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IMUX $1.83 + 16% Immunic Announces Positive Outcome of Interim Analysis of Phase 3 ENSURE Program of Vidofludimus Calcium in Relapsing Multiple Sclerosis
Source: PR Newswire (US)
– Based on a Review of Unblinded Data, an Independent Data Monitoring Committee (IDMC) Confirmed that Predetermined Futility Criteria Have Not Been Met –
– IDMC Also Recommended Continuing Trial without Changes, Including no Need for a
Potential Upsizing –
– ENSURE Program Remains on Track to be Completed in 2026 –
– Webcast to be Held Today, October 22, at 8:00 am ET –
NEW YORK, Oct. 22, 2024 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced a positive outcome of the non-binding, interim futility analysis of its phase 3 ENSURE program, investigating lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), for the treatment of relapsing multiple sclerosis (RMS). Based on the outcome of the interim futility analysis, an unblinded Independent Data Monitoring Committee (IDMC) has recommended that the trials are not futile and should continue as planned.
"While Immunic remains blinded to all data, the IDMC's favorable recommendations in this interim analysis corroborate our initial assumptions for the design, powering and relapse rate of the twin phase 3 trials of vidofludimus calcium in RMS, and suggest that they are in line with the data observed so far," stated Andreas Muehler, M.D., M.B.A., Chief Medical Officer of Immunic. "In particular, the planned sample size seems appropriate to address the primary endpoint of time to first relapse. As the IDMC recommends, we are continuing the ENSURE trials unchanged, with completion expected in 2026."
"I am particularly excited about the positive outcome of the interim analysis of our phase 3 ENSURE trials, marking the successful achievement of a critical milestone for the program," added Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "We are confident in vidofludimus calcium's potential to transform the oral MS market and continue to believe that the phase 3 program provides a clear and straightforward path towards seeking potential regulatory approval in RMS. Our next clinical milestone for vidofludimus calcium is the top-line readout of our phase 2 CALLIPER trial in patients with progressive multiple sclerosis (PMS), which we expect to release in April of next year. If this data set continues to show a neuroprotective effect for vidofludimus calcium, we believe our drug may be positioned as first-in-class oral treatment option for PMS, a form of MS with highest unmet medical needs."
The interim futility analysis of the phase 3 ENSURE program was performed by an unblinded IDMC and based on a pre-specified assessment after approximately half of the planned first relapse events occurred in the double-blind treatment periods of each of the twin ENSURE-1 and ENSURE-2 trials. The analysis was intended to inform potential sample size adjustment and help prevent the final study readout from occurring before sufficient events have been achieved. The unblinded IDMC was asked to make two decisions: The first question, as to whether the trials are futile, was answered by the IDMC with "futility criteria have not been met." The second question, as to whether the sample size in each trial should be increased, was answered by the IDMC with "continue as planned." Both decisions were based on the conditional power of the trials at the time of the interim analysis. Immunic has remained blinded during the interim analysis and has not seen any of the data available to the IDMC to make their recommendations.
The ongoing ENSURE program comprises two identical multicenter, randomized, double-blind phase 3 trials designed to evaluate the efficacy, safety and tolerability of vidofludimus calcium versus placebo in RMS patients. Each of the trials, titled ENSURE-1 and ENSURE-2, is expected to enroll approximately 1,050 adult patients with active RMS at more than 100 sites in more than 15 countries, including the United States, India and countries in Latin America, Central and Eastern Europe. Patients are being randomized in a double-blinded fashion to either 30 mg daily doses of vidofludimus calcium or placebo and the primary endpoint for both trials is time to first relapse up to 72 weeks. Key secondary endpoints include time to confirmed disability worsening based on Expanded Disability Status Scale (EDSS) disability progression, volume of new T2-lesions, time to sustained clinically relevant changes in cognition, and percentage of whole brain volume change, grey matter volume and white matter volume. As previously reported, completion of ENSURE-1 is anticipated in the second quarter of 2026, with completion of ENSURE-2 expected in the second half of 2026.
Webcast Information
Immunic will host a webcast today at 8:00 am ET. To participate in the webcast, please register in advance at: https://imux.zoom.us/webinar/register/WN_fSJNHWuxRMGRPaMl3hUlqg or on the "Events and Presentations" section of Immunic's website at: ir.imux.com/events-and-presentations. Registrants will receive a confirmation email containing a link for online participation or a telephone number for dial-in access.
