Immunic IMUX was up almost 6% on Apr 5, after it reported positive results from the maintenance phase of the phase II (CALDOSE-1) study evaluating its lead candidate, vidofludimus calcium (IMU-838) to treat patients with moderate-to-severe ulcerative colitis (UC).
The maintenance study found a dose-linear increase in clinical remission and endoscopic healing at week 50for vidofludimus calcium compared to the placebo. The 30mg dose of vidofludimus calcium, which showed a 33.7% absolute improvement in clinical remission over the placebo, was a statistically significant improvement. The 30 mg once-daily dose of the drug also demonstrated statistically significant rates of endoscopic healing at week 50. The study also confirmed that vidofludimus calcium had a favorable safety profile and was well tolerated, with no new safety signals observed.
Data from the induction phase of the study reported in June 2022 showed clinical remission rates of 14.7% for the pooled vidofludimus calcium arms and 3.3% for the placebo arm among patients who are not being treated concurrently with chronic corticosteroids.
The company believes that the positive results from the CALDOSE-1 study confirms that vidofludimus calcium acts impressively in the absence of chronic corticosteroid co-administration. The drug has also been found to have a high response rate in replacing steroids among steroid-dependent UC patients.
Shares of Immunic have plunged 86.3% in the past year compared with the industry's 15.9% decline.
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However, the company does not intend to initiate phase III development of vidofludimus calcium in UC on its own, which suggests that it might look for a partner for additional funding. It is planning to explore other inflammatory bowel disease indications.
Considering the positive results, the company plans to focus its resources on advancing vidofludimus calcium and IMU-856 programs. In order to do so, Immunic will be deprioritizing the clinical portion of its izumerogant development program in psoriasis and castration-resistant prostate cancer.
The company’s early-stage study of IMU-856 to treat patients with celiac disease is proceeding rapidly. It expects to report data from the part C portion of the study in the current quarter.
Immunic, Inc. Price and Consensus
Immunic, Inc. price-consensus-chart | Immunic, Inc. Quote
Zacks Rank & Stocks to Consider
Currently, Immunic has a Zacks Rank #3 (Hold).
Some better-ranked stocks for investors interested in the same sector are CRISPR Therapeutics CRSP, Kala Pharmaceuticals KALA and Kodiak Sciences KOD, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
Loss per share estimates for CRISPR have narrowed from $8.21 to $7.35 for 2023 in the past 60 days.
The company's earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, the average surprise being 3.19%. CRSP's shares have plunged 29.9% in the past year.
Loss per share estimates for Kala have narrowed from $19.67 to $15.35 for 2023 and from $14.41 to $13.12 for 2024 in the past 60 days. The company's shares have plunged 74.3% in the past year.
KALA's earnings beat estimates in two of the last four quarters and missed the mark in the other two, the average surprise being 11.56%.
Loss per share estimates for Kodiak Sciences have narrowed from $5.66 to $5.3 for 2023 and from $5.18 to $4.71 for 2024 in the past 60 days.
The company's earnings beat estimates in three of the last four quarters and missed the mark in one, the average surprise being 0.96%. KOD's shares have plunged 35% in the past year.
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