Vial Announces Enrollment of First Patient in Phase II Clinical Trial TLL018-205 for the Treatment of Plaque Psoriasis Sponsored by Highlightll Pharmaceutical


Excerpt from the Press Release: SAN FRANCISCO, Jan. 19, 2023 /PRNewswire/ — Vial, a global tech-enabled CRO providing next-generation clinical trial management services, announced that the first patient has been enrolled in the clinical trial TLL018-205, a Phase II, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of TLL-018 in human subjects with moderate…

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Madrigal Announces Additional Positive Results from the Pivotal Phase 3 MAESTRO-NASH Clinical Trial of Resmetirom for the Treatment of NASH with Liver Fibrosis


As previously reported, resmetirom demonstrated improvements in NASH and liver fibrosis on liver biopsies, the primary endpoints of the MAESTRO-NASH trialA supportive analysis using consensus reads of digitized biopsy images by the central pathologists replicated the positive primary endpoint resultsThese data will be presented at the NASH-TAG Conference on Friday January 6th, 2023 Excerpt from…

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Sionna Therapeutics Announces Advancement of Cystic Fibrosis Pipeline Programs and Presentation at J.P. Morgan 41st Annual Healthcare Conference


– Enrolling Phase 1 study of lead NBD1 modulator, SION-638, following IND clearance from the FDA; data expected in the second half of 2023 – – SION-109, targeting complementary mechanism ICL4, on-track for IND submission in the first half of 2023 – – Three additional development candidates nominated for progression including two Series 2 NBD1…

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Alnylam Submits CTA Application for ALN-KHK, an Investigational RNAi Therapeutic for the Treatment of Type 2 Diabetes


–Company Expects to Initiate a Phase 1/2 Study for ALN-KHK in Early 2023, with Initial Results Expected in Late 2023 – Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi (RNA interference) therapeutics company, announced today that the Company has submitted a Clinical Trial Authorization (CTA) application to Health…

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Maze Therapeutics Announces Completion of Phase 1 First-in-Human Trial Evaluating MZE001 as a Potential Oral Treatment for Pompe Disease


MZE001 was Well-Tolerated and Reduced Glycogen Accumulation in Blood Cells in Healthy Volunteers, Supporting Advancement into Phase 2 Clinical Trial Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Maze Therapeutics, a company translating genetic insights into new precision medicines, today announced the completion of its first-in-human clinical trial designed to evaluate the safety, tolerability,…

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Rezolute Announces Initiation of a Phase 2 Study of RZ402 in Patients with Diabetic Macular Edema


RZ402 is an oral therapy being developed as a potential alternative to invasive and suboptimal injections into the eye Excerpt from the Press Release: REDWOOD CITY, Calif., Dec. 15, 2022 (GLOBE NEWSWIRE) — Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to shift the treatment paradigms of…

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Moderna and Merck Announce mRNA-4157/V940, an Investigational Personalized mRNA Cancer Vaccine, in Combination with KEYTRUDA(R) (pembrolizumab), Met Primary Efficacy Endpoint in Phase 2b KEYNOTE-942 Trial


mRNA-4157/V940, in combination with KEYTRUDA, demonstrated a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death compared to KEYTRUDA monotherapy in stage III/IV melanoma patients with high risk of recurrence following complete resection Results are the first demonstration of efficacy for an investigational mRNA cancer treatment in a randomized clinical…

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Corvus Pharmaceuticals Presents Updated Data from CPI-818 (ITK Inhibitor) Phase 1/1b Clinical Trial at the 64th American Society of Hematology (ASH) Annual Meeting & Exposition


Results in patients with refractory T cell lymphoma demonstrated CPI-818’s anti-tumor activity and effects on T cell differentiation which indicate therapeutic potential in Th2 and Th17-mediated autoimmune and allergic diseases Corvus confirms plans to initiate a Phase 2 clinical trial of CPI-818 in T cell lymphoma and a Phase 1 clinical trial in atopic dermatitis,…

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Biomea Fusion Presents at the 2022 ASH Annual Meeting Preclinical Data on BMF-500 Supporting its Potential as the Most Potent and Selective FLT3 Inhibitor to Date


BMF-500, an investigational third generation covalent FLT3 inhibitor, demonstrated preclinically: Biomea Fusion remains on track to file an IND for BMF-500 in the first half of 2023 Excerpt from the Press Release: REDWOOD CITY, Calif., Dec. 12, 2022 (GLOBE NEWSWIRE) — Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing…

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Neuvivo’s NP001 for Treatment of ALS Slows Disease Progression Through Regulation of Microbial Translocation


Paper Published in ‘Biomedicines’ Highlights MOA, Links Biomarker Changes to Positive Clinical Outcomes Excerpt from the Press Release: PALO ALTO Calif., Dec. 1, 2022 /PRNewswire/ — Neuvivo today announced the publication of a peer-reviewed paper titled: “Macrophage Targeted Sodium Chlorite (NP001) Slows Progression of ALS through Regulation of Microbial Translocation”. The goal of the biomarker-focused…

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