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.
Both IRL752 and IRL790, IRLAB’s two development compounds in Phase II studies were discovered by ISP. Over the last few years, IRLAB has filed two new patent applications on compounds developed using ISP, and we expect to nominate an additional development compound within our P001 research programme shortly. This illustrates the efficiency of ISP and our organization.
We are pleased that the planned UK Phase II study has rapidly received MHRA approval. There is a high interest among UK clinicians to participate in the study. We are looking forward to work with our UK colleagues and benefit from their extensive experience of clinical trials.
The approval from MHRA validates IRLABs technology by another independent competent authority. This supports the IRLAB capability to produce robust, international clinical drug candidates and projects.
It is highly pleasing that yet another Competent Authority, the Finnish MPA, has reviewed our candidate drug IRL752 and given their clinical trial approval. Now the study can recruit patients in both Sweden and Finland. In addition, we get to collaborate with highly skilled Finnish experts with vast experience of Parkinson’s disease.
The approval from the MPA and the ethics committee is very encouraging. The Phase II study with IRL752 is a double-blind placebo controlled study in patients with Parkinson’s disease and dementia. About 80 % of all patients suffering from Parkinson’s disease develops symptoms of dementia which, today, lack satisfactory treatment.
The results from Phase 1 and Phase 1b studies in patients with Parkinson’s disease and levodopa-induced dyskinesia in Sweden is promising for the continued development of IRL790. We have recently completed a feasibility analysis in the UK and found that UK clinics have a high clinical competence regarding Parkinson’s disease, a large patient base, and interest in conducting the Phase 2 study. We are looking forward to working with our colleagues at TCTC who have an extensive experience from conducting international clinical trials in neurodegenerative diseases.
TCTC is delighted to work with IRLAB on this study. There is a huge unmet medical need to improve the lives of patients with Parkinson’s disease and IRL790 is an exciting new potential treatment for patients with Parkinson’s disease dyskinesia. We are very much looking forward to working with the IRLAB team and the UK investigators to deliver this important study.