Adocia’s shares have soared this year on the back of positive proof-of-concept data for its ultra-fast-acting Humalog. Now the French company is on the hunt for a partner to replace Eli Lilly, which backed out of an alliance on the insulin last year.
Discussions have been had with big pharmaceutical companies, but the universe of potential collaborators could also encompass device companies because of the characteristics of BioChaperone lispro U100, chief executive Gérard Soula tells EP Vantage. “This is more important now with the development of the artificial pancreas. It is important to have a spike in terms of delivery of the insulin, with a quick in and quick out.”
Not just pumps
Use in closed-loop insulin pumps is not the only market on which Adocia is focusing, but it is the most intriguing now that something approaching an artificial pancreas has been approved in Medtronic’s MiniMed 530G (Therapeutic focus – Artificial pancreas projects will deliver over time, October 4, 2013).
The more pressing need perhaps is for mealtime insulin that can control damaging blood-sugar spikes when the ingestion of food is unpredictable. Dosage of so-called prandial insulins like Humalog, Novolog or Apidra must be timed to coincide with the start of a meal – or sometimes up to 15 minutes before – which is a particular problem for parents with diabetic children.
The fact that the recently approved Afrezza can be taken right as a meal begins is perhaps one of its selling points, but it is only indicated for adults, leaving other projects to deal with the issue of children who may not eat exactly 15 minutes after an insulin injection. Indeed, Mr Soula notes that the data indicate that BioChaperone lispro U100 may keep blood sugar under control even if taken after a meal.
The phase IIa data reported a month ago found the Adocia insulin reached peak concentration more quickly and cleared the bloodstream more quickly than Humalog in type 1 diabetics, an effect that more closely duplicates the behaviour of endogenous insulin, according to Adocia. Type 1 diabetes destroys the insulin producing capacity of the pancreas through an autoimmune reaction, necessitating insulin therapy early in the disease progression.
Following the results, shares more than doubled over the course of September and the Lyon-based group ended the month at €37.55, making it one of the small-cap winners for the third quarter (Acquisitions help define performance of mid and small cap stocks, October 6, 2014). Shares have fallen back some since then, although they still stand well above their €16.04 float price in February 2012. The company is valued at €178m ($226m).
Type 1 diabetics constitute a minority among diabetics, just 5% in the US. Adocia has a second ultrafast product for the bigger type 2 market: Lispro U300, which is tilted toward overweight patients and those with severe insulin resistance. This product has 300 IU/mL to the 100 IU/mL of the type 1 product and is slated to enter its first phase I/II programme next year.
Both insulins, along with a human insulin product called HinsBet and a product that is both ultrafast and long-acting, built around Lantus, are based on a technology called BioChaperone that protects the active proteins against enzymatic degradation.
The BioChaperone technology was the foundation of the now-terminated Lilly collaboration, which Mr Soula says was terminated because of a disagreement over how quickly to progress studies after satisfactory results in healthy patients. “They were not prepared to move the product into diabetic patients and to speed up the project,” he says.
That leaves only two major insulin players as potential partners: Sanofi, maker of Lantus and Apidra, and Novo Nordisk, maker of Tresiba and NovoLog. HinsBet has greater potential for snaring an alliance outside of the insulin oligopoly as it is a developing nation play: “We can make human insulin as fast as lispro but at the price of human insulin,” Mr Soula says.
Adocia closed out the first six months of 2014 with €16m ($20m) and today has sufficient cash for a full year of operation, which will include preparing the necessary documents and clinical plan for advancing into phase III. Mr Soula believes that in that time the big insulin players will come calling because of their need to stay ahead of biosimilar competition - indeed, the big insulin players themselves are preparing to launch biosimilars.
“All their franchises are in danger,” he says. “If they want to maintain their position they need innovation.”
The sign that Adocia’s technology represents the innovation the insulin giants need will be a signed licensing agreement.