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10 months ago
NEWS
Immunic Highlights 2023 Accomplishments and Upcoming Milestones
– Evidence for Neuroprotective Activity of Vidofludimus Calcium from Phase 2 CALLIPER Interim Analysis, Consistent Across the Entire Progressive Multiple Sclerosis Population and All Subtypes –
– Phase 3 ENSURE Program in Relapsing Multiple Sclerosis Ongoing –
– Improvements in Gut Health Demonstrated in Phase 1b Clinical Trial of IMU-856 in Celiac Disease –
– Expanded Vidofludimus Calcium Patent Portfolio with Additional New Patents Granted; Exclusivity Protection Expected Into 2041 in the United States, Unless Extended Further –
– Significantly Strengthened Balance Sheet; Cash Runway Extended Into the Third Quarter of 2025 Based on First Tranch of January 2024 Financing –
NEW YORK, Jan. 5, 2024 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today highlighted its 2023 accomplishments and upcoming milestones.
"The past year has been an extra-ordinarily productive and successful one for Immunic, with key clinical data releases highlighting the uniqueness and enormous value potential of each of our two latest-stage clinical assets," stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "With vidofludimus calcium (IMU-838) and IMU-856, we have two development programs beyond clinical proof-of-concept which is an outstanding achievement of our entire team. Regarding our lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium, the interim biomarker analysis from the phase 2 CALLIPER trial demonstrated clear separation from placebo in serum neurofilament light chain (NfL) levels in patients with progressive multiple sclerosis (PMS). This effect was observed across all subpopulations, including non-active secondary progressive multiple sclerosis, which we believe represents the segment of greatest unmet need in multiple sclerosis (MS). We look forward to continuing development of this potentially groundbreaking asset. Enrollment in CALLIPER is complete, with top-line data expected in April 2025. Meanwhile, enrollment in our phase 3 ENSURE program remains active, with an interim futility analysis expected in late 2024 and the read-out of the first of the ENSURE trials anticipated in the second quarter of 2026."
Dr. Vitt continued, "Regarding IMU-856, our orally available and systemically acting small molecule modulator targeting Sirtuin 6 (SIRT6), results from our phase 1b trial demonstrated meaningful improvements over placebo in four key dimensions of celiac disease pathophysiology: histology, disease symptoms, biomarkers and nutrient absorption. We believe this data provides initial clinical proof-of-concept for a potentially new therapeutic approach to a multitude of gastrointestinal disorders through the regeneration of bowel architecture rather than the traditional immunomodulatory approaches in many gastrointestinal indications. We are currently preparing for phase 2 testing in ongoing active celiac disease (OACD), with further clinical applications in other gastrointestinal disorders also being considered."
"On a scientific level, we announced preclinical evidence showing that vidofludimus calcium acts as a potent Nurr1 activator, which may be associated with both its hypothesized neuroprotective effects and the reduced disability-worsening events observed in our phase 2 EMPhASIS trial in relapsing-remitting MS patients. We have also continued to strengthen our patent portfolio for vidofludimus and its salt and free acid forms, with additional new layers of patents granted, now providing protection into 2041 in the United States and into 2038 internationally. We expect to continue to expand the patent protection around vidofludimus calcium in the future," Dr. Vitt continued.
"Financially, we announced a three-tranche private placement of up to $240 million earlier today. We expect the first $80 million tranche to extend our cash runway into the third quarter of 2025, which well covers the top-line data readout of our CALLIPER trial in Aprill 2025. The second tranche, assuming it is excersied, would even finance us into the first quarter of 2027. Despite challenging capital markets, we are proud to see enormous support from new and existing investors, including lead investor BVF Partners, as well as Avidity Partners, Janus Henderson Investors, Soleus Capital, RTW Investments and Adage Capital Partners. Finally, I want to share my pride in our broader team, who were honored to win multiple, prestigious international awards in 2023 recognizing Immunic's excellence in a number of clinical, corporate and communications categories. I am very excited to see what our team can achieve in 2024 and beyond," concluded Dr. Vitt.
A more thorough review of recent events and upcoming milestones follows:
Corporate Highlights
Announced a three-tranche private placement of up to $240 million with participation from select new and existing investors today.
Strengthened Board of Directors in April 2023 with the addition of Richard Rudick, M.D., a thought-leader in MS with decades of experience in the clinic, academia and industry.
