Adocia announces program to develop two basal insulin/GLP-1 agonist combinations using proprietary BioChaperone technology – September 9, 2016

Adocia announced plans on Wednesday to develop two new basal insulin/GLP-1 agonist combination products – BioChaperone Glargine Dulaglutide (insulin glargine/dulaglutide) and BioChaperone Glargine Liraglutide (insulin glargine/liraglutide) – using its proprietary BioChaperone technology. The technology stabilizes insulin glargine (Sanofi’s Lantus) to facilitate combination with other compounds, in this case Lilly’s Trulicity (dulaglutide) and Novo Nordisk’s Victoza (liraglutide). Adocia shared that it expects to initiate a clinical trial involving a lead candidate in 2017 and suggested that development for these combinations will proceed relatively quickly given the well-characterized clinical efficacy and safety profiles of the two drug components. We’re happy to see Adocia double-down on its commitment to the diabetes field and are excited to see the company tackle GLP-1 agonists.

At this point, Adocia plans to formulate both combinations as once-daily products. Both current late-stage basal insulin/GLP-1 agonist offerings from Novo Nordisk (IDegLira [insulin degludec/liraglutide], available in Europe as Xultophy and awaiting FDA decision) and Sanofi (iGlarLixi [insulin glargine/lixisenatide], awaiting FDA decision) are daily injections as well. The company has emphasized that it is working to deliver top products that have a potential price benefit over purely new molecules by employing existing approved products. Although no pricing has been formally disclosed at this stage, we appreciate Adocia stating so explicitly that access is a major goal.

Management also shared that Adocia does not plan to commercialize either candidate product on its own, suggesting a licensing agreement down the road. We imagine Lilly could potentially be interested in BioChaperone Glargine Dulaglutide, as it involves a combination of two products already in Lilly’s portfolio (Trulicity and biosimilar insulin glargine Basaglar). Lilly’s own basal insulin/GLP-1 agonist combination is still in the preclinical stages and involves a new once-weekly basal insulin that is likely a riskier proposition, so the combination of two well-established products may be attractive for the company. Furthermore, Lilly has a history of licensing Adocia’s BioChaperone products that are based on existing Lilly products: The two companies are partnered on BioChaperone Lispro, an ultra-fast-acting formulation of Lilly’s Humalog (insulin lispro). 

• Adocia will join Novo Nordisk, Sanofi, Lilly, PhaseBio, and AntriaBio in the competitive landscape for basal insulin/GLP-1 agonist products. Novo Nordisk’s Xultophy is already approved in Europe and is neck-and-neck with Sanofi’s iGlarLixi to be first-to-market in the US – FDA decisions for both are now expected by the end of 2016. During an R&D update meeting in May, Lilly management shared preclinical plans for a potential once-weekly formulation of basal insulin/Trulicity. PhaseBio is working on PEO139, a super-long-acting basal insulin that could be combined with GLP-1 agonist PB1023 for once-weekly dosing, while AntriaBio is developing AB301 as a once-weekly basal insulin/GLP-1 agonist formulation – both of these combinations are also preclinical. We expect once-weekly injections would provide a stronger clinical profile to compete with the established Xultophy and iGlarLixi once Adocia’s candidates reach the market in a few years, though Adocia expressed concerns over the dosing difficulty and safety of once-weekly insulins.
• We expect Adocia will benefit from lessons learned from the rather arduous regulatory process currently underway for iGlarLixi and IDegLira. The FDA has requested additional information from Sanofi on the pen delivery device for iGlarLixi, a major reason for the three-month extension for regulatory review. Notably, these concerns were voiced at the FDA Advisory Committee meeting for iGlarLixi, although these were overpowered by moving patient endorsements, in our view. Clearly, details of the delivery device for Adocia’s new basal insulin/GLP-1 agonist products will be important. Novo Nordisk’s press release explaining the three-month delay for IDegLira approval in the US only mentioned “a technicality” for which the company has a solution. We assume the regulatory delays for IDegLira and iGlarLixi are at least partly attributable to the novelty of the class and concept – these will be the first fixed-ratio injectable combinations of two different diabetes drug classes to reach the market. We expect that the development and submission process for Adocia’s combinations will benefit greatly from the prior experiences with IDegLira and iGlarLixi.
• The addition of the new BioChaperone programs to Adocia’s pipeline underscores the company’s commitment to diabetes. Management highlighted Adocia’s strategic decision to focus exclusively on diabetes during the company’s 2Q16 update. We’re certainly happy about what this could mean for diabetes therapies, especially with a BioChaperone glucagon project also in the works. Despite the high bar set for new diabetes drugs, we’re excited about the prospect of having multiple basal insulin/GLP-1 agonist agents available to patients, given their ability to substantially lower A1c without causing major aversive side-effects.
• This will be the first time BioChaperone is used with GLP-1 agonists. Other uses of Adocia’s proprietary technology include multiple insulin formulations and a soluble glucagon formulation.

-- by Payal Marathe, Helen Gao, and Kelly Close