Clinical Trial Supply Agreement – Cementing the Preparedness for Clinical Trials
Since our last update, InsuLife signed a Clinical Trial Supply Agreement with a large global pharmaceutical company. This significant agreement implies that InsuLife will be on the receiving end of free insulin to be used for clinical trials. In exchange, this global pharmaceutical company will be entitled to an exclusivity period to negotiate a commercial deal with InsuLife once results from the first clinical study are available.
Moving into the Stability Testing phase
With issues concerning the utilization of HPLC methods described in insulin monographs solved, InsuLife is ready to initiate stability testing of the INS-2301 insulin formulation. The testing will start as soon as InsuLife receives insulin from its new partner in the early autumn.
Clinical Development Plan Being Firmed Up
As mentioned in the previous newsletter, InsuLife was planning to attend a pre-IND meeting process with the US FDA to understand clinical development requirements towards marketing approval in the US. The pre-IND process took place in June, and InsuLife had the opportunity to present the high-level and overall clinical plan.
InsuLife has since then received feedback from the US FDA, which clearly describes its requirements for a future potential approval for INS-2301 in the US. Notably, the feedback strongly supports InsuLife’s plan to initiate the clinical program with a euglycemic clamp study to investigate the pharmacokinetics and pharmacodynamics of INS-2301 compared to subcutaneously injected insulin. With this feedback on board, InsuLife will develop updated and solid timelines for future clinical studies.
InsuLife is evaluating its options for performing the first clinical trial in Europe and the US. In Europe, the European Medicines Agency has a handling time of 4 months for Clinical Trial Applications. Thus, cost, timing and quality of study sites will be considered before deciding where the first study will be conducted.
Proof-of-Principle Shown in Rat Study
A study in rats undertaken in 1st half of 2023 has successfully shown that Human insulin applied to the skin of rats can transmigrate into the bloodstream of diabetic rats with a peak plasma human insulin detected at ~30-60min post-application.
Additionally, the study showed that transdermal insulin dose-dependently reduces blood glucose levels in diabetic rats at both 2 and 4 IU/kg doses and showing continuous blood glucose reductions throughout the 8 hours measurements.
Successfully Completed Bridge Fundraising from Existing Shareholders
Towards the end of the first half of 2023, InsuLife invited existing shareholders to participate in bridge funding. The interest we received from shareholders was overwhelming, and from initially seeking to raise NOK 3 million, InsuLife raised NOK 6 million. The bridge funding share price was NOK 5.00 per share, up from NOK 3.00 per share in the summer of last year. The funds will be used to finalize method validation for insulin analysis in INS-2301, manufacture the product and start stability testing of INS-2301. With this foundation, InsuLife is currently in several fundraising processes with interested parties to secure financing of the execution of the imminent clinical trial. The current fundraising activities target to raise up to USD 10 mill.
Åge Nærdal, Chief Executive Officer
IInsuLife is a pioneering private company based in Norway. InsuLife is dedicated to transforming the way in which insulin is administrated by diabetes patients by developing its unique transdermal spray, INS-2301 (formerly termed Levellor™). A transdermal insulin spray has the potential to replace needle-based administration of insulin for diabetes patients looking for alternative administration methods. Today, 537 million people live with diabetes worldwide and according to estimates released by the Lancet Medical Journal in June 2023 more than 1.3 billion people worldwide will have diabetes in 2050.
Read more at www.insulife.com.