The Phase IIb/III study is now running on two continents, in the US and Europe. It is great that European sites have now started recruiting and treating patients in this multinational study, maintaining a good recruitment pace. More countries will follow in the coming months.
This application of AI methodology to our ISP database yielded stable results supporting the use of deep learning as a valuable addition to the machine learning methods we use in our proprietary research platform ISP, Integrative Screening Process. The ISP technology is key to the rapid and successful discovery and development of our clinical candidates mesdopetam and pirepemat. Enhancing the precision in our methodology further improves quality and contributes to increased competitive advantage for IRLAB and our drug candidates.
These exciting and important new results from preclinical studies increases the potential benefit of mesdopetam treatment in Parkinson's disease substantially, since we now see the possibility not only to treat already established dyskinesia, but also to prevent the occurrence of dyskinesia. To prevent the development of disease symptoms has long been a goal in science, hitherto not reached.
After a successful year with an IND approved in the Unites States, the start of the phase IIb-study with mesdopetam and the listing on Nasdaq Stockholm main market, IRLAB will enter 2021 with a strengthened financial position. An increased institutional ownership and additional cash give us the prerequisites to continue to develop the company at a higher pace
The capital injection gives us the opportunity to increase the pace of our clinical studies and accelerate the preparations for phase III-studies, all to minimize the time to launch of completed pharmaceuticals. Both the mesdopetam and pirepemat-programs address great medical needs, with substantial potential benefits for patients and other interested parties.
The now published patent application is part of our continuous strategy to strengthen the intellectual property around our drug candidates, development portfolio and innovations. If this new patent application is granted in the forthcoming national application phases, exclusivity for mesdopetam may be protected by two strong patent families into the 2040s, benefitting patients and other stakeholders.
Patient recruitment started four weeks after FDA acceptance of the IND for mesdopetam, which is a testament of the team’s diligent work. Mesdopetam can make a big difference for Parkinson's disease patients. We now take additional important steps towards our goal to offer efficient treatment.
We are pleased to receive acceptance of the IND. The FDA clearance of the IND is a quality stamp on the mesdopetam project and validates mesdopetam as a safe and tolerable drug candidate. It also means that we now expand our clinical development operations to the US, an important strategic goal for the company. We believe that mesdopetam has a very good chance to offer a completely new and better treatment for the large group of Parkinson’s patients experiencing daily complications and reduced quality of life due to levodopa-induced dyskinesia.
The treatment effects seen in the previous Phase IIa study exceeds the results for other treatment strategies in troublesome dyskinesias. When mesdopetam was given in addition to standard Parkinson medication, patients experienced considerably longer periods of good daily motor function without aggravated involuntary movements improving the daily function in these severely affected patients. This is highly relevant since involuntary, levodopa-induced dyskinesia is a major problem In Parkinson's disease today preventing optimal individual treatment.
This is an important day for us. Moving to Nasdaq Stockholm's Main Market is an important milestone in our growth journey. The support from existing shareholders and the welcoming of new shareholders on the main market will enable us in our mission to transform everyday life for patients with Parkinson’s disease.
The listing of IRLAB on Nasdaq Stockholm Main Market entails increased visibility and transparency and is a quality seal on our organization and operations. In our opinion, this is a significant step towards becoming an internationally reputable drug development company.
This is the second time in recent months that we have seen one of our drug candidates on the front cover of the top ranked scientific journal JPET. This signals the strength and originality in IRLAB's research and in our drug candidates, and represents yet another validation of our unique discovery platform, ISP. To publish scientific papers in peer reviewed journals is an important channel to create international awareness of our advancements in research and the results from our clinical studies.
IRL752 is the second drug candidate from our pipeline that in a short time has been considered to be unique enough to propose a new classification of the drug candidate and future drug. This is yet another confirmation of the innovative power of IRLAB and our research platform, ISP. This also supports our vision to develop novel and innovative drugs with the potential to not only improve but rather transform the treatment of Parkinson’s disease. Our goal is to make a substantial difference for patients and their families with innovative novel therapies.
