GOTHENBURG, SWEDEN / ACCESSWIRE / November 9, 2022 / IRLAB Therapeutics (STO:IRLAB-A)(FRA:6IRA) Gothenburg, Sweden, November 9, 2022 – IRLAB Therapeutics AB (Nasdaq Stockholm: IRLAB A), a biopharmaceutical in clinical-stage company that discovers and develops novel treatments for the most troublesome symptoms of Parkinson’s disease, announced today that the company’s interim report for the period January-September 2022 has been published.
SUMMARY OF THE THIRD QUARTER
IRLAB’s phase IIb study of mesdopetam (IRL790) in patients with Parkinson’s levodopa-induced dyskinesias (PD-LID) was expanded, as reported in July, to include 154 patients. In September, patient recruitment for the study was completed and top-line data is anticipated by the end of the year.
IRLAB partner Ipsen initiated clinical pharmacokinetic studies in September that are being conducted in parallel with the IRLAB-sponsored Phase IIb study of mesdopetam. The IPSEN-led clinical studies are expected to be completed between Q3 2022 and Q1 2023 and will provide a standard set of data typically required for late-stage drug development and preparation for potential additional studies with mesdopetam.
IRLAB has appeared at various investor events to provide a business update on the company’s progress, including at Pareto Securities, ABG Sundal Collier and ProHearings. Public recordings are available on the irlab.se website.
The issuance of 120,000 Class A shares corresponding to the acquisition of know-how related to the P003 discovery project was registered. After registration, the total number of registered shares is 51,868,406 (51,748,406).
THIRD QUARTER FINANCIAL HIGHLIGHTS
Recorded net sales: SEK 16.5 million (SEK 195.6 million)
Total operating expenses: SEK 40.4 million (SEK 74.1 million)
The operating result: SEK -23.9 million (SEK 121.7 million)
Cash flow from operations: SEK -27.9 million (SEK 202.8 million)
Cash and cash equivalents at the end of the period: SEK 291.7m (SEK 431.2m)
The total number of registered shares: 51,868,406 (51,748,406)
Figures in parentheses = same period 2021, unless otherwise indicated
PRESENTATION TO INVESTORS AND MEDIA
A presentation will take place on November 9, 2022 at 10:00 CET at Infront Direkt Studio, Kungsgatan 33, in Stockholm. CEO Richard Godfrey, Executive Vice President and R&D Director Nicholas Waters and CFO Viktor Siewertz will comment on the interim report for the period January-September 2022. The presentation will be delivered in English followed by a question and answer session. , and will be available upon request on our website.
It is also possible to follow the presentation online at: https://youtu.be/3gMDBBbrTW4
COMMENTS FROM THE EXECUTIVE DIRECTOR
During my first full quarter at IRLAB, we continued to make strong clinical progress in our core programs and now look forward to several major drug development milestones in the short and medium term. Building on our strong foundation, IRLAB’s portfolio of clinical, preclinical and research projects to address the substantial unmet medical needs in Parkinson’s disease is progressing as planned. Increasingly, this is attracting significant attention from the medical community and the pharmaceutical industry. Speaking with key opinion leaders, I find that many share my belief that IRLAB’s portfolio of drug candidates could indeed provide significant clinical benefit to people living with Parkinson’s.
Increased visibility and interest
An important aspect of our current focus is to increase our presence and visibility within the scientific, medical, pharmaceutical and investment communities. We have always been active, but we will increase our presence at conferences both financial and scientific, such as the Society for Neuroscience in San Diego in November and we have also committed to playing an active role in the International Conference on Alzheimer’s and Parkinson’s Disease, AD/ PS, in March 2023, which this time takes place in our hometown, Gothenburg, Sweden, where the organizers expect more than 4,700 participants. And with recent encouraging media coverage and our high presence in investment communities both in Sweden and internationally, we see an improvement in our profile that will support our business development and business strategies.
