Adocia Expands Clinical Development to Obesity with Patent Applications on Short-Acting Multihormonal Combinations Administered by Pumps

• Three patent families have been filed to cover novel hormonal combinations: pramlintide-exenatide and glucagon-exenatide – both combinations demonstrated promising effects in obesity treatment

• Administering short-acting hormones by a pump empowers the patient, who can optimize the benefit/risk ratio of their treatment

• These formulations could also be developed for the treatment of other metabolic diseases such as NASH (Non-Alcoholic Steato-Hepatitis), type 2 diabetes or neurodegenerative diseases
  

LYON, France, May 26, 2021 (GLOBE NEWSWIRE) -- Adocia (Euronext Paris: FR0011184241 – ADOC), a clinical-stage biopharmaceutical company specialized in the development of innovative formulations of proteins and peptides announced today that three patent families have been filed for the treatment of metabolic diseases including obesity, NASH (Non-Alcoholic Steato-Hepatitis), type 2 diabetes and neurodegenerative disorders. These patents relate to combinations of short-acting hormones administered via pump. First preclinical results obtained in obese mice population by a combination of glucagon-exenatide (BioChaperone^® GluExe) show a weight loss of 25% versus 15% with exenatide alone after 14 days of treatment¹. A second combination of pramlintide and exenatide (PramExe), currently in development, also presents promising properties. The pumps used are those already marketed for insulin therapy, and in particular patch-pumps, which are easy to use and suitable for this purpose. The user can adjust the maximal tolerable dose and therefore optimize the benefit/risk balance.

"We want to establish a new therapeutic paradigm for chronic diseases such as obesity, allowing patients greater control over their treatment,” explained Gérard Soula, Adocia’s CEO. "Our vision is to empower people by helping them to regain control of their illness, by enabling them to adjust doses in real time with the help of modern pumps and connected devices for better adherence to long-term treatments. This is where the future is heading: personalized medicine and patient empowerment.”

Adocia is offering a disruptive therapeutic approach by infusing short-acting hormones via a pump so that patients can easily and quickly adjust the doses administered, in contrast to the current way of thinking which is to extend the duration of action of hormones to offer weekly injections. One of the disadvantages of long-acting hormones is the impossibility to interrupt the side effects - particularly gastrointestinal - which can sometimes last several days after administration. Pharmaco-epidemiological studies on the use of once-weekly GLP-1 hormones in type 2 diabetes reveal that 48.0% of patients stop treatment after one year, while 73.2% stopped after two years².

Pump-infusion opens a number of perspectives:

• The patient can gradually increase the dose as recommended when initiating these hormonal treatments

• The continuous infusion allows patients to maintain weight loss effect without concentration peaks that could cause side effects

• The patient can stop and start the treatment at the touch of a button; side effects decrease rapidly due to the short-acting hormones, treatment can be resumed quickly once these effects have subsided

• The patient has the freedom for a “day-off”, to momentarily pause treatment for greater flexibility on professional or personal occasions, improving quality of life

• Algorithm development and machine learning could also improve treatment efficacy and tolerance
  

“Our expertise on diabetes hormones and the potential of insulin pumps led us to expand applications to other chronic diseases,” comments Olivier Soula, Deputy CEO and Director of R&D at Adocia. "Our next objective is to establish clinical proof-of-concept with good tolerance and efficacy of PramExe administered via pump, while being well-accepted by people suffering from obesity."

PramExe is a fixed-ratio co-formulation of an amylin analog (pramlintide) and a GLP-1 receptor agonist (exenatide). Pramlintide and exenatide are two hormones marketed for the treatment of diabetes and have already demonstrated separately positive effects on weight loss and satiety. Adocia’s innovation lies in combining weight loss effects of these two compounds administered with a wearable pump. Adocia’s PramExe combination is ready to be clinical tested in humans.

About obesity and treatments

More than 650 million people worldwide, are obese (BMI≥30 kg/m²) according to the official classification of the World Health Organization (WHO), which declares obesity a chronic disease and a major public health problem since 1997². According to the WHO, 2.8 million people die each year worldwide as a result of being overweight or obese. Currently only 2% of patients suffering from obesity are medicated³ and only hormonal treatments appear as a possible alternative to bariatric surgery.

About Adocia

Adocia is a clinical-stage biotechnology company that specializes in the development of innovative formulations of therapeutic proteins and peptides for the treatment of diabetes and metabolic diseases. In the diabetes field, Adocia’s portfolio of injectable treatments is among the largest and most differentiated of the industry, featuring five clinical-stage products and several pre-clinical products. 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.

Adocia’s clinical pipeline includes four novel insulin formulations for prandial treatment of diabetes: two ultra-rapid formulations of insulin analog lispro (BioChaperone^® Lispro U100 and U200), a combination of basal insulin glargine and rapid acting insulin lispro (BioChaperone^® Combo) and one combination of a prandial insulin with amylin analog pramlintide M1Pram. The clinical pipeline also includes an aqueous formulation of human glucagon (BioChaperone^® Glucagon) for the treatment of hypoglycemia.

Adocia preclinical pipeline includes bi-hormonal combinations for diabetes treatment: two combinations of rapid acting insulin analogs and Pramlintide (BioChaperone^® Lispro Pram and BioChaperone^® Aspart Pram), a combination of insulin glargine with GLP-1 receptor agonists (BioChaperone^® Glargine Liraglutide). In addition, there are two bi-hormonal products for the treatment of obesity: a combination of glucagon and exenatide (BioChaperone^® GluExe) and a combination of pramlintide and exenatide (PramExe).

Adocia recently added a preclinical program to its pipeline with a cell therapy initiative focused on development of a hydrogel scaffold for use in people with type 1 diabetes. The first patent application supporting this program has been filed.

Contact Adocia

Adocia Gérard Soula CEO contactinvestisseurs@adocia.com Ph: +33 4 72 610 610 www.adocia.com	MC Services AG Adocia Press Relations Europe Raimund Gabriel Managing Partner adocia@mc-services.eu Ph: +49 89 210 228 0	The Ruth Group Adocia Investor Relations USA James Salierno Vice-President jsalierno@theruthgroup.com Ph.: +1 646 536 7035

Disclaimer

This press release contains certain forward-looking statements concerning Adocia and its business. Such forward-looking statements are based on assumptions that Adocia considers to be reasonable. However, there can be no assurance that the estimates contained in such forward-looking statements will be verified, which estimates are subject to numerous risks including the risks set forth in the “Risk Factors” section of the Universal Registration Document filed with the French Autorité des marchés financiers on April 20, 2021 (a copy of which is available at www.adocia.com) and to the development of economic conditions financial markets and the markets in which Adocia operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Adocia or not currently considered material by Adocia. The occurrence of all or part of such risks could cause actual results, financial conditions, performance, or achievements of Adocia to be materially different from such forward-looking statements. This press release and the information contained herein do not constitute an offer to sell or the solicitation of an offer to buy Adocia shares in any jurisdiction.

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¹ 2019 ADA - poster presentation, 7/11/2019

² https://www.who.int/News-Room/Fact-Sheets/Detail/Obesity-And-Overweight

³ Novo Nordisk 2020 Annual report