Memorandum
Arecor recently announced securement of an additional £6 million (~$7.8 million) investment to move its preclinical diabetes portfolio (see table below) into clinical trials. Per the announcement, Arecor will bring its current portfolio into clinical development alone but will look to partner candidates for late stage clinical development and global commercialization.
Both of Arecor’s insulin candidates have been scheduled, on the company website, to begin human trials in 2018, and this funding should make that a reality, though we consider this a slightly ambitious timeline. However, Arecor is strongly positioned to become the first company to advance a U1000 mealtime insulin into clinical development.
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Candidate |
Competitive Landscape |
Status |
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Ultra-concentrated (U1000) rapid-acting insulin
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This product has been positioned (i) for patients with insulin requirements >200 units daily and (ii) as an ideal candidate for miniaturized delivery devices, including the artificial pancreas. It stands to become the first U1000 mealtime insulin to enter clinical development; Thermalin also has a preclinical U1000 candidate. Preclinical data demonstrating comparable onset of action and PK/PD profile to U100 insulin aspart (NovoLog) were presented at ATTD 2018. The candidate is based on insulin aspart. See our rapid-acting insulin competitive landscape for a comparison to other emerging candidates in this area. |
First in-human clinical trials are planned for 2018, as per product page. January 2018: Arecor completed JDRF-funded (≤$900,000 over 12 months) preclinical program (funding announced July 2016). We wonder if JDRF may invest further in this ultra-concentrated insulin candidate? |
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Arecor claims that its candidate has a PK profile with “considerably more rapid onset” compared to currently marketed rapid acting insulins. Preclinical data presented at ADA 2018 in comparison to an “ultra-rapid control composition including nicotinamide” (presumably Novo Nordisk’s Fiasp) indicate an improved PK/PD profile over currently-available rapid-acting insulins. See our rapid-acting insulin competitive landscape for a comparison to other emerging candidates in this area. |
Candidate has demonstrated preclinical feasibility and stability, and the first in-human clinical trials are planned for 2018, as per product page. |
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Reformulated commercially available glucagon for emergency injection (1 mg/mL) or use in an artificial pancreas (3-5 mg/mL). In pumps, the candidate is stable for a minimum of one week at body temperature and has a shelf-life of at least two years. See our glucagon competitive landscape for a comparison to other emerging candidates in this area. |
Currently in preclinical development; prototypes demonstrating injection and pump stability have been developed. |
Arecor’s announcement also references a preclinical pipeline of combination products for diabetes, and we’re curious as to what these candidates may be; to our knowledge, no info has been publicly released. The company’s product page remains cryptic beyond the three candidates above, briefly acknowledging that Arecor “is developing a number of undisclosed proprietary products within the diabetes therapeutic area.”
As background, Arecor uses its proprietary Arestat technology to reformulate existing products with improved functionality; the company details that its technology can increase stability in aqueous solutions, lower viscosity, and refine PK/PD profiles. Arecor previously had a biosimilar insulin glargine (Sanofi’s Lantus) with improved thermostability and ultra-long action, as well as a more thermostable liraglutide (Novo Nordisk’s Victoza) in development; these have both apparently been discontinued.
--by Peter Rentzepis, Ann Carracher, and Kelly Close