NEW YORK - Immunic, Inc. (NASDAQ: NASDAQ:IMUX), a biotechnology firm focused on treatments for chronic inflammatory and autoimmune diseases, announced today that its phase 3 ENSURE program for the drug vidofludimus calcium (IMU-838) will continue without modifications based on recommendations from an Independent Data Monitoring Committee (IDMC). The IDMC's interim analysis determined that the trials for the treatment of relapsing multiple sclerosis (RMS) have not met futility criteria.
The ENSURE program, which consists of two identical phase 3 trials named ENSURE-1 and ENSURE-2, is evaluating the efficacy, safety, and tolerability of vidofludimus calcium against a placebo in patients with active RMS. The trials are set to enroll approximately 1,050 adult patients across over 100 sites in more than 15 countries, including the United States. The primary endpoint is time to first relapse up to 72 weeks, with key secondary endpoints involving disability progression, T2-lesions volume, and changes in brain volume.
The IDMC conducted the interim futility analysis after approximately half of the planned first relapse events occurred in the double-blind treatment periods of the trials. The analysis aimed to determine if adjustments to the sample size were necessary to prevent an insufficient number of events at the final study readout. The committee recommended no changes to the trial size, and the program is on track for completion in 2026.
Vidofludimus calcium is a small molecule investigational drug that acts as a neuroprotective agent by activating the nuclear receptor related 1 (Nurr1) and selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). This dual mechanism is associated with anti-inflammatory and anti-viral effects, selectively targeting hyperactive immune cells while allowing normal immune function.
Immunic's Chief Medical Officer, Andreas Muehler, M.D., M.B.A., expressed confidence in the initial trial design and relapse rate assumptions, while CEO Daniel Vitt, Ph.D., highlighted the interim analysis as a significant milestone, maintaining a positive outlook on the drug's potential in the oral MS market and its path toward regulatory approval.
The company also anticipates the top-line readout of its phase 2 CALLIPER trial in patients with progressive multiple sclerosis (PMS) in April next year. If the data continues to show a neuroprotective effect, Immunic believes vidofludimus calcium could become a leading oral treatment option for PMS.
This announcement is based on a press release statement from Immunic, Inc.
In other recent news, Immunic Inc. has been the focus of several analyst notes, with firms such as Piper Sandler, EF Hutton, Leerink Partners, and B.Riley maintaining positive ratings on the company. This optimism centers on the potential of Immunic's lead drug candidate, vidofludimus calcium, currently undergoing trials for the treatment of Multiple Sclerosis (MS). Interim results from the Phase 2 CALLIPER trial suggest that vidofludimus calcium may effectively slow disease progression in progressive multiple sclerosis (PMS) patients.
Additionally, the drug has shown antiviral activity, which is being further investigated in ongoing trials. This includes the potential to prevent Epstein-Barr virus reactivation, associated with post-COVID fatigue and possibly contributing to fatigue in MS patients. The company expects to release top-line data from the CALLIPER trial in April next year.
On the financial front, Immunic reported a Q1 2024 loss of $29.6 million, a substantial increase from the previous year's Q1 net loss of $2.3 million. Despite this, the company successfully raised $240 million through a private placement, projected to fund operations through Q3 2025.
In terms of leadership, Immunic extended the contract of its Executive Chairman, Dr. Duane Nash, to December 31, 2025, and increased his monthly base salary. The company also welcomed Simona Skerjanec to its board of directors and appointed Jason Tardio as the new Chief Operating Officer and President. These are the recent developments at Immunic Inc.
InvestingPro Insights
Immunic, Inc.'s (NASDAQ: IMUX) continuation of its phase 3 ENSURE program without modifications aligns with several key financial metrics and insights from InvestingPro. The company's market capitalization stands at $139.62 million, reflecting investor interest in its potential breakthrough treatments for multiple sclerosis.
InvestingPro data shows that Immunic's stock has experienced a significant 26.02% price increase over the last six months, suggesting growing market optimism about the company's clinical progress. This positive trend is further supported by the 32.48% price total return over the past year, indicating sustained investor confidence in Immunic's pipeline.
However, it's important to note that Immunic faces financial challenges typical of biotech companies in the development stage. An InvestingPro Tip reveals that the company is "quickly burning through cash," which is consistent with the substantial investments required for late-stage clinical trials like the ENSURE program. Additionally, Immunic is "not profitable over the last twelve months," with an adjusted operating income of -$93.65 million for the last twelve months as of Q2 2024.
Despite these financial pressures, another InvestingPro Tip highlights that Immunic "holds more cash than debt on its balance sheet," suggesting a degree of financial stability as it progresses through its clinical trials. This could be crucial for maintaining the momentum of the ENSURE program and other pipeline projects.
For investors seeking a more comprehensive analysis, InvestingPro offers 5 additional tips for Immunic, providing deeper insights into the company's financial health and market position.
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