Adocia Announces Expanded BioChaperone Product Portfolio Beyond Diabetes

Adocia today announced an update of its corporate strategy.

- Following its successful application to diabetes treatments, BioChaperone® technology will now be deployed in a selected range of injectable therapeutics across numerous therapeutic areas

- Initial programs added to the portfolio include a ready-to-inject version of teduglutide for the treatment of short bowel syndrome and a fixed dose combination of glucagon and exenatide for the treatment of obesity

- Expansion of the portfolio creates new partnership opportunities

Lyon, France, January 4th, 2018 – 6 pm CET – Adocia (Euronext Paris: FR0011184241- ADOC), the clinical biopharmaceutical company focused on developing innovative formulations of approved proteins for the treatment of diabetes and other metabolic diseases, today announced an update of its corporate strategy. The Company, which has built one of the most differentiated portfolio of injectable diabetes therapies, is expanding application of its proprietary BioChaperone® technology to new therapeutic areas.

“These two new projects that we introduce today, BioChaperone Teduglutide for the treatment of short bowel syndrome and BioChaperone Glucagon Exenatide for the treatment of obesity, are an excellent illustration of the great potential of the BioChaperone platform. Entering into new therapeutic areas creates additional partnering opportunities with different companies.” said Gérard Soula, Adocia President and CEO. “We also continue our efforts to partner our core diabetes programs, including the Phase 3-ready ultra-rapid insulin BioChaperone Lispro.”

Adocia’s proprietary BioChaperone technology is designed to deliver meaningful enhancement of single agents and enable the combination of multiple therapeutic proteins into a ready-to-use formulation. By improving the solubility and stability of therapeutic proteins and peptides in aqueous solution, BioChaperone has enabled the development a large portfolio of clinical and pre-clinical stage products, and has demonstrated safety and efficacy in multiple clinical trials.

Notably, BioChaperone has enabled the acceleration of the time action profile of a prandial insulin (BioChaperone® Lispro, ready to enter Phase 3), the creation of a ready-to-inject aqueous formulation of human glucagon (BioChaperone® Glucagon, Phase 1 completed) and the combination of previously non-mixable agents in a single aqueous formulation (BioChaperone® Glargine Lispro, Phase 2 and BioChaperone® Pramlintide Human Insulin, preclinical).

Adocia has built significant expertise through our focused work in injectable therapeutics for diabetes treatment” said Olivier Soula, Deputy General Manager and Director of R&D at Adocia. “BioChaperone technology has been shown in clinical trials to unlock important benefits for patients. We now see the opportunity to expand the use of BioChaperone to an array of proteins and peptides to bring meaningful, cost-effective innovation to other conditions with high therapeutic unmet needs.”

The first project to be announced as part of this expanded strategy is BioChaperone® Teduglutide. Teduglutide (Gattex®, Shire) is a GLP-2 analog approved for the management of short bowel syndrome as a once-daily injectable. It is currently marketed as a lyophilizate in a kit, requiring multiple reconstitution stages prior to each daily injection. By solubilizing and stabilizing teduglutide in an aqueous formulation, BioChaperone technology may deliver significant improvement to the daily life of people living with short bowel syndrome.

The second project announced today is BioChaperone® Glucagon Exenatide, a stable aqueous fixed-ratio combination of glucagon and exenatide for the treatment of obesity. It is based on BioChaperone Glucagon, the ready-to-inject formulation of human glucagon, for which positive Phase 1 topline results were recently announced by Adocia. Multi-hormonal approaches have recently been shown to hold promise for increased energy expenditure, significant weight loss and improved glycemic control in people with obesity[1].

Both programs are now in preclinical testing. Other pipeline candidates are currently under evaluation. Adocia will consider partnering opportunities at any stage of development of these assets.

The Company’s corporate presentation has been updated to include these new projects and is available on www.adocia.com.

About Short Bowel Syndrome

Short bowel syndrome (SBS) is a serious condition caused either by a congenital defect, intestinal infarction or extensive surgical resection of the intestinal tract, which results in a functional small intestine of less than 200 cm in length. In its more severe forms, SBS requires patients to receive parenteral or intravenous nutrition to compensate the effects of diarrhea, nutrient malabsorption, bowel dilation and dysmobility. Approximately 20,000 people with SBS in the US and Europe require parenteral nutrition[2]. In these people, Gattex® (teduglutide, GLP-2 analog, Shire) may be prescribed to improve intestinal absorption and reduce the need for parenteral nutrition, which severely disrupts the lives of patients. However, teduglutide is unstable in aqueous solution, and is only available as a lyophilized powder to be reconstituted daily prior to injection, which requires multiple steps. A ready-to-inject formulation should present significant advantages for people living with short bowel syndrome.

About Obesity

The worldwide prevalence of obesity (as defined by a body mass index ≥ 30 kg/m²) has tripled in the last four decades to reach 13% of adults in 2016[3]. In the USA, obesity affects 36.5% of adults[4]. Obesity is associated with serious co-morbidities such as cardiovascular disease, diabetes and non-alcoholic steatohepatitis (NASH), resulting in increased mortality and high healthcare expenditure. In the US, medical expenditure related to overweight and obesity were estimated to be $147 billion in 2009[5]. First-line therapy for obesity is diet and exercise, but it often proves insufficient to manage the condition. Several oral and injectable drugs have been approved to induce weight loss in people with obesity, but there is an important unmet need to significantly improve the lives of patients.

About Adocia

Adocia is a clinical-stage biotechnology company that specializes in the development of innovative formulations of already-approved therapeutic proteins and peptides. Adocia’s portfolio of injectable treatments for diabetes, featuring four clinical-stage products and six preclinical products, is among the largest and most differentiated of the industry. Adocia expanded its portfolio to develop treatments for obesity and short bowel syndrome.

The proprietary BioChaperone® technological platform is designed to enhance the effectiveness and/or safety of therapeutic proteins while making them easier for patients to use. Adocia customizes BioChaperone to each protein for a given application to address specific patient needs.

Adocia’s clinical pipeline includes four novel insulin formulations for the treatment of diabetes: two ultra-rapid formulations of insulin analog lispro (BioChaperone Lispro U100 and U200), a rapid-acting formulation of human insulin (HinsBet U100) and a combination of basal insulin glargine and rapid-acting insulin lispro (BioChaperone Combo). An aqueous formulation of human glucagon (BioChaperone Human Glucagon) successfully completed a Phase 1 trial. Adocia also develops a prandial combination of human insulin with amylin analog pramlintide (BioChaperone Pramlintide hIns), two combinations of insulin glargine with GLP-1 receptor agonists (BioChaperone Glargine Dulaglutide and BioChaperone Glargine Liraglutide), a ready-to-use aqueous formulation of teduglutide (BioChaperone Teduglutide) and a ready-to-use combination of glucagon and exenatide (BioChaperone Glucagon Exenatide), all of which are in preclinical development.

Adocia aims to deliver “Innovative medicine for everyone, everywhere.”

To learn more about Adocia, please visit us at www.adocia.com

For more information please contact:

Adocia
Gérard Soula
Chairman and CEO
contactinvestisseurs@adocia.com
Ph. : +33 4 72 610 610

Adocia Press Relations Europe
MC Services AG

Raimund Gabriel
adocia@mc-services.eu
Ph.: +49 89 210 228 0

Adocia Investor Relations USA
The Ruth Group

Tram Bui
t.bui@theruthgroup.com
Ph. : +1 646 536 7035

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