From Q1 Report 2022
The first quarter of 2022 has been intense for Initiator Pharma. With the Covid-19 pandemic slowing down dramatically, and less restrictions affecting our operations, we have seen good progress in all our current clinical programs; IPED2015, IP2018 and IPTN2021. During the quarter, and the following period, we have also strengthened the management team, signed an option agreement for an exciting new drug asset and announced a proposed capitalization which would secure the f inancing of our clinical program and the runway for Initiator into the beginning of 2024.
Dosing completed in the IPTN2021 program Phase I trial
Our clinical Phase 1 study to assess pain-reducing effects has, despite the still ongoing Covid-19 restrictions in the beginning of the year, progressed fully according to plan. The study, comprising 24 healthy male subjects challenged with the pain-inducing ingredient (capsaicin), dosed its first subject with the drug substance IP2015 in January. Almost exactly three months later, in April, we announced that all planned subjects have had the last visit in the study and all planned clinical activities had taken place. This is a major milestone for Initiator as this is the first clinical trial in our IPTN2021 program, that aims to target the treatment of the orphan drug pain indication trigeminal neuralgia using the drug substance IP2015. The trial will provide important pain related efficacy, biomarker and safety information to support further clinical development of the drug substance IP2015 in different indications. The obtained clinical data from the study will now be undergoing data management, quality and statistical analysis and we expect to be able to present the first results at the end of the second quarter. We are really looking forward to receiving the data and, if positive outcome, use it to design the next clinical study in the IPTN2021 program aimed at trigeminal neuralgia.
Potential pipeline expansion with a late-stage clinical asset
After the period, in the beginning of April, we announced the signing of an exclusive option agreement for a Phase 2/3 ready drug asset for an undisclosed pain indication. This drug candidate matches and complements Initiator’s current pipeline and ongoing clinical activities very well, including our other pain program IPTN2021, and furthermore strengthens our ambition of targeting the CNS for a broad range of indications. A major advantage with this late stage asset, and a prerequisite for a time and cost-efficient pathway to the market, is that it has already been de-risked to a high extent through previously conducted clinical studies, demonstrating exploratory clinical efficacy in the selected indication.
We are now initiating a deeper evaluation of the asset aiming to design a potential regulatory and clinical development plan that fulfills the Target Product Profile for the undisclosed pain indication. I look forward to sharing more information about the asset, the indication and terms after having completed the evaluation during the option period ending at year-end 2022.
IPED2015 and IP2018 clinical programs on track
Our most advanced program in erectile dysfunction (ED), IPED2015, is being evaluated in an ongoing Phase 2b trial conducted in the UK in collaboration with MAC Clinical Research. The patient recruitment rate is progressing well, and we still anticipate that inclusion and dosing of the planned 120 patients should be completed in the second half of this year.
The patient enrollment in our Phase 2a study with the monoamine reuptake inhibitor IP2018 in depressed ED patients, is still ongoing though the patient recruitment rate has increased significantly since we obtained approval from the regulatory authorities to modify certain inclusion criteria last summer. With the Covid-19 pandemic slowing down significantly we hope to be able to complete patient recruitment soon.
Proposed capitalization secures ongoing development and creates opportunities Initiator Pharma’s Board of Directors proposed in April a directed share issue and fully guaranteed rights issue of a total of approximately SEK 61 million in order to secure the long-term financing of the company and ongoing programs to the early part of 2024. This financing will be an important capital injection allowing us to advance all our clinical programs according to set plans and priorities. Furthermore, it also supports our business strategy of identifying attractive but undervalued clinical-stage assets and advancing these through cost-efficient clinical trials to deliver key-value inflection points in indications with significant unmet medical needs.
I am truly grateful for the continued trust shown by our anchor investors, Linc AB and Adrigo Asset Management AB, now even further shown by their significant increase in ownership in Initiator Pharma as a result of this proposed financing. Having two truly experienced and skilled anchor investors in our company is of immense value to us as management team and to all shareholders in the short as well as the long term.
The proposed directed share issue and rights issue is to be resolved on an Extraordinary General Meeting at May 18.
With a plan for secured financing, an attractive portfolio of clinical assets progressing according to plan, and our latest management team member Christina Guldberg onboard as Senior Director, Clinical Development and Outcomes Research (Rare Diseases), a new position designed to strengthen our clinical development and Orphan drug capabilities, I see the future with confidence and look forward to keep you updated on our progress.
Copenhagen, May 6, 2022
Claus Elsborg Olesen