Phases of clinical research

BenevolentAI Announces Positive Topline Safety and Pharmacokinetic Data from the Phase Ia Clinical Study of BEN-8744 in Healthy Volunteers

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Monday, March 25, 2024
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BenevolentAI (“BenevolentAI” or the “Company”) (Euronext Amsterdam: BAI), a leader in applying advanced AI to accelerate biopharma drug discovery, today announces positive safety data from its Phase Ia, first-in-human, clinical study of BEN-8744 in healthy volunteers.

Key Points: 
  • BenevolentAI (“BenevolentAI” or the “Company”) (Euronext Amsterdam: BAI), a leader in applying advanced AI to accelerate biopharma drug discovery, today announces positive safety data from its Phase Ia, first-in-human, clinical study of BEN-8744 in healthy volunteers.
  • As a result, BenevolentAI’s scientists designed BEN-8744 to be not only a potent PDE10 inhibitor, but also a peripherally-restricted molecule, i.e.
  • The Phase Ia study results support this profile, showing no evidence of CNS-associated adverse events at any dose level.
  • It is anticipated that the full results from this study will be presented in a peer-reviewed forum at a later date.

HUTCHMED Reports 2023 Full Year Results and Provides Business Updates

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Wednesday, February 28, 2024
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HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Feb. 28, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”, the “Company” or “we”) (Nasdaq/AIM:​HCM; HKEX:​13), the innovative, commercial-stage biopharmaceutical company, today reports its financial results for the year ended December 31, 2023 and provides updates on key clinical and commercial developments. HUTCHMED to host results call and webcasts today at 7:30 a.m. EST / 12:30 p.m. GMT / 8:30 p.m. HKT in English, and at 8:30 a.m. HKT in Chinese (Putonghua) on Thursday, February 29, 2024.

Key Points: 
  • HUTCHMED is committed to progressively embedding sustainability into all aspects of our operations and creating long-term value for our stakeholders.
  • The 2023 Sustainability Report will be published alongside our 2023 Annual Report in April 2024 and will include further information on HUTCHMED sustainability initiatives and their performance.
  • Net Income attributable to HUTCHMED for 2023 was $100.8 million compared to Net Loss attributable to HUTCHMED of $360.8 million in 2022.
  • The net income attributable to HUTCHMED in 2023 was $0.12 per ordinary share / $0.59 per ADS49, compared to net loss attributable to HUTCHMED of $0.43 per ordinary share / $2.13 per ADS in 2022.

NodThera Publishes Preclinical Data Demonstrating Reversal of Obesity and Inflammation with Clinical-stage Brain-penetrant NLRP3 Inflammasome Inhibitors

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Monday, February 19, 2024
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The data are published in the Journal of Pharmacology and Experimental Therapeutics in a paper titled ‘Reversal of high fat diet-induced obesity, systemic inflammation and astrogliosis by the NLRP3 inflammasome inhibitors NT-0249 and NT-0796’1.

Key Points: 
  • The data are published in the Journal of Pharmacology and Experimental Therapeutics in a paper titled ‘Reversal of high fat diet-induced obesity, systemic inflammation and astrogliosis by the NLRP3 inflammasome inhibitors NT-0249 and NT-0796’1.
  • The NLRP3 inflammasome is a highly validated anti-inflammatory drug target, and these findings demonstrate that NLRP3 plays a key role in controlling obesity and obesity-associated inflammation through the modulation of hypothalamic gliosis.
  • Both NT-0796 and NT-0249, two structurally distinct NLRP3 inhibitors in clinical development by NodThera, have generated a wealth of preclinical and clinical data demonstrating brain-penetration and broad anti-inflammatory effects, with NT-0796 being the first NLRP3 inhibitor to show reduced neuroinflammation in the clinic.
  • Our ongoing Phase IIa study in obese individuals at cardiovascular risk will further validate these pre-clinical findings.”
    Reversal of High Fat Diet-Induced Obesity, Systemic Inflammation, and Astrogliosis by the NLRP3 Inflammasome Inhibitors NT-0249 and NT-0796.

Ryvu Announces Dosing of the First Patient in the RIVER-52 Phase II Study of RVU120 as a Monotherapy for the Treatment of Patients with Relapsed/Refractory AML and HR-MDS

Retrieved on: 
Wednesday, February 14, 2024
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Ultimately, the study will expand to other EU and non-EU countries, covering up to 80 clinical sites globally.

Key Points: 
  • Ultimately, the study will expand to other EU and non-EU countries, covering up to 80 clinical sites globally.
  • RIVER-52 is a multicenter, open-label clinical trial designed to evaluate RVU120 in adult patients with r/r AML and HR-MDS, without alternative therapies.
  • RIVER-52 represents the second of the four planned RVU120 Phase II clinical studies scheduled for launch in H1 2024.
  • In addition to RIVER-52, Ryvu has already started patient treatment in the RIVER-81 study (evaluating RVU120 in combination with venetoclax for treating r/r AML patients).

Appendix 4C Quarterly Activity Report for Quarter Ended December 31, 2023

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Wednesday, January 31, 2024
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NEW YORK, Jan. 30, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an activity report for the second quarter ended December 31, 2023.

