Category Archives: Topics

FENIX Analysis: Lilly Oral GLP-1RA Pivotal Program

Lilly initiated the first Ph3 trial in its QD oral GLP-1RA (orforglipron; LY3502970) T2DM pivotal program, called “ACHIEVE.” The ACHIEVE-4 trial is comparing orforglipron vs. insulin glargine in patients with T2DM and obesity or overweight at increased CV risk (view CT.gov record). Below, FENIX provides insights into the orforglipron development program, including thoughts on why Lilly will forego a post-marketing T2DM CVOT in favor of an obesity CVOT.

This content is for Read Less members only.

Already a member? Log in here

Abbott Recalls FreeStyle Readers

On April 4, 2023, FDA posted an announcement to its Medical Device Recalls page identifying Abbott’s recall on the FreeStyle Libre family of readers used with the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash CGMs for risk of extreme heat and fire as a Class I Recall (view FDA announcement). Below, FENIX provides brief insight into the impact of the recall.

This content is for Read Less members only.

Already a member? Log in here

Lannett Announces Positive Pivotal Bs-Glargine Results; Mark Cuban’s Pharmacy Offers Janssen’s Invokana; Diamyd Partners with JDRF for Ph3 Diamyd T1DM Development

Three cardiometabolic-related news items have been observed: Lannett announced topline results from its bs-glargine U100 pivotal study (view press release; view CT.gov record); Mark Cuban Cost Plus Drug Company (view website) announced it is now offering Janssen’s Invokana, Invokamet, and Invokamet XR (view tweet); and Diamyd Medical announced it entered into a four-year research and development collaboration with JDRF to support its ongoing Ph3 DIAGNODE-3 trial in T1DM (view press release). Below, FENIX provides highlights and insights into the respective news items including potential readthrough from recent insulin price reductions announced by Lilly, Novo, and Sanofi to Lannett’s bs-glargine.

This content is for Read Less members only.

Already a member? Log in here

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.

This content is for Read Less members only.

Already a member? Log in here

Wegovy and Entresto Receive Positive CHMP Opinions for Pediatric Indication Extensions

Two cardiometabolic-related news items have been observed: Novo’s Wegovy (semaglutide) received a positive CHMP opinion to extend the weight management indication to include treatment of adolescents aged 12-18 years (view March CHMP meeting highlights); and Novartis announced that CHMP has adopted a positive opinion recommending the approval of Entresto (sacubitril/valsartan) for the treatment of symptomatic HF with left ventricular systolic dysfunction in pediatric patients aged 1 to <18 years (view press release). Below, FENIX provides highlights and insights into the respective news items.

This content is for Read Less members only.

Already a member? Log in here

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.

This content is for Read Less members only.

Already a member? Log in here

FDA Releases Framework for Use of Digital Health Technology in Clinical Trials; New Ph2 Dapiglutide Obesity Trial

Two cardiometabolic-related news items have been observed: As part of FDA’s PDUFA VII commitments, the Agency published framework (view here) describing how it plans to address questions on the use of digital health technology (DHT) in clinical trials; and a Ph2 trial evaluating Zealand’s subcutaneous QW dapiglutide in obese participants with a BMI ≥ 30 kg/m² has been observed (DREAM; view CT.gov record). Below, FENIX provides highlights and insights into the respective news items.

This content is for Read Less members only.

Already a member? Log in here

Viking Announces Positive Ph1 GLP-1/GIP Dual Agonist Topline Results and Initiates Oral Formulation Development; Zealand Ph1a Amylin Analog Results; Biomea Ph2 Menin Inhibitor Results

Four cardiometabolic-related news items have been observed: Viking Therapeutics announced positive topline results from the Ph1 SAD/MAD clinical trial evaluating its novel QW subcutaneous GLP-1+GIP dual agonist (VK2735; view press release) and initiated a new Ph1 study for an oral formulation of VK2735 (view press release); Zealand Pharma announced positive results from a Ph1a study of ZP8396, an amylin analog, assessing safety and PK/PD effects in healthy lean and overweight people (view CT.gov record; press release); and Biomea Fusion announced positive topline results for the first two cohorts enrolled in the Ph2 portion of its ongoing Ph1/2 COVALENT-111 study (view CT.gov record) evaluating BMF-219, a covalent menin inhibitor (view press release). Below, FENIX provides highlights and insights into the respective news items.

This content is for Read Less members only.

Already a member? Log in here

Mounjaro Obesity Indication Filed in EU; March CHMP Agenda; Vertex Announces T1DM Licensing Agreement with CRISPR; Sanofi Helps Dario Secure Top-Ten PBM Contract

Three cardio-metabolic related news items have been observed: The CHMP agenda (view here) for this month’s meeting (March 27-30) has been released, which includes the new filing of the Mounjaro non-T2DM obesity indication; Vertex announced it has entered into a new non-exclusive licensing agreement with CRISPR Therapeutics for the use of CRISPR’s gene editing technology (view press release); and DarioHealth announced a new contract with an undisclosed top-ten PBM to provide Dario digital therapeutics beginning in Q2 2023 (view press release). Below, FENIX provides highlights and insights from the respective news items, including potential readthrough to the US Mounjaro obesity regulatory strategy.

This content is for Read Less members only.

Already a member? Log in here

Positive High-Dose Oral Semaglutide Topline Results

Novo Nordisk announced positive topline results from the PIONEER PLUS trial (view CT.gov record) evaluating high-dose oral semaglutide (25mg and 50mg). Interestingly, Novo stated it anticipates filing the 25mg and 50mg oral semaglutide doses for regulatory approval in the US and EU in 2023 although the “global roll-out of the 25mg and 50mg doses is contingent on portfolio prioritizations and manufacturing capacity.” Below, FENIX provides an overview of the high-dose Rybelsus data as well as insight into Novo’s decision for launching the additional doses.

This content is for Read Less members only.

Already a member? Log in here