Ascentage Pharma’s Post

NEWS! 👉Johnson & Johnson (J&J) is buying the rights to a new eczema treatment from Numab Therapeutics AG for about $1.25 billion. 👉This is J&J's second purchase of an eczema-focused company this month. 👉They bought Proteologix earlier for $850 million. Numab's drug, NM26, has just passed early testing and targets two disease pathways at once. 👉Eczema, also known as atopic dermatitis, affects 30 million people each year in the U.S. J&J is focusing on medical devices and drugs, making big deals like buying Shockwave Medical for $13.1 billion. 👉They are preparing for competition for their psoriasis drug Stelara in 2025. The deal with Numab should be finalized in the second half of 2024. #acquisition #numabtherapeutics #Proteologix #eczema #NM26 #atopicdermatitis #Johnsonandjohnson #healthcare

Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) CEO James Graham joins Proactive’s Tylah Tully to discuss progress in a Phase II clinical trial for the topical gel RECCE® 327 (R327G). Recce has formally reached the halfway point, with 15 patients successfully dosed. The trial is assessing the efficacy of R327G against Acute Bacterial Skin and Skin Structure Infections (ABSSSI), including diabetic foot infections and other wound infections, which are areas of significant unmet medical need. Early data shows that R327G is well tolerated, with promising antibacterial effects observed across a range of infections. The trial aims to enrol 30 participants by the end of 2024. The clinical study locations have expanded, now including Barwon Health, Australian Clinical Research Network NSW and ACRN Melbourne, increasing access to this novel treatment. Watch at #Proactive #ProactiveInvestors #Biotech #Biopharmaceutcials #AntiInfectives #RCE http://ow.ly/ecPf105Lpil

Opthea Announces Placement and Partially Underwritten Entitlement Offer to Raise up to Approximately A$227.3 million (US$150.0 million) Opthea expects the net proceeds from the Placement and Entitlement Offer, together with cash on hand, to fund the Company, through the anticipated Phase 3 topline data readouts for COAST (Combination OPT-302 with Aflibercept Study), and ShORe (Study of OPT-302 in combination with Ranibizumab). The funds are also intended to be used to progress chemistry, manufacturing, and controls (CMC) activities, Biologics License Application (BLA) preparations for FDA approval, and for general corporate purposes. Based on the completion of enrollment in COAST in February 2024 and ShORe in May 2024, as well as Opthea’s internal expansion of its clinical development team, the topline data readout of COAST is now accelerated to early in the second calendar quarter of 2025, and the topline data readout for ShORe is anticipated in mid-calendar year 2025.   To read full press release: https://lnkd.in/eufQw4Ep #Opthea #maculardegeneration #AMDResearch #wetAMD #ophthalmology #medicaleducation #biopharma #eyehealth #retinaspecialists

LENZ Therapeutics plans to seek FDA approval for its investigational eye drops for #presbyopia, setting up the drug to compete against AbbVie’s #Vuity and Orasis Pharmaceuticals’ #Qlosi. The biopharma recently shared positive Phase 3 data for two formulations of the treatment, saying both met the study’s primary endpoint, though it plans to pursue an #NDA for the version that doesn’t include #brimonidine. In topline data from the CLARITY 1 and 2 trials, LENZ investigated two formulations of #aceclidine: LNZ100 and LNZ101, which contains brimonidine. In the CLARITY 2 trial, LNZ100 won out, with 71% of patients achieving three lines or greater improvement in eyesight after 30 minutes based on the Best Corrected Distance Visual Acuity test. LNZ100 hit the primary endpoint, with 71% of patients achieving three lines or greater improvement in eyesight after 3 hours. About 40% of patients who received that formulation achieved three lines or greater improvement after 10 hours. https://bit.ly/4cISDq9

Biosimilars for Regeneron’s aflibercept 2mg are coming to the US. The FDA has given two drugs, Yesafili (Biocon Biologics) and Opuviz (Biogen and Samsung Bioepis), the thumbs up with an interchangeability designation. The FDA has indicated that the drugs’ performance and safety profile were similar according to a battery of comparative measures, including clinical trials. The announcement and its impacts are now reverberating through the American anti-VEGF market for retinal diseases. What will the implications be for both patients and caregivers? https://lnkd.in/gg5sFUhW #antiVEGF #Biosimilars #MediaMICE

Delighted to announce the publication of a pre-print by the esteemed HESI Cardiac Safety Committee (https://lnkd.in/gMDu5VY) describing a new Cardiac Compound Tool Database! This new database (https://lnkd.in/gKYRrX3z) contains information on 128 pharmaceutical agents, including their cardiotoxic properties. Curated by subject matter experts and sourced from reputable literature and online databases, this resource provides details such as compound name, mode of action, cardiac toxicity profile, and more. The user-friendly interface allows for easy access and submission of new data, ensuring the database remains up-to-date and valuable for safety assessment and research on drug-induced cardiac toxicity. Read the full pre-print here: https://lnkd.in/gjR8dpAu

Xeris Pharmaceuticals® Medical Affairs is excited to share a clinical update with an upcoming Poster Presentation at #ENDO2024. Come and view our Poster (bit.ly/SAT-085) on June 1, 2024, Effects of Levoketoconazole on 24-hour Mean UFC (mUFC) in the SONICS Study: Relation to Baseline mUFC in Adults with Cushing’s Syndrome: a Post-hoc Analysis.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion concerning the authorization of Outlook Therapeutics, Inc.'s ONS-5010/#Lytenava (#bevacizumab gamma), an investigational #ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet #AMD) in the EU. If approved, an initial ten years of market exclusivity in the European Union is expected for ONS-5010/LYTENAV. https://bit.ly/3VtfnUY

Amylyx Pharmaceuticals' ALS drug, Relyvrio, didn't meet its goals in the crucial Phase III trial, casting uncertainty on its future. Despite this, the drug's safety profile remained consistent. Considerations - 🔹 The impact on ALS treatment advancements and patient hope. 🔹 Potential regulatory discussions and the commitment to patient well-being may guide Amylyx's next steps. This setback in ALS research emphasizes the challenges in neurodegenerative disease treatment but also the unwavering quest for solutions. #ALS #HealthcareNews #ClinicalTrials

Congratulations to Neuren Pharmaceuticals who have announced positive results from the Phase 2 clinical trial of NNZ-2591 for Pitt Hopkins Syndrome. A similar Phase 2 trial of NNZ-2591 is underway for PWS in the USA. Based on the good safety and tolerability profile of NNZ-2591 from the Phelan-McDermid and Pitt Hopkins Syndrome trials, Neuren believe that they “can and should” simplify the trial protocol for PWS. Although this means that the trial will be paused while FDA permission is sought, it suggests that Neuren are considering optimising the PWS trial Protocol to reduce the burdens associated with trial participation. You can read the full press release here: https://lnkd.in/e_TDMHvB... To watch the Video presentation of Neuren's latest trial at 26 minutes you can watch the discussion of pausing PWS trial. https://lnkd.in/eyxn4-hA #praderwillisyndromeawareness #pws #PWSresearch #research #praderwillisyndrome #PWSResearch #pwsresearch #PraderWilliResearchFoundationAus #clinicalresearch