Vidofludimus Calcium 2023 Highlights and Upcoming Milestones
Reported positive interim data from the phase 2 CALLIPER trial of vidofludimus calcium in PMS in October. Serum NfL improvements were consistently observed for vidofludimus calcium across PMS and all disease subtypes, as well as in patients who showed or did not show disease and/or magnetic resonance imaging (MRI) activity. Immunic believes that this data illustrates biomarker evidence that vidofludimus calcium's activity extends beyond the previously observed anti-inflammatory effects, further reinforcing its neuroprotective potential. Enrollment of the trial was completed in August. In total, 467 patients with primary PMS, or active or non-active secondary PMS, were randomized to either 45 mg of vidofludimus calcium or placebo.
Published preclinical data in the peer-reviewed, high impact, Journal of Medicinal Chemistry in May, confirming that vidofludimus calcium acts as a potent Nurr1 activator, in addition to its known mode of action as a dihydroorotate dehydrogenase (DHODH) inhibitor. Data showed that activation of Nurr1 could be responsible for the drug's postulated neuroprotective effects and may contribute to the previously reported reduction of confirmed disability worsening events seen in the phase 2 EMPhASIS trial in relapsing-remitting MS patients.
Reported positive data from the maintenance phase of the phase 2b CALDOSE-1 trial of vidofludimus calcium in patients with moderate-to-severe ulcerative colitis in April.
Significantly strengthened the multiple layers of patent protection around vidofludimus calcium, and other salt and free acid forms, with the receipt of two Notices of Allowance from the USPTO, covering the dosing regimens in MS and the dose strength for the treatment of RMS. The current patent portfolio provides protection into 2041 in the United States and into 2038 internationally, unless extended further.
Top-line data from the phase 2 CALLIPER trial of vidofludimus calcium in PMS is expected in April 2025.
An interim futility analysis of the ENSURE program is expected in late 2024. The read-out of the first of the ENSURE trials is currently anticipated in the second quarter of 2026; and the second ENSURE trial in the second half of 2026.
IMU-856 2023 Highlights and Upcoming Milestones
Announced, for the first time, IMU-856's molecular mode of action as a highly selective and potent small molecule modulator of SIRT6, a protein which serves as a transcriptional regulator of intestinal barrier function and regeneration of bowel epithelium, in May.
Announced positive results from the part C portion of the phase 1 clinical trial of IMU-856 in patients with celiac disease in May. The data demonstrated positive effects for IMU-856 over placebo in four key dimensions of celiac disease pathophysiology: protection of the gut architecture, improvement of patients' symptoms, biomarker response and enhancement of nutrient absorption. IMU-856 was also observed to be safe and well-tolerated in this trial. Immunic believes this data provides initial clinical proof-of-concept for an entirely new therapeutic approach to gastrointestinal disorders by promoting regeneration of bowel architecture.
The company is preparing for clinical phase 2 testing of IMU-856 in OACD patients.
Award Recognition
MS R&D webcast held in November 2022:Gold German Stevie Awards for 'Best Medical Event' and 'Best B2B Event'American Business Gold Awards in the 'Conferences & Meetings – Medical Congress' and 'Conferences & Meetings – Scientific Congress' categories and Bronze Award in the 'Corporate & Community – B2B Event' categoryInternational Business Gold Award in the 'Conferences & Meetings - Medical Congress' category
Newly designed, accessibility-friendly website:Gold German Stevie Award for 'Best Overall Design' and Bronze Stevie Award for 'Special Achievement in Diversity & Inclusion'American Business Silver Award in the 'Achievement in Diversity & Inclusion' category
BioTech Breakthrough Award winner for the 'Developmental Immunology Solution of the Year' for the IMU-856 development program, including the positive phase 1b clinical trial results in celiac disease
Hella Kohlhof, Ph.D., Chief Scientific Officer of Immunic, was awarded a Silver Stevie Award for Women in Business in the 'Women in Healthcare' category
Immunic's management, business development and investor relations teams will be hosting one-on-one meetings in connection with the 42nd Annual J.P. Morgan Health Care Conference taking place January 8-11, 2024 in San Francisco. To schedule a meeting, please contact: Jessica Breu at jessica.breu@imux.com.