Key Points: 
  • NEW YORK, Jan. 30, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an activity report for the second quarter ended December 31, 2023.
  • Mesoblast will provide the Phase 3 trial protocol to FDA ahead of the upcoming meeting this quarter.
  • Mesoblast will meet with FDA this quarter to address potential pathways to approval for REVASCOR under our Regenerative Medicine Advanced Therapies (RMAT) designation.
  • Revenue from royalties on sales of TEMCELL® HS Inj.5 sold in Japan by our licensee for the quarter were US$1.5 million.

MetrioPharm Publishes First Trial Data Showing Effects of Host-Directed Therapy in COVID-19

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Wednesday, January 31, 2024
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A total of 131 COVID-19 patients were treated with Standard of Care (SoC) plus MetrioPharm’s lead compound MP1032 or with placebo.

Key Points: 
  • A total of 131 COVID-19 patients were treated with Standard of Care (SoC) plus MetrioPharm’s lead compound MP1032 or with placebo.
  • Patients treated with MP1032 (n=86) exhibited a lower mortality compared to those receiving placebo + SoC (n=45).
  • Moreover, the efficacy of MP1032 was enhanced when used in combination with anti-viral agents, including, but not limited to, remdesivir.
  • These protocols had been defined with much larger studies in mind,” said MetrioPharm CSO and co-founder Dr. Wolfgang Brysch.

Ryvu Announces Dosing of the First Patient in the RIVER-81 Phase II Study of RVU120 in Combination with Venetoclax for the Treatment of Patients with Relapsed/Refractory AML

Retrieved on: 
Wednesday, January 31, 2024
Pharmacokinetics, Venetoclax, Ruxolitinib, MF, Ethics, Phases of clinical research, Clinical trial, Syndrome, Patient, Safety, ABM, AML, Therapy, Phase, Committee, Optimism, PD, Pharmaceutical industry

The primary goal of the RIVER-81 study will be to evaluate safety and efficacy of RVU120 in combination with venetoclax in r/r AML patients who have failed prior venetoclax treatment.

Key Points: 
  • The primary goal of the RIVER-81 study will be to evaluate safety and efficacy of RVU120 in combination with venetoclax in r/r AML patients who have failed prior venetoclax treatment.
  • The study is part of the RVU120 Development Plan presented in October 2023 and aligns with the company's cash runway to Q1 2026.
  • In H1 2024, Ryvu plans to launch four Phase II RVU120 clinical studies and enroll over 100 patients across the studies by the end of the year.
  • Following RIVER-81, Ryvu intends to initiate the RIVER-52 study (evaluating RVU120 as a monotherapy in patients with genetically defined subtypes of AML and in patients with HR-MDS).

AskBio Phase Ib trial of AB-1005 gene therapy in patients with Parkinson’s disease meets primary endpoint

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Thursday, January 4, 2024
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18-month assessment of all patients demonstrated feasibility of administration of AB-1005 to the putamen via one-time bilateral convection-enhanced delivery.

Key Points: 
  • 18-month assessment of all patients demonstrated feasibility of administration of AB-1005 to the putamen via one-time bilateral convection-enhanced delivery.
  • AskBio plans to present 18-month study data, including secondary endpoints, at a scientific meeting in Q2 of 2024.
  • Planning is underway for a Phase II trial to be initiated in the first half of 2024.
  • Planning is underway for a Phase II trial that is expected to begin screening patients in the first half of 2024.

Ryvu Therapeutics Reports Third Quarter 2023 Financial Results and Provides Corporate Update

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Wednesday, November 29, 2023
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Ryvu’s PRMT5 program and synthetic lethality platform were highlighted with preclinical data recently presented at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics.

Key Points: 
  • Ryvu’s PRMT5 program and synthetic lethality platform were highlighted with preclinical data recently presented at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics.
  • KRAKOW, Poland, Nov. 29, 2023 (GLOBE NEWSWIRE) -- Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, today reported financial results for the third quarter of 2023 and provided a corporate update.
  • “The third quarter and the last months of 2023 proved to be an exceptionally productive period for our company,” said Pawel Przewięźlikowski, CEO of Ryvu Therapeutics.
  • Cash Position – On November 24, 2023, Ryvu Therapeutics held $64.5M in cash, cash equivalents, and bonds, compared to $23.2M at the end of 2022.

New Data for Genentech’s Columvi and Lunsumio Presented at ASH 2023 Support Continued Benefit for People With Lymphoma

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Monday, December 11, 2023
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Additionally, new early-phase data of novel Columvi or Lunsumio combination regimens support ongoing investigation in Phase III studies in earlier lines of diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL).

Key Points: 
  • Additionally, new early-phase data of novel Columvi or Lunsumio combination regimens support ongoing investigation in Phase III studies in earlier lines of diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL).
  • After a median follow-up of 32 months, 55% of patients with a complete response (CR) were in remission at 24 months.
  • Data showed that 83.3% of patients achieved a complete metabolic response (95% CI: 62.6-95.3), and responses were ongoing at data cut-off.
  • The data support further investigation of this SC formulation of Lunsumio and highlight its potential as a tailored monotherapy or combination outpatient therapy for FL, including in community practices.