Company (location)

Product

Description

Indication

Status

Date


Amarin Corp. plc (Dublin)

EPA Vascepa

Icosapent ethyl

High triglycerides and diabetes mellitus type 2

Data from a post-hoc analysis of the ANCHOR study showed that, compared to placebo, Vascepa reduced triglyceride levels and several other potentially atherogenic lipid parameters and inflammatory markers, as well as significantly increasing blood EPA levels

6/13/17

Astrazeneca plc (London)

Farxiga

Dapagliflozin

Type 2 diabetes

Pooled phase IIb/III data showed no new safety signals, and the incidence of adverse events was generally similar to that in the control groups; there was no imbalance in lower-limb amputations, with eight (0.1%) patients and seven (0.2%) patients identified in the dapagliflozin and control groups, respectively; data from the real-world study showed a significant reduction in the rates of hospitalization for kidney disease by 62% (p<0.001), hospitalization for heart failure (HF) by 37% (p<0.001) and death from any cause by 27% (p=0.003) for patients using dapagliflozin vs. DPP-4 inhibitors; a three-country analysis of nearly 100,000 patients showed a significant reduction in rates of CV death by 47% (p<0.001) and hospitalization for HF by 30% (p<0.001), for patients new to SGLT-2 inhibitors vs. other type 2 diabetes medicines

6/13/17

Eiger Biopharma-ceuticals Inc. (Palo Alto, Calif.)

Exendin 9-39

GLP-1 antagonist that blocks GLP-1 from binding to the GLP-1 receptor

Post-bariatric hypoglycemia treatment

Patients provided with the liquid formulation during the phase II multiple-ascending dose study demonstrated improved post-meal metabolic and clinical parameters with comparable or greater activity vs. the lyophilized formulation; the liquid formulation also produced a pharmacokinetic profile which may confer a longer duration of action vs. the lyophilized formulation; both formulations were well-tolerated with no related adverse events

6/13/17

Flexion Therapeutics Inc. (Burlington, Mass.)

Zilretta

FX-006; intra-articular, extended-release treatment

Pain related to osteoarthritis of the knee in type 2 diabetes patients

Added detail to top-line results of a phase II study showing patients taking Zilretta led to a significantly lower change in average blood glucose (BG) concentration (14.7 mg/dL) than taking immediate release triamcinolone acetonide in crystalline suspension, or TAcs (33.9 mg/dL); mean average BG levels increased significantly from the pre-treatment baseline period to the post-treatment period in patients receiving TAcs, but did not change significantly in patients receiving Zilretta; incidences of adverse events in the study were low and similar between the Zilretta and TAcs treatment arms

6/13/17

Intercept Pharmaceuticals Inc. (New York)

OCA

Obeticholic acid

Nonalcoholic steatohepatitis and type 2 diabetes

In a retrospective analysis of patients in the phase II FLINT trial, both groups had high rates of advanced fibrosis; among those participants in the trial with both conditions at baseline, a greater percentage of obeticholic acid (OCA)-treated patients also achieved the primary endpoint of the trial: a two-point or greater improvement in their non-alcoholic fatty liver disease activity score without worsening of fibrosis, at week 72 as compared to placebo (57% vs. 21%, p<0.01)

6/13/17

Lexicon Pharmaceuticals Inc. (The Woodlands, Texas)

Sotagliflozin

Dual inhibitor of sodium-glucose co-transporter types 1 and 2

Type 1 diabetes

24-week data from two pivotal studies demonstrated that 200-mg and 400-mg doses, on top of optimized insulin, significantly reduced A1C compared to placebo (p<0.001 in both studies), and it was generally well tolerated; in both studies, there was a low rate of severe hypoglycemia and a low diabetic ketoacidosis rate (0.4% to 3.1% over 24 weeks) that was higher for patients on insulin pump vs. multiple dose injections

6/13/17

Merck & Co. Inc. (Kenilworth, N.J.) and Pfizer Inc. (New York)

Ertugliflozin

Oral sodium-glucose co-transporter type 2 inhibitor

To help improve glycemic control in adults with type 2 diabetes

Two phase III studies met their primary endpoints; both doses of ertugliflozin tested (5 mg and 15 mg daily) achieved statistically significant reductions in A1C when added to metformin or in initial co-administration with Januvia (sitagliptin); both studies found a higher incidence of genital mycotic infections in patients taking ertugliflozin

6/13/17

Mylan N.V. (Hertfordshire, U.K.) and Biocon Ltd. (Bengaluru, India)

MYL-1501D

Insulin glargine

Type 1 and type 2 diabetes

New data from the insulin glargine clinical program confirmed the efficacy, safety and immunogenicity of MYL-1501D in comparison to Lantus

6/13/17

Novelion Therapeutics Inc. (Vancouver, British Columbia)

Myalept

Metreleptin

Generalized lipodystrophy and diabetes

A post-hoc analysis of an open-label study found that treatment with Myalept allowed one-third of patients to stop treatment with all anti-diabetic medications, including insulin, for one year or more

6/13/17

Novo Nordisk A/S (Bagsværd, Denmark)

