The CT.gov record for Novo’s Ph1 stable glucagon analog study (NN9030) has been updated, and the trial is now listed as “Suspended (Evaluation of data).” Below, FENIX provides potential scenarios for the recruitment suspension.
Voluntis and Monarch Medical Technologies have announced a strategic collaborationto integrate Voluntis’s personal T2DM diabetes platform (Insulia) with Monarch’s in-patient insulin titration tools (EndoTool IV and EndoTool SubQ). Below, FENIX provides insight into the collaboration including perspective on competition to Glytec who provides a similar product.
Novo Nordisk has announced topline results from the Ph3 PIONEER 4 (vs. 1.8mg Victoza) and PIONEER 7 (3, 7, and 14 mg oral sema dose escalation vs. Januvia) studies. Both trials met their primary outcomes (non-inferiority to Victoza and superiority to Januvia), and oral semaglutide also demonstrated statistically significant A1C and weight reduction vs. Victoza. Additionally, FENIX provides insight into a potential relationship between PIONEER 7 dose escalation and discontinuation rates observed in the reported PIONEER studies.
Novo Nordisk has announced a partnership with Kallyope for the discovery of peptides to treat diabetes and obesity. Below, FENIX provides thoughts on the Novo/Kallyope collaboration and apparent change in R&D strategy.
The DreaMed FDA approval for its Advisor Pro algorithm now empowers Glooko to compete with Medtronic’s CareLink across the patient and provider customer segments. Below, FENIX provides insight into Glooko’s enhanced position to compete with Medtronic’s CareLink in diabetes decision support services.
Medtronic announced it has expanded its partnership with Nutrino to integrate an updated FoodPrint App with the iPro2 professional CGM. Below, FENIX provides insight into the potential impact of the new feature and future application.
The FIGS-2 trial for GlySens’s implantable CGM, Eclipse, has completed according toCT.gov- two and a half years after the originally scheduled completion date of December 2015. The primary endpoint of the 20-subject study was adverse events. FENIX has conducted a headwinds/tailwinds analysis of the Eclipse system in the context of the larger CGM market.
A Montreal-based research group presented data at ADA on a dual-hormone artificial pancreas using both insulin and pramlintide. The study, presumed to be the clinical trial MAP-1, showed significantly improved glucose levels compared to an insulin-only artificial pancreas. Below, FENIX has provided context and insight regarding this study and its potential implications to the AP development space.
A CT.gov record for a study evaluating Novo’s Fiasp (faster-acting insulin aspart) in a Medtronic 670G pump has been observed. This Ph4 study is sponsored by Bruce Buckingham’s lab at Stanford, and Medtronic is listed as a collaborator (Novo is not believed to be part of the study). Recall, the Fiasp label does not include designation for use in insulin pumps. Below, FENIX provides insight into the use of ultra-rapid-acting insulin in pumps as well as why a future commercial partnership between Novo and Medtronic could make sense.
J&J announced it has accepted a final offer from Platinum Equity for the acquisition of the LifeScan BGM business. Recall, the offer was made in March 2018, and according to the press release, the transaction is anticipated to close by YE ’18.