Tag Archives: GSK

NeuroBo Submits NASH IND; New Akebia Vadadustat Data; Arrowhead Earns $30M Milestone Payment from GSK

Three cardiometabolic-related news items have been observed: NeuroBo Pharmaceuticals announced it has submitted an IND to FDA for a Ph2a trial of DA-1241, a novel G-protein-coupled receptor (GPR119) agonist in development for the treatment of NASH (view press release); Akebia Therapeutics announced positive topline results from the Ph3 FO2CUS trial (view CT.gov record) evaluating vadadustat in hemodialysis patients who were converted from Mircera to three times weekly oral vadadustat for the maintenance treatment of anemia due to CKD (view press release); and Arrowhead Pharmaceuticals announced that it earned a $30M milestone payment from GSK following the start of GSK’s Ph2b trial of GSK4532990 (formerly called ARO-HSD) in patients with NASH (view press release; previous FENIX insight). Below, FENIX provides highlights and insight from the respective news items.

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Akero to Initiate Ph3 NASH Program; Bigfoot Acquires Insulin Titration Algorithm; GSK Collaborates with PathAI in NASH

Three cardiometabolic-related news items have been observed: Akero Therapeutics announced it had a positive end-of-Ph2 meeting with FDA and disclosed details of the anticipated SYNCHRONY Ph3 efruxifermin (EFX) program for the treatment of NASH (view press release); Bigfoot Biomedical has acquired an insulin titration algorithm developed at McGill University (view press release); and PathAI announced it is partnering with GSK on the Ph2b HORIZON NASH trial (view CT.gov record; press release). Below, FENIX provides highlights and insights into the respective news items including thoughts on the competitive NASH therapies in development.

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JPM 2023 Day 2: LLY, ABT, PODD, SNY, AZN, MRK, and GSK; Sernova Advances T1DM Cell Pouch Technology; Pfizer Initiates New Ph1 Oral GLP-1RA Trial

On the second day of JPM 2023, FENIX has provided coverage of presentations by major CVRM companies including Lilly, Abbott, Insulet, AZ, and Merck. GSK and Sanofi also presented at JPM 2023, but neither had any meaningful discussion relating to their respective CVRM portfolios. Separately, two CVRM-related news items have been observed: Sernova announced it has made progress toward a first in-human study for its cell pouch system (view press release); and Pfizer initiated a new Ph1 trial (view CT.gov record) for one of its oral GLP-1RA assets (PF-07081532).

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Biocorp and Novo Sign New Connected Care Agreement; Daprodustat Adcom: 13-3 in Favor of Dapro in DD; 5-11 Against Dapro in NDD

Two cardiometabolic-related news items have been observed: Biocorp announced it signed a new agreement with Novo Nordisk reinforcing their partnership to develop the Mallya smart add-on device compatible with the Novo FlexTouch platform; and FDA hosted an adcom for GSK’s daprodustat where the panel voted 13-3 in favor of the dapro benefit/risk profile in the DD patient population and 5-11 against the benefit/risk profile in the NDD patient population. Below, FENIX provides highlights and insights for the respective new items.

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Medtronic Launches 770G Personalized Insights Program; GSK Initiates Ph2b NASH Trial; J&J Q3 ’22 Earnings Update

Three cardiometabolic-related news items have been observed: Medtronic announced the launch of a new personalized program, called My Insights, which is designed to support patients using the MiniMed 770G AID system (view website); a new GSK-sponsored Ph2b trial (HORIZON) has been observed evaluating GSK4532990 (HSD17B13 silencer) in adults with NASH (view CT.gov record); and J&J hosted their Q3 ‘22 earnings call (press release; slides). Below, FENIX provides highlights and insights for the respective new items.

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Daprodustat FDA Adcom Scheduled for October 26, 2022

FDA has requested an advisory committee on October 26, 2022, to discuss the use of GSK’s daprodustat for the treatment of anemia due to CKD in non-dialysis dependent (NDD) and dialysis-dependent (DD) adults (view FDA document here). Recall, in April 2022, FDA accepted the daprodustat NDA and set a PDUFA date for February 1, 2023, suggesting a standard review of 12 months total for an NME (previous FENIX insight). The NDA was based on positive results from five Ph3 studies in the ASCEND program which were reported in July 2021 (previous FENIX insight). Below, FENIX provides brief thoughts on the dapro adcom in the context of roxadustat and vadadustat.

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Daprodustat NDA Accepted by FDA; Sean Saint Looks to Do It Again; April 19-22 CHMP Agenda; J&J Q1 ’22 Earnings Update

Several cardiometabolic-related news items have recently been observed: GSK announced FDA accepted the daprodustat NDA for the treatment of patients with anemia due to CKD; Sean Saint has started a new company called Luna Diabetes (view website); the CHMP agenda for this month’s meeting (April 19-22) has been released; and J&J hosted their Q1’ 22 earnings call (press release; slides). Below, FENIX provides highlights and insights for the respective new items.

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GSK’s Daprodustat Ph3 Data Positive But Not Entirely Clean; BI/Lilly’s Jardiance Demonstrates Consistent Cardio-Renal Benefits in HF; Novo Announces Positive Ph3b STEP 5 Trial Results; CytoDyn Reports Positive Preliminary Data from Ph2 Leronlimab Trial; Roche and Sanofi Mallya Collaboration; Intuity Medical’s Automatic BGM Available in US; Zealand and DEKA Collaboration for Continuous Infusion Pump

A series of cardiometabolic-related news items have been observed from GSK, BI/Lilly, Novo Nordisk, CytoDyn, Roche, Intuity Medical, and Zealand. Below, FENIX provides highlights and insights for the respective news items.

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Metacrine Discontinues NASH Program; Ikenna Ogbaa Joins GSK to Lead Daprodustat Medical Team; Biocon CY Q3 ’21 (FY Q2 ’22) Earnings Update; Integrity Applications Hires New President and COO

A series of cardiometabolic-related news items have been observed: Metcarine announced it is discontinuing its NASH FXR development program following Ph2a interim results; Ikenna Ogbaa, MD joins GSK to lead daprodustat US medical affairs (view LinkedIn profile); Biocon hosted its Q3 ’21 (FY Q2 ’22) earnings call (press release); and Integrity Applications announced Dr. Paul V. Goode (view LinkedIn) will join the company as the new President and COO. Below, FENIX provides highlights and insights for the respective news items.

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