Category Archives: Topics

Lilly Partners with Nimbus Therapeutics for Metabolic Drug Discovery; Arecor Reports Positive Topline Results from Second Ph1 uRAI Trial

Two cardiometabolic-related news items have been observed: Nimbus Therapeutics announced a new partnership with Lilly to develop novel small molecule therapies; and Arecor announced positive topline results from its second Ph1 AT247 trial comparing its ultra-rapid-acting insulin (AT247) to Novolog and Fiasp in T1DM patients. Below, FENIX provides highlights and insights for the respective new items.

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Indigo Expands Multi-Metabolite Sensor Development; GlucoTrack to Develop CGM for T1DM; AZ Initiates New Dapa + Zibotentan Ph2 Trial; Sciwind Initiates Patient Dosing in Ph1 Oral GLP-1RA Trial; Ascensia Completes Initial European E3 CGM Launch; October CHMP Agenda

A series of cardiometabolic-related news items have been observed from Indigo, GlucoTrack, AstraZeneca, Sciwind, Ascensia, and EMA. Below, FENIX provides highlights and insights for the respective new items.

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Abbott Expands Libre 3 Distribution to Pharmacy; Second Ph3 Cagrisema Trial Posted on CT.gov; Galectin NASH Trial to Continue After Second DSMB Meeting

Three cardiometabolic-related news items have been observed: Abbott’s Freestyle Libre US patient website has been updated to announce the expansion of Libre 3 distribution into retail pharmacies; the second trial in Novo Nordisk’s cagrisema pivotal program (REDEFINE) has been observed (REDEFINE 1; view CT.gov record); and Galectin Therapeutics announced positive feedback from its second DSMB meeting for the Ph2b/3 NAVIGATE study (view CT.gov record) evaluating belapectin in patients with liver cirrhosis caused by NASH. Below, FENIX provides highlights and insights for the respective new items.

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Tirzepatide Receives Fast Track Designation in Obesity; Provention Bio and Sanofi Join Forces for Potential Teplizumab US Launch

Two cardiometabolic-related news items have been observed: Lilly announced FDA granted Fast Track designation for the investigation of tirzepatide in adults that are obese or overweight with weight-related comorbidities; and Provention Bio and Sanofi US announced a co-promotion agreement for the commercialization of teplizumab in the US. Below, FENIX provides highlights and insights for the respective new items.

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Dexcom Expands ex-US G7 Launch; Novo to Initiate OASIS 4 Ph3 Oral Sema Obesity Trial; Lilly to Initiate two Lp(a) Ph2 Trials; Better Therapeutic Publishes BT-001 Pivotal Trial Results in Diabetes Care

Four cardiometabolic-related news items have been observed: Dexcom announced the launch of Dexcom G7 CGM in the UK, Ireland, Germany, Austria, and Hong Kong and hosted an associated pre-recorded streaming event (view here); a Novo-sponsored Ph3 study (OASIS 4) evaluating QD 25mg oral semaglutide in overweight and obese participants has been observed (view CT.gov record); Lilly initiated two Ph2 studies evaluating QD oral LY3453329 (KRAKEN; view CT.gov record) and injectable LY3819469 (view CT.gov record) in adults with elevated Lp(a); and Better Therapeutics announced the publication of 90-day results from its pivotal trial for BT-001, in Diabetes Care. Below, FENIX provides highlights and insights for the respective new items.

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Novo’s QW Insulin Icodec Meets Primary Endpoint in ONWARDS 5

Novo Nordisk announced positive topline results from the final QW insulin icodec Ph3 trial (ONWARDS 5). Recall, ONWARDS 5 is differentiated from the other five trials in the ONWARDS program as it uses the DoseGuide app for titration. Below, FENIX provides thoughts on Novo’s Ph3 ONWARDS icodec program, the utility of the DoseGuide app during icodec commercialization, and the potential regulatory timeline.

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Novo Nordisk and Ventus Therapeutics Partner for NASH; Intercept’s OCA Misses Primary Endpoint in Ph3 REVERSE Trial; Beta Bionics Publishes Pivotal Trial Results in NEJM; Diamyd Completes Dosing Patients in DIAGNODE-B Booster Trial

Four cardiometabolic-related news items have been observed: Ventus Therapeutics announced it entered into an exclusive WW license agreement with Novo Nordisk to develop and commercialize its NLRP3 inhibitor portfolio in multiple TAs including NASH; Intercept announced the Ph3 REVERSE trial of obeticholic acid (OCA) in compensated cirrhosis due to NASH failed to meet its primary endpoint; Beta Bionics published results from its insulin-only bionic pancreas pivotal trial in the New England Journal of Medicine (view publication); and Diamyd announced it dosed the last patient with an additional booster of the Diamyd vaccine in its DIAGNODE-B trial (view CT.gov record). Below, FENIX provides highlights and insights for the respective new items.

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Dexcom Invests in Nutromics $14M Series B; Vertex and MaxCyte Partnership for CRISPR/Cas9-based Gene-editing Program

Two cardiometabolic-related news items have been observed: Nutromics announced it raised $14M in a Series B financing round for its wearable diagnostic platform led by Dexcom Ventures, VU Venture Partners, and Artesian Investments; and MaxCyte announced it signed a strategic platform license with Vertex Pharmaceuticals. Below, FENIX provides highlights and insights for the respective new items.

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Tirzepatide Approved in Japan; Nemaura and EVERSANA Partner for BEATdiabetes; SURMOUNT-MMO Trial Record Posted

Three cardiometabolic-related news items have been observed: Lilly announced tirzepatide is approved in Japan (press release); Nemaura announced a preliminary commercialization agreement with EVERSANA for BEATdiabetes (press release); and Lilly’s Ph3 tirzepatide obesity outcomes trial (SURMOUNT-MMO) has been posted on CT.gov (view CT.gov record). Below, FENIX provides highlights and insights from the respective news items.

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New ADA/EASD 2022 T2DM Guidelines; EASD 2022 Key Press Releases (Sept 23)

On the final day of EASD 2022, two key news items were observed: ADA/EASD presented the updated T2DM consensus guidelines (journal publication; download slides), placing obesity management as a key consideration; and Ionis announced AstraZeneca decided not to advance their PCSK9i (ION449; AZD8233) despite achieving positive Ph2b results (press release). Below FENIX provides insights and context from the respective announcements.

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