This paper was the result of a successful cross-disciplinary collaboration between scientists at IRLAB and an academic research group in the UK. To share our research within an international network and explore the potential of our drug candidate in a renowned independent lab, specialized in studies of cognitive processes, is significant for us. I would also like to emphasize the importance of these scientific findings for the continued clinical development and, ultimately, the change we hope IRL752 will bring to affected patients and their caregivers.
We are proud that IRLAB by means of our systems biology discovery strategy, ISP, has discovered and developed a candidate drug that is now featured on the cover of the prestigious scientific journal JPET. It is rewarding that IRLAB receives such an acknowledgement.
When mesdopetam was given in addition to standard Parkinson medication, patients experienced considerably longer periods of good daily motor function without aggravated involuntary movements. This is highly relevant since involuntary, levodopa-induced dyskinesia is a major problem in the treatment of Parkinson's disease preventing optimal treatment. Mesdopetam represents a new approach that, by inhibiting the mechanisms in the brain that has the most impact on levodopa dependent development of troublesome dyskinesias, and thus, can prevent these, improving the daily function in these severely affected patients.
The treatment effects seen in our Phase IIa study exceeds the results published for other treatment strategies in troublesome dyskinesias. We believe that mesdopetam has a very good chance to offer a completely new and better treatment strategy for the large group of Parkinson’s patients with levodopa induced dyskinesia. The strategy planning for the Phase IIb/III-study with mesdopetam in Parkinson’s disease is now completed. We have recently also secured financing for the study and initiated a collaboration with a highly reputable CRO.
The two papers now published in JPET add to the growing body of data supporting mesdopetam as a very promising drug candidate for the treatment of both motor and psychiatric complications in Parkinson’s disease. Furthermore, the study adds to the increasing number of scientific publications indicating a significant role for the dopamine D3 receptor as a drug target in Parkinsons disease
We now have two drug candidates with new mechanisms of action that have delivered very positive results in Phase IIa studies for Parkinson’s; This confirms the power of innovation in our research platform ISP. We are now entering the “develop for launch” phase with mesdopetam and IRL752 and continues the development of our preclinical projects toward Phase I studies.
External validation of our research and drug development is important. Publication of clinical study results in such a highly ranked journal as Movement Disorders is central in the development of IRL752 and considered a milestone for the company. The aim with IRL752 is to improve balance and reduce the risk of falls in patients with Parkinson’s disease, which is the current top priority within the treatment of Parkinson’s disease.
We are very pleased with the strong support from both existing and new shareholders in this rights issue. In combination with the directed share issue, concluded in December last year, we now have the financial resources to start and conclude the two planned Phase IIb studies in Parkinson’s disease with mesdopetam (IRL790) and IRL752, respectively. In addition, we now have the necessary prerequisites to finalize the process to move to Nasdaq Stockholm Main Market.
It is gratifying that IRL790 has been recommended the name mesdopetam, which emphasizes that it is a first-in-class substance with a new mechanism of action and has the opportunity to become the first in a completely new class of drugs for the treatment of complications in Parkinson’s disease. Mesdopetam has a unique mechanism of action, indicating that a treatment based on the substance can bring better and other therapeutic effects than current drug classes and thereby add value for patients and healthcare systems. The fact that WHO shares our assessment of the uniqueness of mesdopetam is a confirmation that IRLAB is successful in discovering and developing innovative drug candidates.
We are pleased for the large interest to participate in the capital raise, which gives us the opportunity to bring IRL790 and IRL752 through the next step in the development towards registration. Both IRL790 and IRL752 have potential to achieve important improvements for the growing group of patients having Parkinson’s disease. The capital raise also gives us conditions to finalise the move to the Nasdaq Stockholm main list.
