutics has bagged a $130-million series B led by Frazier Life Sciences to carry its gout candidate over the clinical finish line and prepare for its potential commercialisation. New investors Wellington Management, HBM Healthcare Investments, Soleus Capital, Cormorant Asset Management, Trails Edge Capital Partners, Pivotal bioVenture Partners and KCap Biotechnology Fund also participated in the financing, as did all existing backers including Novo Holdings, SR One, Catalys Pacific, Perceptive Xontogeny Venture Funds, Lightstone Ventures, AN Venture Partners, funds managed by abrdn, KB Investments, Pontifax, Longwood Fund, Alexandria Venture Investments, Wedbush Healthcare Partners and Prebys Ventures Fund.Filling the gout treatment gapCrystalys is studying dotinurad, a once-daily, oral URAT1 inhibitor, in the Phase III RUBY trial involving 500 adults with hyperuricemia associated with gout, and in the Phase III TOPAZ trial of about 250 adults with tophaceous gout. The two studies, expected to finish in late 2027 per ClinicalTrials.gov, are comparing dotinurad against the xanthine oxidase inhibitor allopurinol, a standard first-line treatment for gout that lowers the body's production of uric acid. According to the biotech, there are few treatment options for patients with chronic gout who don't respond to first-line treatments. Amgen's intravenous Krystexxa (pegloticase) can be given to patients with severe gout as a last-line option, but the therapy can cause nausea, vomiting and infusion reactions; it also carries a boxed warning for severe allergic reactions. By blocking URAT1, a key urate transporter involved in renal uric acid reabsorption and excretion, dotinurad is designed to increase uric acid excretion by the kidney. Crystalys believes it has the potential to serve as a second-line oral treatment option for patients who don't respond to allopurinol, "addressing a significant treatment gap between xanthine oxidase inhibitors and intravenous uricase."Wednesday's financing, which adds to its $205-million series A raised last year, is expected to support the RUBY and TOPAZ studies, along with the Phase II AMETHYST study testing dotinurad in patients who are intolerant to xanthine oxidase inhibitors or failed uricase treatment, and provide sufficient runway for Crystalys to hit several clinical and regulatory milestones. However, even if dotinurad is successfully greenlit by the FDA for gout, it may hit shelves behind a rival product from Swedish Orphan Biovitrum (Sobi). The drugmaker in December agreed to spend $950 million upfront to buy Arthrosi Therapeutics and its once-daily oral URAT1 inhibitor, pozdeutinurad. A pivotal readout from the Phase III REDUCE 1 trial evaluating pozdeutinurad in patients with gout is expected this half, while the REDUCE 2 trial in May met its primary efficacy endpoint in adults inadequately controlled or uncontrolled gout.

After Rallybio was left hanging by Candid Therapeutics — who got bought up by UCB for $2 billion, instead of going public as planned in a reverse merger with its fellow biotech — the drugmaker has found a new M&A partner. Rallybio has set its sights on a merger with Avenzo Therapeutics, prompting its shares to climb about 15% on Monday. While the exact share exchange ratio will be determined closer to the deal close, expected in the fourth quarter, the combined company will operate under the Avenzo name, be led by Avenzo CEO Athena Countouriotis, and list on NASDAQ under the ticker "AVZO."Alongside the merger, Avenzo is raising a $215-million private placement from a slew of investors including Blackstone, Vivo Capital, Affinity Asset Advisors, ADAR1 Capital Management, OrbiMed, SR One, Foresite Capital, Surveyor Capital, Longwood Fund, New Enterprise Associates, Deep Track Capital, Sands Capital, Lilly Asia Ventures and Sofinnova Investments, among others. Between the financing and both drugmakers' existing cash balance, the combined company is expected to have runway into late 2028 and sufficient funds to support development of Avenzo's four clinical programmes, in-licensed from three Chinese biotechs, and the launch of multiple Phase II studies (see – Spotlight On: China biotech's NewCo model takes centre stage).Avenzo has partnered with Allorion Therapeutics for rights to CDK2 inhibitor AVZO-021 and CDK4 inhibitor AVZO-023; gained an EGFR/HER3 bispecific antibody-drug conjugate (ADC), AVZO-1418, from Duality Bio; and licensed a Nectin4/TROP2 bispecific ADC, AVZO-103, from VelaVigo.AVZO-021 is being studied in two Phase I trials involving patients with HR-positive, HER2-negative breast cancer. In the first, it's being dosed alongside fulvestrant, and in the second, the CDK2 inhibitor is given in combination with AVZO-023.The Phase I/II AVENTINE-1 trial is evaluating AVZO-1418 in patients with solid tumours, and the Phase I/II BEACON-1 study is assessing AVZO-103 monotherapy in multiple tumor types, including urothelial cancer. Updated data from AVENTINE-1 and an initial readout from BEACON-1 are due later this year.