February 2023 Newsletter

InsuLife, a Norwegian-based company dedicated to revolutionizing the insulin market by developing a transdermal spray, today provides a business update on recent and ongoing activities.

Manufacturing and analysis chain established in Oslo, Norway
As part of the company’s efforts to develop its investigational spray-on-skin insulin solution, InsuLife spent the last six months of 2022 establishing a manufacturing chain for its investigational medicinal product, LevellorTM. InsuLife has worked closely with its selected manufacturing partner, Pharma Production AS in Oslo, which offers expertise, governance and approved pharmaceutical manufacturing facilities. InsuLife has also entered into an agreement with Vitas AS as its external laboratory analysis partner to ensure that the quality of the drug substance and formulation meets the highest standard of pharmaceutical manufacturing.

Outsourcing manufacturing and analysis to partners of the highest quality ensures cost-effective and flexible manufacturing and takes away the need for investment in facilities and people; thus keeping the InsuLife burn rate low.

Clinical trial preparations are underway
InsuLife had targeted to commence its clinical phase 1 / 2a trial in the spring of 2023, but due to delays in obtaining sufficient drug stability data, the trial is now expected to take place in the autumn of 2023. The company has finalized the clinical trial protocol, which was completed in close cooperation with Clinical Trial Consultants AB, the clinical trial site in Sweden.

InsuLife is now in the process of compiling all the required documentation to submit an Investigational Medicinal Product Dossier (IMPD) and Investigator Brochure (IB) as part of a Clinical Trial Application (CTA), which will be submitted to the new European Medicines Agency Clinical Trials Information System. The application review process will take 95 days as of the submission date.

The clinical phase 1 / 2a trial
The study is a phase 1 / 2a open-label, single dose, 3-period, cross-over, euglycemic clamp study of pharmacodynamics, pharmacokinetics, safety and tolerability of transdermal recombinant human insulin spray (Levellor™) in patients with type 1 diabetes mellitus following a phase 1 pilot study of escalating single doses of transdermal recombinant human insulin spray (Levellor™) in healthy subjects to explore skin irritation and overall safety and tolerability.

Åge Nærdal, Chief Executive Officer, InsuLife, commented: “We are working diligently to progress our transdermal insulin spray into the clinic as rapidly as possible. Despite the delay in commencing the study, we are confident that the study will take place in 2023. We have also come a long way in establishing an outsourced manufacturing facility and quality control in Oslo, which is the first of its kind. Whilst we work to gather the necessary documentation to submit the CTA, we will continue to develop the business and proactively meet with prospective partners and investors.”

Results of market survey
In February, InsuLife conducted a survey amongst 400 people in the US and UK with diabetes who administer insulin via injection (vials, syringes and insulin pens). The aim of the survey was to gain a better understanding of people’s views and whether they want to potentially administer their insulin with a spray-on-the-skin solution. As many as 75 percent of the responders answered they would be ‘highly likely’ to try a transdermal insulin spray if recommended by their doctor. Overall, the results of the survey support our efforts to develop a transdermal insulin spray.

Selected responses from the survey:

• “This is a wonderful initiative I am often embarrassed when injecting needle of insulin in the public, and it’s not convenient to use.” (ref. a respondent).
• “The spray will be the easiest so far, you don't have to deal with needle on your body every day, just spray and you will be good to go.” (ref. a respondent)

Preparations for pre-IND meeting with the US Food and Drug Administration (FDA)

With the establishment of InsuLife Inc. in the USA, we have started preparations for undertaking a pre-IND (Investigational New Drug) meeting with the US FDA. This is an advisory meeting that provides an understanding of clinical development requirements towards a marketing authorization application in the US.

Karen Quinn, InsuLife Head of Regulatory Affairs, is currently gathering all documentation and information on our investigational medicinal product into IND documentation standards.

Additionally, InsuLife is working on a clinical trial protocol for the first clinical trial in the USA. This is set to follow and extend the clinical trial taking place in Sweden. This clinical trial protocol will be finalized based on advice and input from the pre-IND meeting with FDA.

Increased exposure having attended several scientific and industry conferences

Since the fourth quarter of 2022 and the beginning of 2023, the InsuLife team has actively participated in renowned scientific and industry conferences.

• In December 2022 InsuLife attended the annual International Diabetes Federation Congress, where several important topics concerning diabetes were discussed, such as restricted access to insulin, affordability and the experiences of diabetes patients around the world. Having engaged with several diabetes patient associations representing different countries, the company has received positive and encouraging feedback concerning its potential transdermal insulin spray.
• In January 2023, the company participated in the Biotech Showcase, part of the J.P. Morgan Health Care Conference in San Francisco, one of the largest healthcare investment conferences in the industry. The team was encouraged by the enthusiasm displayed by potential future partners and investors through individual meetings.

• The company also attended PharmaPack 2023 in Paris, France, the European hub for the pharma packaging and drug delivery device industry. The team gained invaluable insight into product packaging, which will be important for the development of InsuLife’s future product design. A key theme at the conference was the focus on sustainable packaging and the increased focus on the patient experience, especially for patients living with chronic diseases requiring daily administration of medications, such as patients living with diabetes.

IPO readiness

As previously disclosed, the company is considering a stock exchange listing. InsuLife has met with relevant investment banks and is in the process of implementing internal processes to ensure IPO readiness and good governance, which also includes successfully completing the planned phase 1 / 2a clinical trial study. The company will keep its shareholders updated on developments as and when they occur.

To learn more about InsuLife’s potential transdermal spray technology, click here, to watch InsuLife’s Chief Science Officer, Dr. Chandan Alam, discuss how insulin molecules can enter through the skin.

Enquiries:

InsuLife
Åge Nærdal, Chief Executive Officer
Email: info@insulife.no

About InsuLife

InsuLife 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, 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 it is estimated that more than 750 million people with be living with diabetes in 2045 (IDF Diabetes Atlas 2021).
Read more at www.insulife.com.