Being granted patents for IRL942 and IRL1009 is a significant demonstration of the power of innovation that lies within our research platform ISP. Independently, two of the world’s key patent authorities have deemed that also these ISP derived candidates fulfill criteria such as novelty, inventive step and industrial applicability.
The SfN Neuroscience conference is the most impactful conference for neuroscientists across the globe. It’s important for IRLAB to be present at these types of congresses to show and discuss our research within the medical community. Not only does the audience consist of leading experts and researchers in the field but also some of the key pharmaceutical companies in the world.
In the INN system, the relationship between pharmacologically-related substances is identified through the use of a common stem. Only when substances show a novel mode of action, which is rather rare, a new INN stem is established. Therefore, we are very pleased to have been proposed the unique “-dopetam” ending for IRL790, which may become a stem in the future. This would underline the candidate’s position as a potential first-in-class treatment of Parkinson’s disease.
Prof. Svenningsson is an outstanding researcher and we are glad to be working closely with him. It is great to get this type of recognition in the medical community and it is a privilege to be selected to present at the congress, which also means that our data caught the interest of the congress committee among many other abstract submissions.
I think that the study shows a strong efficacy signal for IRL790 in treating dyskinesia in people with Parkinson’s, using measures that are of relevance to them, and importantly with very few adverse events. These findings need to lead to larger studies, to more clearly evaluate the efficacy, and hopefully lead to a much-needed additional therapy for this disabling side-effect of levodopa therapy.
IRLAB has now concluded an in-depth analysis of the Phase IIa study data that further substantiates the potential for IRL790 to improve treatment of L-dopa induced dyskinesia. We have gained a deeper understanding of the results, including pros and cons of the independent measurement methods used in the study, and are now able to optimize the clinical path forward. The next step will be initiation of a Phase IIb/III study in this severely troubled patient group, which can be part of the pivotal program. The planned study in Parkinson’s disease psychosis will be performed in parallel with the final studies in the LIDs program. This does not delay the total program.
In patients with advanced Parkinson’s disease, IRL790 treatment improved the motor function response with a marked qualitative shift in ON-time towards more ‘good ON hours’, without troublesome dyskinesia or adverse effects. This beneficial shift in motor response quality was even more pronounced in patients not taking amantadine. This amantadine interaction is a very important discovery from a therapeutic perspective. In order to demonstrate the true efficacy of IRL790 this will be considered when designing coming clinical studies.
Dyskinesia is a burdensome symptom for patients with Parkinson’s disease as it is affecting their everyday lives and limits optimization of L-Dopa treatment. The patient reported outcome in this study suggest that adding IRL790 to their otherwise stable anti-parkinsonian treatment can improve the quality of daily motor function by reducing troublesome dyskinesias. This outcome was also independently reflected in the UPDRS ratings but not in the UDysRS ratings. This discrepancy needs to be investigated further. Importantly, the excellent safety and tolerability profile observed for IRL790 treatment in this study provides additional reassurance that IRL790 is safe to use in this vulnerable patient population and supports a careful assessment of the continued clinical development of IRL790.
We are pleased that the study is completed. Given the ambiguity between UDysRS and the other two methods used to assess dyskinesias, further analyses aiming to clarify the underlying reasons will be prioritized to optimize the clinical path forward. Next planned clinical study with IRL790 is in psychosis associated with Parkinson’s disease, PD-P, while continuing CMC development and long-term toxicological studies.
We are pleased to see that investments at the national level is made into research about Parkinson’s disease, its causes and treatment, where there is a great need for deeper understanding and novel therapies. It is an honor for us to work together with such reputed academic partners as Per Petersson and Per Svenningsson and their teams, we look forward to this collaboration.
This is the company’s second successfully completed patient recruitment in a clinical Phase II trial in Parkinson’s disease. After intensified efforts of supporting patient recruitment during the past months, it is rewarding to see the effects of the work. We are now looking forward to completing the treatment phase of this study and receive the results.
