Immunic Inc (NASDAQ:IMUX) – a biotechnology company developing a pipeline of orally administered small molecule therapies for chronic inflammatory and autoimmune diseases - during the three months ending in September advanced its lead drug asset, a nuclear receptor-related 1 (Nurr1) activator vidofludimus calcium IMU-838.
Immunic exited the third quarter with cash, cash equivalents and investments of $59.7 million which it said it expects will fund its operations into September of 2024.
The company’s CEO Dr. Daniel Vitt highlighted that during the quarter, it completed enrollment in its phase 2 CALLIPER trial in patients with progressive multiple sclerosis (PMS) and most recently reported a stronger-than-expected, positive interim biomarker analysis of this trial.
“Notably, the clear separation observed in serum neurofilament light chain (NfL) over placebo in this patient population represents another key milestone for what could potentially be a first-in-class Nurr1 activator for PMS," he said in a statement.
The company plans to report its topline CALLIPER data in April and, assuming it continues to show a neuroprotective effect, the CEO believes the company may be able to position vidofludimus calcium as the first oral treatment for non-active secondary PMS.
It also believes the drug's potential first-in-class ability to activate Nurr1 may meaningfully benefit its phase 3 ENSURE program in relapsing MS (RMS).
“To that end, we continue to enroll patients in our twin phase 3 ENSURE trials and currently expect to report an interim futility analysis in late 2024, with the read-out of the first of the ENSURE trials expected at the end of 2025,” he said.
“If ultimately approved, we continue to believe that vidofludimus calcium, with combined neuroprotective, anti-inflammatory, and antiviral effects, could potentially offer a unique treatment option targeted to the complex pathophysiology of MS."
During 3Q, the company also advanced its second key program IMU-856, an orally available small molecule modulator that targets SIRT6 in patients with celiac disease.
Its Phase 1b trial demonstrated positive effects for IMU-856 when compared to a placebo in four key areas of celiac disease pathology (protection of the gut architecture, improvement of patients' symptoms, biomarker response and enhancement of nutrient absorption) and was observed to be safe and well-tolerated.
“We believe that this highly encouraging data provides initial clinical proof-of-concept for a potential new therapeutic approach to gastrointestinal disorders by promoting regeneration of bowel architecture,” Dr. Vitt said.
“That said, we are currently preparing for clinical phase 2 testing of IMU-856 in ongoing active celiac disease, while also considering further potential clinical applications in other gastrointestinal disorders."
Immunic’s loss for 3Q was $22.8 million or $0.51 per share, compared to a loss of $21.2 million or $0.69 per share in the year-ago quarter.
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