New York-based biotechnology company Immunic Inc (NASDAQ:IMUX) has one or more potential blockbusters in its clinical pipeline.
The firm’s promising lead asset vidofludimus calcium (IMU-838) is an oral drug in Phase 3 clinical trials for patients with multiple sclerosis (MS), a disabling neurological condition caused by the immune system attacking the protective layer around nerve cells, triggering dizziness, muscle atrophy and vision loss.
Despite medication, most patients inch towards disability over time and finally may end up in a wheelchair. Fortunately, Immunic offers a glimmer of hope. Piper Sandler has awarded a $28 price target on the company’s shares based on its analysis that IMU-838 will be approved by the US Food and Drug Administration (FDA) for relapsing multiple sclerosis by 2026.
Immunic co-founder and CEO Daniel Vitt has worked on the company’s two most advanced assets from the lab until they’ve gone into clinical trials.
In 1997, straight out of university, Vitt built his first company 4SC AG around a pipeline of anti-inflammatory and oncology molecules. Later in 2016, Vitt co-founded Immunic to focus on immunological diseases, including IMU-838. Thanks to his tenacity, IMU-838 has now reached advanced Phase 3 pivotal trials.
“You can only raise the money and convince investors about molecules if you yourself are convinced,” Vitt told Proactive.
“I was driven by IMU-838 as it has shown great safety for indications in the autoimmune and inflammation space. Data has also shown the neuroprotective potential of IMU-838. The activation of Nurr1 has been linked to IMU-838’s neuroprotective effects and its ability to reduce disability worsening in MS patients. They deserve help — we need to get this on the market.”
As an inventive computer scientist and chemist, Vitt spent time during his PhD doing something unusual — quantum chemical calculations of reactions. He used it for designing active molecules, which he first did for malaria as a part of a WHO program. Later, he developed algorithms and used that to spinout 4SC AG on the back of his university computer modeling work.
“If things go well, I’ll have been through the whole cycle from drug discovery, preclinical research, clinical trials, to FDA review and post-marketing,” mused Vitt.
Exciting clinical catalysts
The firm’s ENSURE program, along with the supportive Phase 2 CALLIPER trial in progressive MS, which is designed to corroborate the neuroprotective potential of IMU-838, is giving Immunic a plank to position IMU-838 as a preferred oral drug.
Significantly, data from the interim analysis of the Phase 2 CALLIPER trial of IMU-838 in progressive MS is expected in the second half of this year, and topline data by end-2024.
“If approved, IMU-838 can be a unique treatment targeting the biology of MS with combined anti-inflammatory, antiviral and neuroprotective effects,” said Vitt.
The intricate design of the ENSURE program provides a straightforward path to regulatory approval in relapsing MS.
“When we designed the Phase 3 studies, we spent a year in discussions with regulatory and medical experts on what is the right strategy — that brought us to the ENSURE twin studies,” noted Vitt.
Data from the interim analysis of the ENSURE program is expected in late-2024, with the read-out of the first of the ENSURE trials expected at the end of 2025 and the second one in early-2026.
By this time, Immunic will have enough evidence on IMU-838’s safety and effectiveness to meet requirements for marketing approval and submitting a new drug application (NDA) to the FDA.
“By 2026-2027, we can realistically expect approval,” said Vitt.
Immunic said there’s a huge unmet medical need for improving or preventing the worsening of disability.
“This is important in two indications in multiple sclerosis, which is relapsing MS where we have the ongoing Phase 3 ENSURE trials, and in progressive MS where we have the ongoing Phase 2 study,” said Vitt.
“It was demonstrated last year by scientists that the Epstein-Barr virus not only plays a role as the root cause of MS, but also in the progression of MS. In this context, out drug’s antiviral activity is important.”
