Clinical Catch-up for June 10-14

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Last week there were quite a few clinical trials whose data were presented. Many were at the American Diabetes Association (ADA) 79th Scientific Sessions, while others were presented at separate meetings or independently. Here’s a look.

Sanofi presented data from its Phase III LixiLan-G trial at the ADA meeting. The trial compared Sanofi’s Soliqua/Suliqua compared to other GLP-1 receptor agonists (GLP-1 RA), with Soliqua showing superior decrease of average blood sugar level (HbA1c) after 26 weeks.

The LixiLan-G trial looked at 514 adults with type 2 diabetes whose disease wasn’t well controlled by receiving GLP-1 receptor agonists. There was a broad range of available GLP-1 RAs, including either once-daily liraglutide (Novo Nordisk’s Victoza), twice-daily exenatide (Bydureon or Byetta), or once-weekly extenatide extended release, GlaxoSmithKline’s Tanzeum (albiglutide) or Eli Lilly’s Trulicity (dulaglutide), and metformin with or without pioglitazone, with or without a sodium-glucose transport protein 2 inhibitor (SGLT2i). Which primarily means Soliqua/Suliqua was compared to standard treatments for type 2 diabetes in patients who weren’t controlling their disease well.

After 26 weeks, patients who switched to Soliqua had a 0.6% better reduction in HbA1c compared to continuing treatment with GLP-1 RA. In particular, more patients on Soliqua hit HbA1c below the 7% target that the ADA recommends compared to those receiving other GLP-1 RA.

Eli Lilly and Company presented results from its REWIND clinical trial at the ADA meeting. It also simultaneously published the results in The Lancet.

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REWIND showed that patients on Trulicity (dulaglutide) had a 12% reduction in major cardiovascular events (MACE) compared to patients receiving placebo. The study assessed the effectiveness of Trulicity 1.5 mg, a weekly GLP-1 receptor agonist, compared to patients receiving placebo in adults with type 2 diabetes.

Provention Bio also presented data at the ADA meeting on its “At-Risk” Study. The study enrolled 76 people ages 7 to 49 who were “At-Risk” because of two or more type 1 diabetes (T1D) autoantibodies and abnormal glucose metabolism. In the group, 72% were under the age of 19. They received either PRV-031 (teplizumab) or placebo. The study showed that a single 14-day course of PRV-031 significantly delayed onset and diagnosis of clinical type 1 diabetes. The delay was a median of 2 years. The median time of clinical diagnosis of T1D for the placebo group was slightly over 24 months, while those receiving PRV-031 was just over 48 months. PRV-031 is an anti-CD3 monoclonal antibody.

Eisai announced detailed analysis from its Phase III program for lemborexant for insomnia, a sleep-wake disorder, and irregular sleep-wake rhythm disorder (ISWRD). “The Phase III pooled analyses provide new insights into lemborexant’s impact on insomnia severity and several other important sleep measures, including sleep onset, sleep maintenance, and next-day functioning,” stated Russell Rosenberg, a principal investigator in the trials and former Chairman of the Board of the National Sleep Foundation.” The FDA is reviewing the NDA for the drug for insomnia and has a target action date of December 27, 2019.

Novartis released new data from its FUTURE 5 clinical trial of Cosentyx (secukinumab) in psoriatic arthritis (PsA). Patients receiving Cosentyx showed no radiographic progression in almost 90% of PsA patients over 2 years. Of the patients receiving the drug at 150 mg, 66.3% had rapid and significant improvements in symptoms of the disease with axial manifestations at week 12. The trial looked at the effect of Cosentyx on symptoms of PsA, as well as inhibition of radiographic progression of the disease.

Genentech announced positive topline results from its Phase III PEMPHIX trial evaluating Rituxan (rituximab) compared to the immunosuppressant drug mycophenolate mofetil (MMF) in patients with pemphigus vulgaris (PV). PV is a rare autoimmune disease that causes blistering on the skin and mucous membranes.

“The PEMPHIX study provides additional clinical evidence for the use of Rituxan for the treatment of pemphigus vulgaris,” stated Sandra Horning, chief medical officer and head of Global Product Development for Genentech. “These data also demonstrated that Rituxan may provide complete remission rates and successful tapering of corticosteroid therapy that is superior to MMF in adults with pemphigus vulgaris.”

Savara’s Mogradex failed to hit its primary endpoints in a Phase III IMPALA study in late-stage autoimmune alveolar pulmonary proteinosis (aPAP). The primary endpoint was improved lung function. Malgradex is an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF). The disease is caused by a build-up of proteins and other substances in the alveoli of the lungs. Despite not meeting the primary endpoint, the company notes that many of the secondary endpoints may give them a way to continue forward with the drug, including an average improvement of 12.3 points in a quality of life measure.

bluebird bio released updated results from three of its clinical trials of its LentiGlobin gene therapy for transfusion-dependent Beta-thalassemia (TDT) at the 24th European Hematology Association (EHA) Congress being held in Amsterdam, the Netherlands.

In the Northstar trial, eight of 10 patients receiving treatment achieved transfusion independence (TI) for at least 12 months and are enrolled in a long-term follow-up trial. In Northstar-2, 20 patients were treated. Four of five who could be treated achieved TI and have a median duration of 13.6 months at the time of data cut-off. In Northstar-3, 11 patients were treated. One patient who was evaluable achieved TI and held it at 16 months. Five patients had stopped transfusions for at least three months.

Eli Lilly and Company announced positive findings from its Phase IIIb/IV SPIRIT-Head-to-Head (H2H) clinical trial comparing its Taltz (ixekizumab) to AbbVie’s Humira (adalimumab) in active psoriatic arthritis (PsA) at the European Congress of Rheumatology (EULAR) being held in Madrid, Spain.

The primary endpoint of the study was to show that Taltz was superior to Humira in treating PsA, which it did.

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Global Blood Therapeutics (GBT), based in Amsterdam, The Netherlands, reported new data from its Phase III HOPE trial of voxelotor in sickle cell disease (SCD). The drug met the primary endpoint, improvement in hemoglobin greater than 1 g/dL at 24 weeks, in 274 patients ages 12 and older with the disease. The HOPE trial involved 274 patients with SCD from 60 institutions across 12 countries.

The Janssen Pharmaceutical of Johnson & Johnson announced top-line data from the Phase III DISCOVER 1 and 2 trials. These compared guselkumab to placebo in adults with active moderate to severe psoriatic arthritis (PsA). Both trials met their primary endpoints, American College of Rheumatology 20% improvement (ACR20). The company plans to use the data from the two trials and submit to the FDA and EMA later this year.

Hutchison China MediTech (Chi-Med) announced an independent analysis of interim data from its Phase III trial of surufatinib in patients with low- or intermediate-grade advanced extra-pancreatic neuroendocrine tumors. The independent Data Monitoring Committee indicated the trial had already met the predefined primary endpoint of progression-free survival (PFS) and recommended the trial be stopped. The company will now plan a pre-New Drug Application meeting with the China National Medical Products Administration (NMPA) to discuss the planned NDA.


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