We are currently working to reach our main objective of completing the clinical proof of concept for IRL790. This Phase II study is the first step. The next study for IRL790, a Phase II study in Parkinson’s disease patients with psychosis, is planned to be initiated later this year.
It is a significant milestone to receive the DSMB’s opinion at this point in the ongoing study. Additional patients have completed treatment without safety issues, which is key in a successful study.
We maintain a strong focus on recruitment and have introduced measures to speed up recruitment, both in the UK and by adding Swedish sites to the program. We note that these measures while being prudent, are having a positive effect.
We are pleased with the informative meeting with the FDA, and can now confirm that an IND-application for IRL790 will not require any additional non-clinical data or CMC work to support the next Phase II clinical study. This is one of many important milestones that we have methodically ticked off advancing IRL790’s clinical development program.
The independent Data and Safety Monitoring Board’s stated after their first review, that there were no safety concerns in the ongoing Phase IIa study with IRL790, indicating that we have chosen to study the right dose range. Furthermore, we are also pleased to see the increase in recruitment pace in the study. As we are closing the year, we can conclude that we have made significant progress across both our clinical programs and the preclinical R&D work. With these achievements, we look forward to continue the advancement of our project portfolio during 2019.
Our study is now published in the journal npj Parkinson's Disease. This validates the research and is, of course, a major merit for IRLAB, our partners and the study's investigators.
We continuously work to improve our products and we apply for patents for our inventions. This work, when patents are granted, leads to strengthened protection around our research projects and drug candidates. If this new patent application for IRL752 is approved in the forthcoming national application phases, IRL752 may be protected by two strong patent families until the end of the 2030s or longer.
The nomination of the two new candidate drugs and the update clarifies that IRLAB focuses on IRL790 and IRL752 and utilizes our competitive advantage following the positive results in initial clinical trials. The new drug candidates are intended to complement the IRL790 and IRL752 projects with a strong commitment in Parkinson’s disease.
It is very rewarding that we, as a young company, have the ability to strengthen our pipeline with a new research program while nominating two more promising drug candidates in one of our ongoing projects. Our research organization has once again demonstrated the efficiency of the ISP platform.
This is an important step in our P001 discovery program and for the pursuit of the next generation of compounds effectively treating patients suffering from motor, psychiatric and cognitive disorders. We are confident that this patent will strengthen our intellectual property portfolio, enable the selection of new drug candidates, and boost our continuing effort developing improved treatments of CNS disorders.
It is promising that our candidate drug IRL752 seems to improve symptoms and signs characteristic to this patient group. Falls, impaired balance and apathy are difficult to treat and are associated with impaired cognitive function in Parkinson's disease. The results will facilitate the design of a longer duration Phase IIb study, which will be aimed at investigating efficacy of IRL752.
There is a great need for treatments of the symptoms IRL752 seems to affect. It is now important to confirm these encouraging results in a larger study.
We have now completed a first study with IRL752 in patients with Parkinson's disease and dementia. We are pleased that IRL752 was well tolerated. The results of the study give us valuable information for the further development of IRL752.
The results indicate that IRL752 targets the central nervous system and appears overall safe to use in persons with Parkinson´s disease and dementia, a common cause for nursing home placement. It will be important to proceed with larger trials with IRL752 for this patient group in the near future.
We are proud to have attracted a top tier US health care investor, three Swedish pension funds and highly renowned Swedish investors, all with deep knowledge of the pharmaceutical sector. It highlights the potential in our research platform and in our clinical programs. This is a milestone for IRLAB and provides even better conditions for us to continue to develop safe and effective treatments for unmet needs in Parkinson’s disease and other disorders of the brain.
The feature of ISP by Biomedical Advances highlights that IRLAB is at the forefront of contemporary science. The brain, and disorders of the brain are complex and innovative approaches are needed to discover and develop treatments. By means of ISP we can continue our work to discover new, effective and safe, treatment strategies for these complex disorders.