About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 and phase 2 clinical trials for the treatment of relapsing and progressive multiple sclerosis, respectively, and has shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis, progressive multiple sclerosis and moderate-to-severe ulcerative colitis. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease, for which it is currently in preparations for a phase 2 clinical trial. IMU-381, which currently is in preclinical testing, is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases. For further information, please visit: www.imux.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding expected future events, including the private placement and expected proceeds, strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's ability to raise additional capital, if needed; Immunic's development programs and the targeted diseases; the potential for Immunic's development programs to safely and effectively target diseases; preclinical and clinical data for Immunic's development programs; the timing of current and future clinical trials and anticipated clinical milestones; the nature, strategy and focus of the company and further updates with respect thereto; the development and commercial potential of any product candidates of the company; and the company's expected cash runway. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the COVID-19 pandemic, increasing inflation, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves
subslover
2 years ago
Immunic Reports New Data From Phase 2 EMPhASIS Trial of Vidofludimus Calcium in Relapsing-Remitting Multiple Sclerosis Supporting the Drug's Neuroprotective Potential
November 17 2022 - 06:30AM
PR Newswire (US)
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– Data Show Encouraging Signals for Vidofludimus Calcium for Preventing or Delaying Confirmed Disability Worsening –
– Virtual Multiple Sclerosis R&D Day to be Held Today, November 17, 2022 at 11:00 am ET –
NEW YORK, Nov. 17, 2022 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases, today reported newly available data from its phase 2 EMPhASIS trial of lead asset, vidofludimus calcium (IMU-838), in relapsing-remitting multiple sclerosis (RRMS). Long-term open-label treatment with vidofludimus calcium was associated with a low rate of confirmed disability worsening over time, and compares favorably to historical trial data for currently available multiple sclerosis (MS) medications.
EMPhASIS is an international, multicenter, double-blind, placebo-controlled, randomized, parallel-group trial, designed to assess the efficacy and safety of vidofludimus calcium in patients with RRMS. The trial included a 24-week blinded main treatment period testing 10, 30 and 45 mg of vidofludimus calcium and placebo. In the third quarter of 2020, Immunic reported that the trial achieved both primary and key secondary endpoints with high statistical significance, with a safety and tolerability profile similar to placebo.
The trial also includes an optional long-term open-label extension (OLE) phase running up to 9.5 years. An interim analysis was performed with data extraction in October 2022, when 209 patients remained on treatment in the OLE phase, some of whom have already received more than 180 continuous weeks (approximately four years) of active treatment with vidofludimus calcium.
During the 24-week double-blind main treatment period, 12-week and 24-week Confirmed Disability Worsening (12w/24wCDW) events occurred in 1.6% of subjects in the combined vidofludimus calcium treatment arms as compared to 3.7% in the placebo group. In the OLE phase, the proportion of patients free from 12wCDW was 97.6% after 48 weeks and 94.5% after 96 weeks of vidofludimus calcium treatment as compared to the start of the OLE phase. Similar results were observed for 24wCDW and sustained CDW. The OLE phase also showed low relapse activity.
"The newly obtained data from our phase 2 EMPhASIS trial of vidofludimus calcium in RRMS patients demonstrate an encouraging signal in preventing 12-week and 24-week confirmed disability worsening events as compared to placebo during the double-blind treatment phase. In addition, only a few patients on continuous open-label treatment with vidofludimus calcium developed confirmed disability worsening events over a 2-year time frame, and those rates observed with vidofludimus calcium are on the lower end of those observed in historical trials with currently approved MS medications," stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "We look forward to receiving further, confirmatory data from our phase 3 ENSURE program in relapsing MS as well as our phase 2 CALLIPER trial in progressive MS. Our next MS-related data inflection point is an interim analysis for CALLIPER at the end of 2023 which will provide selected biomarker and functional data to guide study progress. If approved, we believe that vidofludimus calcium has the potential to be a unique treatment option targeted to the biology of MS with combined anti-inflammatory, antiviral, and neuroprotective effects."
Multiple Sclerosis R&D Webcast
Immunic will host a Multiple Sclerosis R&D Webcast today, November 17, 2022 at 11:00 am ET. During the event, Immunic will provide an update on the scientific, preclinical and clinical progress of vidofludimus calcium in MS. In addition to the above-mentioned new data from the EMPhASIS trial, the presentation will include an update the ongoing phase 3 ENSURE program in relapsing MS and the ongoing phase 2 CALLIPER trial in progressive MS, as well as the drug's potential strategic and commercial positioning in the MS landscape.
Moreover, three invited key opinion leaders will discuss recent scientific findings and their effect on the MS treatment landscape. The featured experts will be:
Fred D. Lublin, M.D., Saunders Family Professor of Neurology, Director, The Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Icahn School of Medicine, Mount Sinai Hospital, New York, NY, USA
Dr. Lublin will discuss new data published in 2022 illustrating that relapse-independent worsening is responsible for approximately 50% of disability worsening in the relapsing phase of MS, and 100% in the progressive phase of MS (Lublin FD, et al. How patients with multiple sclerosis acquire disability. Brain. 2022 Sep 14;145(9):3147-3161).
Lawrence Steinman, M.D., Professor of Neurology and Neurological Sciences, Pediatrics, and Genetics, Stanford University School of Medicine, Department of Neurology & Neurological Sciences, Stanford, CA, USA
Dr. Steinman will present new data published in 2022 confirming the presence of cross-reactive antibodies between the Epstein-Barr virus (EBV) antigen EBNA1 and the central nervous system (CNS) protein GlialCAM found in the cerebrospinal fluid of MS patients (Robinson WH, Steinman L. Epstein-Barr virus and multiple sclerosis. Science. 2022 Jan 21;375(6578):264-265).
Heinz Wiendl, M.D., Ph.D., Director Department of Neurology with Institute of Translational Neurology, University of Mu¨nster, Mu¨nster, Germany
Dr. Wiendl will elaborate on new data published in 2022 showing that T cells in MS patients continuously recognize known EBV antigens not seen in a control group, consistent with an ongoing anti-EBV immune reaction in MS patients (Schneider-Hohendorf T, et al. Broader Epstein-Barr virus-specific T cell receptor repertoire in patients with multiple sclerosis. J Exp Med. 2022 Nov 7;219(11):e20220650).
Speakers from Immunic will be:
Daniel Vitt, Ph.D., Chief Executive Officer and President
Andreas Muehler, M.D., M.B.A., Chief Medical Officer
Hella Kohlhof, Ph.D., Chief Scientific Officer
"We look forward to discussing the preclinical and clinical development progress of vidofludimus calcium at our MS R&D Day and would like to extend our thanks to Dr. Fred Lublin, Dr. Larry Steinman and Dr. Heinz Wiendl for joining the event," said Andreas Muehler, M.D., Chief Medical Officer of Immunic. "We are very excited that these three experts, the main authors of three major publications changing our pathophysiological understanding of MS, are part of this R&D Day. Dr. Lublin's analysis showed that there is a major component of disability worsening, even in early MS disease, that is independent of relapse and supports the notion that a smoldering, slowly progressing disease is an essential part of this disease. The publications by Dr. Steinman and Dr. Wiendl provide strong new evidence that EBV and related immune reactions may play a role during the course of the disease and may be hypothesized to contribute to a smoldering chronic infection. We believe that vidofludimus calcium, with its signal in preventing or delaying confirmed disability worsening seen in our phase 2 EMPhASIS trial and its well documented antiviral activity, including on EBV, is well positioned to address the newly highlighted mechanisms of disease progression."
Webcast Information
The MS R&D webcast will be held virtually via Zoom. To participate, please register in advance at: https://imux.zoom.us/webinar/register/WN_vVIraQmQTpG2dmAb8c9Qng.
Registrants will receive a confirmation email containing a link for online participation or a telephone number for dial in access.
An archived replay of the webcast will be available approximately one hour after completion on the "Events and Presentations" section of Immunic's website at: ir.imux.com/events-and-presentations.
About Vidofludimus Calcium (IMU-838)
Vidofludimus calcium is an investigational drug in development as an orally available, next-generation selective immune modulator that is designed to inhibit the intracellular metabolism of activated immune cells by blocking the enzyme dihydroorotate dehydrogenase (DHODH). Vidofludimus calcium has been observed in preclinical studies to act on activated T and B cells while leaving other immune cells largely unaffected and allows the immune system to stay functioning, e.g., in fighting infections. In previous trials, vidofludimus calcium did not show an increased rate of infections compared to placebo. In addition, DHODH inhibitors, such as vidofludimus calcium, are known to possess a host-based antiviral effect, which is independent with respect to specific virus proteins and their structure. Therefore, DHODH inhibition may be broadly applicable against multiple viruses. To date, vidofludimus calcium has been tested in more than 1,100 individuals and has shown an attractive pharmacokinetic, safety and tolerability profile. Vidofludimus calcium is not yet licensed or approved in any country.
About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a clinical-stage biopharmaceutical company with a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases. The company is developing three small molecule products: its lead development program, vidofludimus calcium (IM
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