Positive Phase 2 Data for Omilancor in Crohn Disease, Ulcerative Colitis Presented at ACG

Andrew Leber, PhD

Credit: NIMML Institute

Data from a pair of phase 2 trials presented at the American College of Gastroenterology (ACG) 2023 Annual Scientific Meeting is providing new insight into the effects of omilancor in patients with Crohn disease (CD) and ulcerative colitis (UC).

Results of the studies, which were presented by Andrew Leber, PhD, scientific director at the NIMML Institute, detail the effects of the oral, gut-restricted LANCL2 agonist in these patients, with results pointing to improved patient symptoms and improved disease severity across multiple clinical outcomes.^1,2

“We look forward to continuing to realize the significant potential of omilancor as the first-in-class LANCL2 agonist for UC and additional autoimmune indications including Crohn’s disease and psoriasis,” said Josep Bassaganya-Riera, PhD, president and CEO of NImmune in a press release announcing the presentation of the results at ACG 2023.³

Omilancor for CD

In the phase 2 trial for CD, adult patients with CD Activity Index (CDAI) 220-450 and Simple Endoscopic Score for CD (SES-CD) ≥ 6 were randomized in a 1:1 ratio to receive omilancor (n = 12) or placebo (n = 11) for 12 weeks. The primary endpoint was clinical remission, defined as the proportion of patients with CDAI < 150 at week 12. Key secondary endpoints included clinical response (CDAI decrease from baseline ≥ 100 points or CDAI < 150), PRO-2 remission (abdominal pain subscore of 0 or 1 and a stool frequency subscore ≤ 3), and fecal calprotectin normalization (< 250 µg/g).¹

Upon analysis, 25.0% of patients in the omilancor group achieved clinical remission relative to 9.1% in the placebo group (Δ = 15.9). Investigators noted similar effect sizes were observed within biologic experienced (Δ = 20.0) and biologic naïve (Δ = 14.3) subpopulations.¹

Among participants taking omilancor, 41.7% of patients achieved clinical response and PRO-2 remission compared to 9.1% in the placebo group (Δ = 32.6). Fecal calprotectin was normalized in 33.3% of patients in the omilancor group relative to 14.3% in the placebo group (Δ = 19.0). Investigators pointed out the mean percent change from baseline in CDAI score and fecal calprotectin were also greater in the omilancor group relative to placebo.¹

Oral omilancor was well tolerated with no trends in AE profile observed and no SAEs related to the study drug. Investigators noted overall patterns in biomarkers and target engagement were consistent with those previously observed in ulcerative colitis patients treated with omilancor.¹

“Treatment with omilancor resulted in consistent improvement of patient symptoms and disease severity across multiple clinical outcomes in a first study of Crohn’s disease patients,” wrote investigators.¹

Omilancor for UC

In the phase 2 trial for UC, patients with Mayo Clinic score (MCS) 4-10 and endoscopic subscores ≥ 2 were randomized in a 1:1:1 ratio to receive omilancor 440 mg, omilancor 880 mg, or placebo for 12 weeks. The primary endpoint was clinical remission after 12 weeks, defined as no rectal bleeding, stool frequency ≤ 1, and endoscopic appearance ≤ 1.²

Patients who achieved clinical response were eligible for blinded maintenance treatment in a treat-through design. A modified intent-to-treat (mITT) population was defined by patients with rectal bleeding > 0, histological activity, and elevated fecal calprotectin at baseline.²

Upon analysis, clinical remission was induced in 30.4% of patients treated with omilancor relative to 3.7% of patients in the placebo group in the mITT population (Δ = 26.7; P = .01). Endoscopic remission, defined as MES < 2, was induced in 41.7% of patients treated with omilancor relative to 18.6% of patients given placebo (Δ = 23.1; P = 0.07). Histological remission, defined as a Geboes score < 3.1 with absence of neutrophils in the lamina propria, was induced in 41.7% of patients treated with omilancor relative to 22.2% of patients given placebo (Δ = 19.5; P = 0.14).²

Investigators noted durable remission was achieved in 38.5% of patients treated with omilancor relative to 21.4% of patients given placebo (Δ = 17.1; P = .05). In the same population, endoscopic response was achieved in 73.1% of patients treated with omilancor relative to 53.6% of patients given placebo (Δ = 19.5; P = .02). Omilancor was well tolerated with no trends in AE profile observed and no dose-limiting toxicities.²

References:

1. Leber A, Hontecillas R, Nuria JT, et al. P2215 - Efficacy and Safety of Omilancor in a Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of Patients With Crohn’s Disease. Paper presented at: ACG 2023 Annual Scientific Meeting. Vancouver, Canada. October 20 – 25, 2023.
2. Leber A, Hontecillas R, Nuria JT, et al. P2216 - Efficacy and Safety of Omilancor in a Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of Patients With Ulcerative Colitis. Paper presented at: ACG 2023 Annual Scientific Meeting. Vancouver, Canada. October 20 – 25, 2023.
3. BioSpace. NImmune Biopharma Announces Positive Results of Omilancor in Ulcerative Colitis and Crohn’s disease at the American College of Gastroenterology 2023 Annual Scientific Meeting. October 23, 2023. Accessed October 30, 2023. https://www.biospace.com/article/releases/nimmune-biopharma-announces-positive-results-of-omilancor-in-ulcerative-colitis-and-crohn-s-disease-at-the-american-college-of-gastroenterology-2023-annual-scientific-meeting/