Main pending portfolio milestones
Focusing on the portfolio, our Phase IIb study with mesdopetam in people living with Parkinson’s and levodopa-induced dyskinesias (PD-LID) has completed patient recruitment. We now anticipate that the last patient in the study will complete their three-month treatment period in mid-December, after which the database will be locked and analyzed. Top-line results are anticipated around the turn of the year; this will be one of the company’s biggest development milestones to date. Together with our partner Ipsen, who has exclusive worldwide rights to continue the development and commercialization of mesdopetam, we are very excited to receive the results of the study. Preparations are underway in several different work streams to prepare for potential late-stage development and market readiness.
In conjunction with the release of this interim report, we will host a broadcast presentation discussing the Phase IIb study in more detail, including a review of the objectives, endpoints, and what we look for in the main results.
Pirepemat, our second Phase IIb candidate, is being developed to improve balance and reduce falls in people living with Parkinson’s. This is one of the greatest medical needs in Parkinson’s disease. We see that pirepemat has the potential to reduce the frequency of falls, resulting in fewer fall-related injuries, improving patient quality of life, reducing stress for caregivers, and reducing the economic burden on payers. The Phase IIb study is now recruiting late-stage Parkinson’s patients with mild cognitive impairment and increased frequency of falls. The objective of the study is to evaluate the dose-dependent efficacy of pirepemat in the evaluations of falls, cognitive and neuropsychiatric functions, in addition to continuing to build on the safety and tolerability data. This study is currently open at multiple sites in five European countries and patient recruitment is actively continuing. For now, we anticipate having the study fully recruited during the fall of 2023 and reporting the main results in late 2023.
Ongoing portfolio development
As we move our research projects into development-stage assets, we are evolving our portfolio and business into a substantial clinical-stage biopharmaceutical business. IRL757 and IRL942 are being developed to address Parkinson’s non-motor function symptoms, apathy and cognitive impairment, respectively, and potentially broader patient populations in neurology. Both actives show promising preclinical efficacy and safety profiles and are progressing according to the plan to start Phase I clinical trials in 2023. In addition, our research project P003 aims to develop an entirely new treatment for Parkinson’s, administered by orally once daily, without the bothersome complications of current standard of care or emerging treatments, is making encouraging progress toward DC nomination and regulated development toward clinical trials.
Strong quarter and bright outlook
This quarter has been very productive for IRLAB, making solid progress across all programs. Recognizing the challenging global economic and geopolitical situation, we believe IRLAB is well positioned and continue to evaluate options to further strengthen our position. Cash flow for the third quarter of 2022 was SEK -31 million; our balance sheet remains strong with a cash position of SEK 292 million at the end of the quarter. The next few months and indeed 2023 promise to be very exciting as we anticipate top-line data from our mesdopetam study very soon and we will also be in a position to provide updates on several other important clinical milestones. Thank you for your continued support as we continue to make solid progress in transforming treatment options for people living with Parkinson’s, and I look forward to speaking with you regularly as we move our drug candidates through clinical development.
Richard Godfrey, Managing Director, IRLAB
For more information, contact:
Richard Godfrey, CEO
Telephone: +46 730 70 69 00
Viktor Siewertz, CFO
Telephone: +46 727 10 70 70
IRLAB discovers and develops new treatments for Parkinson’s disease and other CNS disorders. The company’s most advanced drug candidates, mesdopetam (IRL790) and pirepemat (IRL752), are in Phase IIb and are designed to treat some of the most difficult symptoms associated with Parkinson’s. In 2021, Ipsen, a specialty pharmaceutical company, acquired the exclusive global rights to develop and commercialize mesdopetam.
IRLAB has discovered and generated all of its drug candidates and continues to discover innovative drug candidates for the treatment of CNS disorders through its proprietary systems biology-based Integrative Screening Process (ISP) research platform. In addition to IRLAB’s strong pipeline of clinical projects, the company is also advancing two preclinical programs, IRL942 and IRL757, towards Phase I studies. IRLAB is listed on Nasdaq Stockholm. More information about irlab.se.
FONT: IRLAB Therapeutics
See the source version at accesswire.com: