Immunic Highlights 2024 Accomplishments and Upcoming Milestones
Immunic (NASDAQ: IMUX) highlighted its 2024 achievements and upcoming milestones for its lead drug candidate vidofludimus calcium. The company expects top-line data from Phase 2 CALLIPER trial in progressive multiple sclerosis in April, while its twin Phase 3 ENSURE trials in relapsing multiple sclerosis are progressing as planned for completion in 2026.
The company secured a three-tranche private placement totaling up to $240 million, with an initial tranche of $80 million completed in January 2024, extending cash runway into Q3 2025. The Phase 3 ENSURE program received positive interim analysis results, with the Independent Data Monitoring Committee recommending continuation without changes.
Additionally, Immunic strengthened its management team with key appointments and published positive results from the Phase 1/1b trial of IMU-856 in The Lancet Gastroenterology & Hepatology, showing promising effects in celiac disease patients.
Immunic (NASDAQ: IMUX) ha evidenziato i risultati raggiunti nel 2024 e i prossimi obiettivi per il suo principale candidato farmaco, il vidofludimus calcio. L'azienda prevede di ottenere dati preliminari dal trial di Fase 2 CALLIPER sulla sclerosi multipla progressiva ad aprile, mentre i trial gemelli di Fase 3 ENSURE sulla sclerosi multipla recidivante stanno procedendo come previsto per il completamento nel 2026.
La società ha garantito un collocamento privato a tre tranche per un totale massimo di 240 milioni di dollari, con una prima tranche di 80 milioni di dollari completata a gennaio 2024, estendendo la disponibilità di liquidità fino al terzo trimestre del 2025. Il programma di Fase 3 ENSURE ha ricevuto risultati positivi dall'analisi intermedia, con il Comitato Indipendente di Monitoraggio dei Dati che ha raccomandato di proseguire senza modifiche.
Inoltre, Immunic ha rafforzato il proprio team di gestione con nomine chiave e ha pubblicato risultati positivi dal trial di Fase 1/1b di IMU-856 su The Lancet Gastroenterology & Hepatology, mostrando effetti promettenti sui pazienti con celiachia.
Immunic (NASDAQ: IMUX) destacó sus logros de 2024 y los próximos hitos para su candidato principal de medicamento, el vidofludimus calcio. La compañía espera datar datos preliminares del ensayo de Fase 2 CALLIPER en esclerosis múltiple progresiva en abril, mientras que sus ensayos gemelos de Fase 3 ENSURE en esclerosis múltiple recurrente están avanzando según lo planeado para su finalización en 2026.
La empresa aseguró un colocación privada de tres tramos que suma hasta $240 millones, con un primer tramo de $80 millones completado en enero de 2024, extendiendo así su disponibilidad de efectivo hasta el tercer trimestre de 2025. El programa de Fase 3 ENSURE recibió resultados positivos de un análisis intermedio, con el Comité Independiente de Monitoreo de Datos recomendando continuar sin cambios.
Además, Immunic fortaleció su equipo de gestión con nombramientos clave y publicó resultados positivos del ensayo de Fase 1/1b de IMU-856 en The Lancet Gastroenterology & Hepatology, mostrando efectos prometedores en pacientes con enfermedad celíaca.
이뮤닉 (NASDAQ: IMUX)은 2024년 성과와 주요 약물 후보인 비도플루디무스 칼슘의 향후 이정표를 강조했습니다. 이 회사는 4월에 진행성 다발성 경화증에 대한 2상 CALLIPER 시험의 초기 데이터를 기대하고 있으며, 재발형 다발성 경화증에 대한 쌍둥이 3상 ENSURE 시험이 2026년 완료를 목표로 계획대로 진행되고 있습니다.
회사는 최대 2억 4천만 달러 규모의 3단계 민간 배치를 확보했으며, 2024년 1월에 8천만 달러 규모의 초기 단계가 완료되어 2025년 3분기까지 현금 유동성을 연장했습니다. 3상 ENSURE 프로그램은 긍정적인 중간 분석 결과를 받았으며, 독립 데이터 모니터링 위원회는 수정 없이 계속 진행할 것을 권장했습니다.
또한, 이뮤닉은 주요 임명으로 관리 팀을 강화했고, The Lancet Gastroenterology & Hepatology에 IMU-856의 1상/1b 시험에서 양호한 결과를 발표하여 셀리악병 환자들에게 유망한 효과를 보였습니다.
Immunic (NASDAQ: IMUX) a mis en avant ses réalisations de 2024 et ses prochaines étapes concernant son principal candidat médicamenteux, le vidofludimus calcium. La société attend des données préliminaires de l'essai de Phase 2 CALLIPER sur la sclérose en plaques progressive en avril, tandis que ses essais jumelés de Phase 3 ENSURE sur la sclérose en plaques récurrente avancent comme prévu pour une finalisation en 2026.
L'entreprise a sécurisé un placement privé en trois tranches d'un total pouvant atteindre 240 millions de dollars, la première tranche de 80 millions de dollars ayant été complétée en janvier 2024, prolongeant ainsi sa liquidité jusqu'au troisième trimestre 2025. Le programme ENSURE en Phase 3 a reçu des résultats d'analyse intermédiaire positifs, le comité indépendant de surveillance des données recommandant de poursuivre sans changements.
De plus, Immunic a renforcé son équipe de direction avec des nominations clés et a publié des résultats positifs de l'essai de Phase 1/1b de l'IMU-856 dans The Lancet Gastroenterology & Hepatology, montrant des effets prometteurs chez les patients atteints de maladie coeliaque.
Immunic (NASDAQ: IMUX) hob die Erfolge von 2024 sowie anstehende Meilensteine für seinen Hauptkandidaten Vidofludimus Calcium hervor. Das Unternehmen erwartet erste Daten aus der Phase-2-Studie CALLIPER zur fortschreitenden Multiplen Sklerose im April, während die beiden Phase-3-ENSURE-Studien zur rückfallenden Multiplen Sklerose planmäßig bis 2026 abgeschlossen werden.
Das Unternehmen sicherte sich eine drei Tranchen umfassende Privatplatzierung in Höhe von insgesamt bis zu 240 Millionen USD, wobei die erste Tranche über 80 Millionen USD im Januar 2024 abgeschlossen wurde, was die Liquidität bis ins dritte Quartal 2025 verlängert. Das Phase-3-ENSURE-Programm erhielt positive Ergebnisse aus der interims Analyse, wobei das unabhängige Datenüberwachungskomitee die Fortsetzung ohne Änderungen empfahl.
Darüber hinaus stärkte Immunic sein Management-Team mit wichtigen Ernennungen und veröffentlichte positive Ergebnisse aus der Phase-1/1b-Studie von IMU-856 in The Lancet Gastroenterology & Hepatology, die vielversprechende Wirkungen bei Zöliakie-Patienten aufzeigte.
- Secured up to $240 million private placement with initial $80 million tranche completed
- Positive interim analysis results for Phase 3 ENSURE trials, continuing without sample size increase
- Cash runway extended into Q3 2025
- Published positive Phase 1/1b results for IMU-856 in prestigious medical journal
- Phase 3 ENSURE trials completion not expected until 2026
- Future development of IMU-856 contingent on additional financing or partnerships
Insights
The
The April CALLIPER trial readout represents a major catalyst, potentially opening up the progressive MS market. Current progressive MS treatments generate billions in annual revenue, making this an attractive commercial opportunity. The positive interim NfL biomarker data suggests promising neuroprotective effects, which could differentiate vidofludimus calcium in the competitive MS landscape.
The positive IDMC review of the phase 3 ENSURE trials reduces development risk and validates trial design. With completion expected in 2026, IMUX is positioned for potential commercialization in the larger relapsing MS market, estimated at over
The dual mechanism of vidofludimus calcium - Nurr1 activation for neuroprotection combined with selective DHODH inhibition for anti-inflammatory effects - presents a unique value proposition in MS treatment. This approach could address both the inflammatory and neurodegenerative aspects of MS, a significant unmet need in current therapeutics.
The reduction in neurofilament light chain (NfL) levels observed in the CALLIPER interim analysis is particularly noteworthy, as NfL is an established biomarker for neuronal damage. This early signal of neuroprotection could translate into meaningful clinical outcomes for progressive MS patients, where current treatment options are
The extended patent protection until 2041 for the specific polymorph composition provides strong intellectual property protection, important for maintaining market exclusivity and commercial value.
– Top-Line Data from Phase 2 CALLIPER Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis Expected in April –
– Reported Positive Outcome from Interim Analysis of Ongoing, Twin Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis; Both Trials on Track to Be Completed in 2026 –
– Strengthened Management Team and Board of Directors with Key Hires –
– Announced a Three-Tranche Private Placement Totaling Up to
"The past year was marked by substantial progress for our orally available lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), as we continued to advance both our phase 2 CALLIPER trial in patients with progressive multiple sclerosis (PMS) and our twin phase 3 ENSURE trials in relapsing multiple sclerosis (RMS)," stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "Looking ahead, we eagerly anticipate reporting top-line data from the CALLIPER trial in April. The previously reported interim results showed a clear reduction versus placebo in neurofilament light chain (NfL) levels across the PMS patient population, hinting to potential neuroprotective effects of the drug."
"We also achieved a significant milestone for our phase 3 ENSURE program, having received a positive interim result from an unblinded Independent Data Monitoring Committee (IDMC), which concluded that the trials are not futile and recommended they should continue as planned, without any sample size increase. These favorable recommendations corroborated our initial assumptions about the design, powering and relapse rate of the trials and illustrate that they remain on track. The result makes us immensely confident and excited as we await the completion of the twin phase 3 trials: ENSURE-1 remains on track for completion in the second quarter of 2026, with ENSURE-2 expected to follow in the second half of 2026."
Jason Tardio, President and Chief Operating Officer of Immunic, added, "Since joining Immunic in July 2024, we have ramped up our efforts preparing for the potential commercial launch of vidofludimus calcium. There continues to be a large unmet medical need for new therapeutic advancements in the treatment of MS that address both the neuroinflammatory and neurodegenerative aspects of the disease to better slow disability worsening. Vidofludimus calcium is the only medicine in development that targets activation of Nurr1 for neuroprotection and combines that with selective inhibition of DHODH for anti-inflammatory and antiviral effects. We believe our drug has the potential to become the first oral disease-modifying therapy approved to treat both relapsing and progressive MS to address the full spectrum of the disease."
Dr. Vitt concluded, "In 2024, we were also honored to have had our previously reported results from the phase 1/1b clinical trial of IMU-856, our orally available and systemically acting small molecule modulator targeting Sirtuin 6 (SIRT6), a protein which serves as a transcriptional regulator of intestinal barrier function and physiological regeneration of bowel epithelium, published in the peer reviewed journal, The Lancet Gastroenterology & Hepatology. Data from this study showed that, in patients with celiac disease during periods of gluten-free diet and gluten challenge, IMU-856 demonstrated positive effects over placebo in four key dimensions of celiac disease, including protection of the gut architecture, improvement of patients' symptoms, biomarker response, and enhancement of nutrient absorption. We continue to believe that IMU-856 could offer a new therapeutic approach for various gastrointestinal disorders, also beyond celiac disease."
2024 Corporate Highlights
- Strengthened the Board of Directors in July, with the appointment of Simona Skerjanec, M.Pharm, MBA, a thought-leader in brain health with decades of experience.