Tresiba

Insulin degludec injection

Type 1 diabetes and type 2 diabetes

Patients in the EU-Treat (European Tresiba Audit) experienced a significant reduction in HbA1c (-0.2% for type 1 diabetes and -0.5% for type 2 diabetes) six months after switching to Tresiba from another basal insulin; rates of overall hypoglycemia were also significantly lower at six months after switching to Tresiba; in people with type 1 diabetes, the rate of severe hypoglycemia was reduced by 85% and by 92% in people with type 2 diabetes

6/13/17

Novo Nordisk A/S (Bagsværd, Denmark)

Xultophy 100/3.6

Insulin degludec and liraglutide injection 100 units/mL and 3.6 mg/mL

Type 2 diabetes

New results from the phase IIIb DUAL VII trial showed patients treated with Xultophy 100/3.6 vs. basal-bolus therapy also reached similar glycemic targets (66% vs. 67% for A1C <7%; 49.6% vs 44.6% for A1C ≤6.5%, respectively), demonstrated an 89% reduction in severe or blood glucose confirmed symptomatic hypoglycemic events, experienced a weight reduction of 0.93 kg (2.06 lb) compared with a weight gain of 2.64 kg (5.81 lb) for people treated with the basal-bolus regimen, and achieved glycemic control with no hypoglycemic episodes and no weight gain in the last 12 weeks

6/13/17

Prometic Life Sciences Inc. (Laval, Quebec)

PBI-4050

Oral anti-fibrosis treatment

Metabolic syndrome and type 2 diabetes

Results from a phase II clinical trial showed that, after 12 weeks of treatment with PBI-4050, a statistically significant reduction of microparticles shedding from the kidney in the patients' urine was observed

6/13/17

Remd Biotherapeutics Inc. (Camarillo, Calif.) and subsidiary Cosci-Remd Biotherapeutics

REMD-477

Fully human antibody that specifically binds to the glucagon receptor and blocks the action of glucagon

Type 1 diabetes

Phase I data showed that a single dose substantially reduced daily insulin requirements and glucose levels without increasing hypoglycemia in patients; results demonstrated that a single dose of REMD-477 decreased daily insulin use by up to 26% (12 units) during the in-patient period compared to placebo

6/14/17

Sanofi SA (Paris)

Toujeo

Insulin glargine injection

Type 2 diabetes

New evidence from a real-world observational study showed patients switching to Toujeo were 57% less likely to experience hypoglycemia at six-month follow-up than those who switched to another basal insulin, with similar glycemic control

6/13/17

Sanofi SA (Paris)

Soliqua 100/33

Insulin glargine and lixisenatide injection 100 units/mL and 33 mcg/mL

Type 2 diabetes

Announced it lowered mean blood sugar levels (HbA1c) by between 1.09% and 2.41% after 30 weeks in adults previously treated with between 15 and 40 units of basal insulin daily

6/13/17

Sanofi SA (Paris) and Regeneron Pharmaceuticals Inc. (Tarrytown, N.Y.)

Praluent

Alirocumab; PCSK9 inhibitor

Hypoglycemia in patients with type 1 and 2 diabetes

In type 2 diabetes patients, Praluent lowered LDL by 49% compared to the placebo after 24 weeks of treatment with 80% of patients taking Praluent reaching the recommended target LDL levels on the lower dose of 75 mg; in the ODYSSEY DM-Dyslipidemia trial, after 24 weeks of treatment, Praluent reduced non-HDL by 32.5% compared to standard of care used as the control

6/13/17

Vtv Therapeutics Inc. (High Point, N.C.)

TTP273

Small-molecule GLP-1 receptor (GLP-1R) agonist

Type 2 diabetes

Results from a phase II clinical study showed that lower doses of TTP273 may show more pronounced effects for key efficacy endpoints, including a reduction in HbA1c, weight and fasting plasma glucose; the characteristics of TTP273 provide a potential scientific rationale supporting the concept that for TTP273, less may be more

6/13/17

Zafgen Inc. (Boston)

ZGN-1061

Insulin glargine 300 units/mL; fumagillin-class, injectable small-molecule second-generation MetAP2 inhibitor

Type 2 diabetes and obesity

New data show that ZGN-1061 treatment causes improvements across multiple metabolic measures consistent with MetAP2 inhibition, demonstrates rapid drug absorption and clearance, and has a favorable safety profile with no evidence of prothrombotic effects; in a phase I trial, patients treated with ZGN-1061 for four weeks lost weight relative to placebo-treated patients (-4.6 lbs, -2.2 lbs, and -3.8 lbs for 0.2 mg, 0.6 mg, and 1.8 mg, respectively vs. -0.51 lbs for placebo) and the trial demonstrated trends for reductions in LDL-cholesterol, and high-sensitivity C-reactive protein

6/13/17

Zealand Pharma A/S (Copenhagen)

Dasiglucagon

Glucagon analogue

Insulin-induced hypoglycemia in patients with type 1 diabetes

Phase II data indicated that dasiglucagon rapidly increased plasma glucose (PG) levels after insulin-induced hypoglycemia, with dasiglucagon concentrations shown to increase rapidly and in a dose-dependent manner; the increase in PG was longer lasting and more pronounced with dasiglucagon than the approved rescue therapy, Glucagen, presenting a favorable efficacy profile; two hypoglycemia events occurred within six hours of dosing with dasiglucagon, compared to nine events with Glucagen

6/13/17


Notes

The date indicated refers to the BioWorld issue in which the news item can be found.

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