Triple FDCs tipped to shake up already lucrative SGLT-2s market

SGLT-2s represent the newest class of the oral anti-diabetic medications to significantly change the landscape of the type 2 diabetes (T2D) market. Within this class, competition is heating up and there are already three marketed drugs fighting for a slice of the lucrative diabetes space: AstraZeneca‘s Farxiga (dapagliflozin), Johnson & Johnson’s Invokana (canagliflozin), and Eli Lilly’s Jardiance (empagliflozin).

One of the pronounced recent trends in diabetes players’ strategies is towards creating fixed-dose combinations (FDCs) of SGLT-2s and other oral agents. The talks at the EASD meeting carried a hint that triple FDCs will soon be created. Such triple FDCs would represent a more convenient treatment as they would reduce “the pill burden” for T2D patients taking multiple medications, and thereby improve adherence to drug treatment.

At the EASD meeting, Eli Lilly and its partner, Boehringer Ingelheim (BI), reported that the FDC of an SGLT-2 inhibitor, Jardiance, and a dipeptidyl peptidase-4 (DPP-4) inhibitor, Tradjenta (linagliptin), as an add-on to metformin achieves better glucose lowering than Jardiance/metformin and Onglyza (saxagliptin)/metformin combinations alone in T2D patients with poor glycemic control. Almost twice as many patients using the triple therapy achieved the glycemic targets. The triple combinations were well tolerated, with a safety profile similar to monotherapy with these drugs.

Such results will encourage Eli Lilly/BI to create a single pill with all three drugs together, which could lead to the first triple FDC in the T2D market. AstraZeneca presented similar results with its SGLT-2 inhibitor, Farxiga, in combination with Onglyza as an add-on to metformin.

One possible barrier to the uptake of FDCs lies with their currently unclear position in the treatment paradigm recommended by the American Diabetes Association (ADA)/EASD guidelines. Nevertheless, the convenience and increased adherence to therapy will be a strong driver for the growth of the triple FDCs, and sooner or later, their place in the guidelines will be defined.

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Promising results announced for improved glycemic control

Some of the most exciting results in the glucagon-like peptide-1 receptor agonists (GLP-1 RA) space, albeit previously showcased during the ADA meeting in June, came from the biotech company, Intarcia, which again presented the interim Phase III data on its investigational GLP1 RA drug, ITCA 650 (continuous subcutaneous delivery of exenatide).

The FREEDOM-HBL (high baseline) trial showed that ITCA 650 has the potential to markedly improve glycemic control in patients with severe hyperglycemia and longstanding diabetes, and offers potential benefits over the existing T2D therapies. These benefits are reflected in sustained glycemic control, a favorable weight profile, and improved tolerability, and maybe, most importantly, an ensured adherence to therapy, as Intarcia’s proprietary technology platform involves a matchstick-size, miniature osmotic pump that is implanted subdermally to provide continuous and consistent drug therapy.

This formulation technology allows for once- or twice-yearly injection-free dosing. If this procedure is proven successful, and if Intarcia enters into licensing or collaboration agreements with more experienced and well-funded players in the diabetes market, ITCA 650 has the potential to dominate the entire GLP-1 RA segment.

More data from the FREEDOM Phase III program are eagerly awaited and should be announced at major medical meetings throughout the rest of 2014 and 2015.

New insulin formulations show massive potential for Type 1 Diabetes

One of the hottest topics at the EASD meeting, particularly with regard to type 1 diabetes (T1D) treatment, was with the new insulin formulations. These formulations ranged from insulin biosimilars and novel ultra-long-acting insulin analogs, to the most promising ultra-rapid formulations of the currently marketed rapid-acting insulin analogs.

The latter formulations show clear potential to radically change the insulin market over the next five years. A substantial and ongoing increase in insulin pump usage in recent years, as well as the rapid development of a closed-loop system (or “artificial pancreas,” where continuous glucose monitoring, a control algorithm, and an insulin pump device are combined), strengthen the need for insulins that are even faster-acting than the currently marketed rapid-acting insulin analogs.

This trend will significantly impact the whole insulin market, as only fast-acting insulin can be used with the pump therapy. Therefore, the usage of basal (long-acting) insulin analogs may decrease as rapid- and ultra-rapid-acting analogs slowly take over the T1D market.

Ultra-rapid formulations of rapid-acting analogs are currently in development by Novo Nordisk, Adocia, Biodel, and Halozyme. These formulations, in particular, may profit from the increase in pump therapy use, as they better match the physiological profile of prandial insulin. Ultra-rapid-acting formulations will also help with the development of artificial pancreas systems, as their fast reaction time could allow the pumps’ algorithms to dose insulin in real time.

Novo Nordisk’s FIAsp (NN-1218) is an ultra-rapid-acting formulation of NovoLog/NovoRapid (insulin aspart). At the EASD meeting, the company presented data from Phase I trials where FIAsp improved postprandial glycemia versus NovoLog in T1D patients. FIAsp will aim to continue NovoLog’s legacy and further protect NovoLog’s franchise from generic erosion to biosimilars after the patent for the drug expires throughout 2014 and 2015.

Of all the novel ultra-rapid insulin formulations presented at the EASD, Adocia’s BioChaperone insulin, lispro, is the furthest along in development. It is currently not clear whether this product is better than Novo Nordisk’s FIAsp, as there were no head-to-head studies. Adocia will have to either raise more capital or enter into licensing or collaboration agreements with more experienced and well-funded players in the insulin market, such as Novo Nordisk, Eli Lilly, or Sanofi, in order to successfully develop and market its product in the world’s major markets.

One of the take-home messages of the EASD conference for T1D patients was that the ultra-rapid-acting insulin formulations certainly represent the future for the treatment of these patients, as the artificial pancreas will likely become a reality over the next several years. The main message for T2D patients was that triple combo pills are on the way, as well as the once- or twice-yearly injection-free dosing of GLP-1RAs, which will greatly reduce the therapy burden for these patients.