Tag Archives: Novo Nordisk

New Oral Sema High-Dose and Flexible Administration Ph1 Trials from Novo

Two new Ph1 trials for Novo Nordisk’s oral semaglutide have been observed on CT.gov. The first Ph1 trial (NCT04524832) is evaluating high-dose oral semaglutide (25mg and 50mg), and the second study (NCT04513704) is comparing flexible administration schedules in terms of the required food restriction. Below, FENIX provides an overview of both trials as well as insight into why each of the trials clearly fit into Novo’s strategy for its GLP-1RA franchise.

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Novo Signs New CKD Development Deal with Evotec

Evotec and Novo Nordisk announced a new strategic collaboration focusing on the discovery and development of treatments targeting CKD. Recall, in August 2018, Novo and Evotec entered into an initial partnership targeting diabetes, obesity, NASH, and DKD (previous FENIX insight). Below, FENIX provides brief thoughts on the new collaboration in the context of Novo’s ziltivekimab acquisition, also for the treatment of CKD (previous FENIX insight).

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AZ to Withdraw Qtrilmet Marketing Authorization; CHMP Agenda August 17-20

The CHMP agenda for this month’s meeting (August 17-20) has been released, and it includes one notable item: Qtrilmet marketing authorization withdrawal. Of note, the August 2020 CHMP meeting agenda was just posted today despite the fact that the meeting started on August 17. Additionally, the August CHMP meeting does not include oral explanations, only written procedures. Below, FENIX provides diabetes-related highlights and insights from the August 2020 CHMP agenda.

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Novo Invests in Upgrading Kalundborg Manufacturing Facility

Novo Nordisk announced an investment of DKK 850M (~$135M USD) into expanding its production site in Kalundborg, Denmark. According to the press release, Novo manufactures half of the world’s insulin supply and carries out the assembly and packaging of diabetes and biopharm products at this site. This most recent investment brings Novo’s 2020 Kalundborg investments to nearly $318M USD. Below FENIX provides thoughts on the manufacturing investment in the context of the potential products it could support.

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Novo Q2 ’20 Roadshow; Provention Bio Q2 ’20 Earnings Update; Senseonics Eversense Covered by Highmark

Novo Nordisk hosted its post-Q2 ’20 earnings roadshow event (see previous FENIX insight on Q2 ’20 Novo earnings from August 6). Additionally, Provention Bio hosted its Q2 ’20 earnings call yesterday (press release), and Senseonics announced a positive coverage decision for its implantable CGM from Highmark. Below, FENIX provides highlights and insights from the respective news item and earnings calls.

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Novo Discontinues its Dual/Triple Agonists for Obesity; Novo Q2 ’20 Earnings Update

Novo Nordisk hosted its Q2 ’20 earnings call (press release; slides) and provided updates to its diabetes, obesity, and NASH clinical and commercial activities, but much of the discussion was focused on Novo’s obesity portfolio. Importantly, Novo disclosed it has discontinued the development of its dual and triple agonists for the treatment of obesity following positive results from the recent semaglutide and AM833 data disclosures (semaglutide Ph3 STEP, Ph2 AM833, and Ph1 sema+AM833). Additionally, FENIX includes context from Novo’s invite-only R&D event on June 19 (view slides here). Below, FENIX provides highlights and insights from the call, including why it makes sense Novo would use its PRV for semaglutide in obesity.

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Novo’s First Ph3 Icodec Trial (ONWARDS 1) Posted on CT.gov

A new CT.gov record has been observed for Novo Nordisk’s first Ph3 trial evaluating its QW insulin icodec insulin-naïve T2DM patients (ONWARDS 1). Novo appears to be branding the Ph3 program as “ONWARDS” in an effort to pay homage to the continued development story of insulin. In case you missed it, Lilly recently initiated two Ph2 trials for its QW insulin (LY3209590) in both T1DM and T2DM (previous FENIX insight). Below, FENIX provides an overview of the ONWARDS 1 trial as well as brief thoughts on Novo potentially providing additional clarity during its upcoming Q2 ’20 earnings call on August 6, 2020.

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New Lilly QW Insulin Ph2 Trials in T1DM and T2DM

Two new Ph2 trials have been observed on CT.gov evaluating Lilly’s QW basal insulin (LY3209590) in T1DM (view CT.gov record) and insulin-naïve T2DM patients (view CT.gov record). Below, FENIX provides trial details and thoughts on the new trials in the context of Novo Nordisk’s QW basal insulin (icodec), which recently had full Ph2 results presented at ADA 2020 (previous FENIX insight).

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Novo Reports Impressive AM833 Ph2 and AM833+sema Ph1 Topline Results

Novo Nordisk announced positive topline results for its Ph2 AM833 and Ph1 AM833+semaglutide trials, both for the treatment of obesity. Novo previously disclosed AM833 has been given the INN of “cagrilintide.” Recall, on June 12, 2020, Novo reported topline results from the final two trials in its Ph3 semaglutide obesity program (previous FENIX insight). Below, FENIX provides an overview of the topline data as well as brief thoughts on AM833 in the context of Novo’s injectable semaglutide Ph3 obesity program.

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Semaglutide Ph3 Obesity Positive Topline Results (STEP 1)

Novo Nordisk announced positive topline results from the Ph3a STEP 1 trial evaluating the safety and efficacy of QW sc semaglutide 2.4mg on body weight (press release). Recall, STEP 1 is the second of the STEP trials to read out following STEP 4 in May (previous FENIX insight). Below, FENIX provides an overview of the STEP 1 results and the consistency with STEP 4.

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