- In July, appointed seasoned biopharmaceutical executive, Jason Tardio, as President and Chief Operating Officer, to lead internal efforts in positioning the company for the potential launch of vidofludimus calcium and to work closely with Patrick Walsh, Chief Business Officer, to prepare the company for a range of potential partnership outcomes. Additionally, reported that Werner Gladdines, former Vice President, Program Management & Clinical Development Operations, was promoted to Chief Development Officer.
- Announced a three-tranche private placement totaling up to
$240 million $80 million
Vidofludimus Calcium 2024 Highlights and Upcoming Milestones
- Completion of the ENSURE-1 trial of vidofludimus calcium in RMS is anticipated in the second quarter of 2026, with completion of ENSURE-2 expected in the second half of 2026.
- Top-line data for the phase 2 CALLIPER trial of vidofludimus calcium in PMS is expected in April of this year.
- Announced a positive outcome of the interim analysis of the phase 3 ENSURE program, investigating vidofludimus calcium for the treatment of RMS, in October. An unblinded IDMC confirmed that the trials are not futile and recommended they should continue without changes, including no need for a potential increase of the sample size.
- Presented key data on vidofludimus calcium in four presentations at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in September. The data included the NfL interim data from the phase 2 CALLIPER trial, antiviral data suggesting an effect on reducing fatigue, Nurr1 target data supporting a neuroprotective profile, and pathogenic T cell data further supporting the drug's anti-inflammatory effects.
- Announced enrollment of the first patient in the investigator-sponsored phase 2 RAPID_REVIVE trial of vidofludimus calcium in patients with post COVID syndrome in September.
- Hosted an MS R&D Day in
New York City in September, focused on vidofludimus calcium's potential to become the treatment of choice for both RMS and PMS patients. Presenting MS industry experts included Francesca Montarolo, Ph.D., Neuroscience Institute Cavalieri Ottolenghi (NICO) and University ofTurin, Italy and Amit Bar-Or, M.D., FRCPC, Department of Neurology, Perelman School of Medicine, University ofPennsylvania . - Published extended data from the phase 2 EMPhASIS trial of vidofludimus calcium in relapsing-remitting MS in the peer reviewed journal, Neurology® Neuroimmunology & Neuroinflammation, an official journal of the American Academy of Neurology, in April.
- Hosted an MS R&D Day in
San Francisco in April, during which management discussed the latest developments in the MS landscape, along with recent preclinical and clinical data supporting the neuroprotective potential of vidofludimus calcium. - Received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) in March, for a patent covering the composition-of-matter of a specific polymorph of vidofludimus calcium and a related method of production of the material. The company's multilayered intellectual property strategy now provides protection into 2041 in
the United States , unless extended further. - Presented data from the company's phase 2 CALLIPER and CALVID-1 trials of vidofludimus calcium, in two poster presentations at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2024 in February.
IMU-856 2024 Highlights and Upcoming Milestones
- Announced the publication of data from the phase 1/1b clinical trial of IMU-856 in the peer reviewed journal, The Lancet Gastroenterology & Hepatology in November.
- Based on the positive data from the phase 1b clinical trial, the company continues preparing for clinical phase 2 testing of IMU-856, contingent on financing, licensing or partnering.
Immunic's management, business development and investor relations teams will be hosting one-on-one meetings in connection with the 43rd Annual J.P. Morgan Healthcare Conference taking place January 13-16, 2025, in
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 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 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; expectations regarding the capitalization, resources and ownership structure of the company; the executive and board structure 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
Contact Information
Immunic, Inc.
Jessica Breu
Vice President Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.com
US IR Contact
Rx Communications Group
Paula Schwartz
+1 917 633 7790
immunic@rxir.com
US Media Contact
KCSA Strategic Communications
Caitlin Kasunich
+1 212 896 1241
ckasunich@kcsa.com
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SOURCE Immunic, Inc.
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