Data from Immunic’s Phase 2 EMPhASIS trial in relapsing-remitting multiple sclerosis (RRMS) shows long-term open-label treatment with IMU-838 was linked to a low rate of confirmed disability worsening. It also stacks up favorably against historical trial data for approved MS meds, both regarding safety and activity.
Beating ulcerative colitis
Immunic recently shared positive data from the maintenance phase of its Phase 2b CALDOSE-1 trial of IMU-838 in patients with moderate-to-severe ulcerative colitis (UC), that causes chronic inflammation and ulcers in the superficial lining of the large intestine.
"We’ll explore exciting options for the UC program, as well as other inflammatory bowel disease (IBD) indications,” said Vitt.
IMU-856 is a game changer
Immunic also reported impressive results from its Phase 1b clinical trial of IMU-856 in patients with celiac disease. The molecule has shown a beneficial effect on gut health by helping to modulate, stabilize and enhance expression of the Sirtuin 6 (SIRT6) protein in the gastrointestinal (GI) tract.
“The data is game-changing. IMU-856 targets Sirtuin 6 which helps in renewing and restoring the epithelial layer of the bowel and gut,” said Vitt.
“It is helping to repair the tissue — it's a different approach from what others are doing in the GI space. The phase 1b data in celiac disease patients far exceeded our expectations."
There’s no FDA-approved drug for celiac disease, so the only course of action for celiac patients is to adhere to a gluten-free diet, despite evidence that diet alone isn’t enough to ward off symptoms like a “leaky gut” and intestinal damage. Two million people in the US have celiac disease.
“IMU-856 avoids suppression of immune cells and may therefore maintain immune surveillance for patients during therapy, representing a distinct advantage compared to potentially immunosuppressive medications,” said Vitt.
He highlighted IMU-856’s potential beyond celiac disease, to include GI diseases such as ulcerative colitis, Crohn's disease, or irritable bowel syndrome with diarrhea, which are all acerbated by compromised intestinal barrier function.
Immunic is now preparing for a phase 2b clinical trial of IMU-856 in celiac disease patients, while also considering other indications.
Strong cash runway
As of March 31, 2023, Immunic had $97.1 million, which it said would fund its operations into the fourth quarter of 2024.
“We are well financed. It's really about the clinical trial costs of a big trial with over 140 sites in the world. All in all, we're financed right into 4Q 2024.”
Immunic may not be closed to alternative options.
“Big pharma companies are looking for complements to their pipelines,” said Vitt. “We have seen super big deals in the gastrointestinal space – basically in exactly what we’re doing with IMU-856.”
Merck acquired Prometheus Biosciences for $10.8 billion with a Phase 2 proof-of-concept in ulcerative colitis and data in Crohn’s.
“The Merck deal shows that we are in the right space. There’s fierce competition among companies for good assets like the one we have. This may offer us a good alternative to a plain equity raise,” said Vitt.
High-volume drug market
Immunic has caught Wall Street’s eye with its innovation in big indication areas.
Analysts at Ladenburg Thalmann reiterated their ‘Buy’ rating and $15 price target, excluding IMU-856 from their valuation, which they said represented even more potential upside. Immunic trades around $1.74 on the Nasdaq.
If IMU-838 is successful, Immunic will be a dominant player in the high-volume $23 billion multiple sclerosis drug market.
“The biggest player on the sales side is Ocrevus made by Roche, among others,” said Vitt.
“We see ourselves in four MS segments and together we may have a blockbuster potential above $1 billion. It will depend on the data at the end, as the better we are at achieving the primary and key secondary endpoints, the more attractive it will be for early use and relapses. Then if we get good data on confirmed disability prevention it opens up segments which are currently not treated.”
Vitt also underscored that in the GI space with celiac, there’s no approved treatment.
“We are for the first time trying to fix the leaky gut to restore the proper gut wall function and the epithelial layer,” noted Vitt. “That’s a broad approach and investors should pay attention to our positive clinical data on IMU-856.”
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
Follow her on Twitter: @UttaraProactive