Adocia (EPA:ADOC) has brought its Eli Lilly ($LLY)-partnered fast-acting insulin BioChaperone Lispro through another early test. Data from the Phase Ib trial, which was the first time repeated doses of the drug have been given in an outpatient setting, add to evidence that BC Lispro can outperform Lilly's Humalog in terms of postmeal blood glucose control.Adocia CEO Gérard Soula
Lyon, France-based Adocia administered either BC Lispro or Humalog to 36 Type I diabetics at the time of their meals over two 14-day periods. The effect of the drugs was tested at the start and end of the periods. On day one, patients in the BC Lispro arm experienced a 31% drop in blood glucose compared to Humalog in the two hours after injection. By day 14 of the trial, the gap between the two drugs had widened to 42%. Adocia is hoping the steeper decline associated with BC Lispro will give diabetics more flexibility in exactly when around their mealtimes they inject an insulin analog.
The firm now has data from a pair of Phase Ib trials suggesting this is the case. In the earlier Phase Ib study, the difference in the performance of BC Lispro and Humalog was more pronounced than in the latest trial, but the new results add another angle to Adocia and Lilly's data set. "This was an important study and provides our first experience with repeat doses of this ultrarapid insulin formulation in an outpatient setting," Dr. Thomas Hardy, senior medical director at Lilly Research Laboratories, said in a statement. "We are encouraged by these results."
Adocia and Lilly have more data to come. The outpatient study was one of four Phase I trials kicked off by Adocia and Lilly in the months after the pair unveiled the original data showing BC Lispro could best Humalog. Within six weeks of submitting the outpatients trial to ClinicalTrials.gov, Adocia had sent in details of a study in patients with Type II diabetes and another that is administering BC Lispro by continuous subcutaneous insulin infusion. A fourth trial in Japanese patients got underway at the start of this year.
The raft of Phase I trials are designed to furnish Adocia and Lilly with the data they need to take BC Lispro into Phase III. If BC Lispro advances to that stage and beyond, Adocia will pick up more and more of the $280 million (€252 million) in development and regulatory milestone payments Lilly committed to when it secured the rights to BC Lispro late in 2014.
- read the statement (PDF)