Immunotherapeutics OSE: 90%+ Patient Success
OSE Immunotherapeutics Reports Positive Lusvertikimab Extension Data in Hemorrhagic Rectocolitis
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NANTES, France, May 5, 2025, 6:30 p.m. CET – OSE Immunotherapeutics SA (ISIN: FR012127173; Mnemo: OSE) announced that a significant majority – over 90% – of patients with hemorrhagic rectocolitis (RCH) who initially responded to Lusvertikimab treatment maintained symptomatic remission during a 24-week extension period. Moreover, 61% of patients who did not achieve symptomatic remission after the initial 10 weeks of treatment experienced remission by the end of the extension phase using an 850 mg dose. The company also reported that Lusvertikimab was well-tolerated throughout the extension.
Lusvertikimab Data Presented at Digestive Disease Week 2025
These findings, stemming from the open-label extension (OLE) of the Phase 2 Cotikis study, which assessed the anti-IL-7 receptor monoclonal antibody Lusvertikimab in RCH, were presented at Digestive Disease Week (DDW) in San Diego, held May 3-6, 2025. These results build upon the initial induction phase data presented at the ECCO 2025 congress in February.
Executive Commentary
“This new data provides details on the longer term profits and security of Lusvertikimab in the RCH, with 89 % of the participants continuing the study in the OLE and 87 % period having completed it. More than 90 % of patients treated with Lusvertikimab in symptomatic remission at the end of the induction phase reported a lasting response to treatment, and Lusvertikimab has also demonstrated very good safety and very good tolerance throughout the study which included 24 weeks in the high dose for all patients,” said Sonia Montgomery, Chief Progress Officer at OSE Immunotherapeutics.
Montgomery added, “We also observed an increase in symptomatic remission rates in all groups during the OLE period, the group having received the dose of induction of 850 mg showing this improvement of the effect after an additional dose. OLE data support the potential of Lusvertikimab as monotherapy with a positive impact on symptom management and patient quality of life.”
Arnaud Bourreille, associate professor in gastroenterology, Nantes university hospital center and the study’s main investigator, noted, “Despite a wide range of approaches for the management of hemorrhagic rectocolitis, it can be challenging to obtain a remission of symptoms and generally, only 25 to 30 % of people can reach and maintain the remission of symptoms with one of the available treatments. For people living with rectocolitis hemorrhagic,these results represent an vital step to cope with this therapeutic ceiling.”
Key Findings from the Extension Period
- 89% of participants entered the OLE period, with 87% completing the study.
- symptomatic remission rates improved across all dosage groups during the OLE period, suggesting enhanced efficacy over time.
- 92% of participants who achieved symptomatic remission during the induction period maintained it throughout the OLE period.
- 61% of participants who did not initially achieve symptomatic remission reached it during the OLE period.
- 85% of participants in the placebo arm during the induction period achieved symptomatic remission after receiving the 850 mg dose during the OLE period.
- 82% of participants achieved remission of rectal bleeding by the end of the OLE period.
- lusvertikimab demonstrated a favorable safety profile and was well-tolerated throughout the 34-week treatment period, with no increase in the rate or severity of infections.
About the Cotikis Study Design
The Cotikis study, a 50-week clinical trial, employed a randomized, double-blind, placebo-controlled design. The study consisted of:
- A 10-week induction period evaluating two doses (450 mg and 850 mg) of Lusvertikimab against placebo.
- A 24-week open-label extension (OLE) period where all patients received infusions of Lusvertikimab 850 mg every 4 weeks.
- A 16-week safety monitoring period without treatment.
Results from the induction phase, previously presented at the ECCO congress in February 2025, demonstrated that both doses (450 mg and 850 mg) met the primary efficacy endpoint (modified MAYO score at week 10) and showed statistically significant and clinically meaningful improvements across secondary clinical, endoscopic, and histological criteria.
References
- Bourreille A et al., Oral presentation #913, Digestive Disease Week, 5 May 2025, San diego, USA.
- Bourreille A et al.,J Crohn’s & Colitis 2025; 19(1):i71–i72. doi: 10.1093/ecco-jcc/jjae190.0036.
- EU Clinical Trials register: CoTikiS study record (2020-001398-59), available via www.clinicaltrialsregister.eu [Accessed May 2025].
- Yanofsky R & Rubin DT, J Can.Assoc.Gastroenterology 2025; 8 (S2): S6 -S14, Doi: 10.1093/JCag/GWAE058.
- The Berre C et al. Lancet 2023; 402 (10401): 571–584, two: 10.1016/S0140-6736 (23) 00966-2.
- Symptomatic remission on Mayo patient-reported outcomes 2, PRO2 (stool frequency subscore + rectal bleeding subscore) = 0 or 1 and rectal bleeding subscore = 0.
- Responders are defined as patients with endoscopic score of 0 or 1 at Week 10.
About Digestive disease Week (DDW)
Digestive Disease Week® (DDW) is a premier international forum for physicians, researchers, and academics in gastroenterology, hepatology, endoscopy, and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary tract (SSAT), DDW presents nearly 6,000 abstracts and hosts over 1,000 oral presentations on the latest advancements in research, treatments, and technology. More information is available at www.ddw.org.
About OSE Immunotherapeutics
OSE Immunotherapeutics is a biotechnology company focused on developing first-in-class immunotherapies in immuno-oncology (IO) and immuno-inflammation (I&I) to address unmet medical needs. The company collaborates with academic institutions and biopharmaceutical companies to develop and commercialize transformative drugs for patients with serious illnesses. OSE Immunotherapeutics has locations in Nantes and Paris and is listed on Euronext.
Further information about OSE Immunotherapeutics’ assets can be found on the company’s website.
Forward-Looking Statements
This press release contains forward-looking statements regarding OSE Immunotherapeutics. These statements are not historical facts but rather reflect the company’s current expectations and assumptions based on its experience and perception of historical trends, current economic and industry conditions, future developments, and other factors. These statements are subject to risks and uncertainties that could cause actual results and developments to differ materially from those expressed or implied in such statements. These risks include those described in the public documents filed by OSE Immunotherapeutics with the AMF. OSE Immunotherapeutics undertakes no obligation to update these forward-looking statements, except as required by applicable laws and regulations.
Here’s a Q&A-style blog post based on the provided article, designed for high quality, user engagement, and SEO optimization:
Lusvertikimab for Hemorrhagic Rectocolitis: Your Questions Answered
Welcome! this article delves into the promising results of Lusvertikimab, a potential new treatment for hemorrhagic rectocolitis (RCH), based on recent announcements from OSE Immunotherapeutics. We’ll explore these findings in a clear, easy-to-understand Q&A format, giving you the facts you need.
Q: What is hemorrhagic rectocolitis (RCH)?
A: hemorrhagic rectocolitis (RCH), frequently enough referred to as ulcerative colitis (UC) or Inflammatory Bowel Disease (IBD), is a chronic inflammatory condition that affects the large intestine (colon) and rectum. The primary symptom is inflammation that causes ulcers to form in the lining of the colon and rectum. The disease can cause symptoms like:
Rectal bleeding: passing blood during bowel movements.
Abdominal pain and cramping: Discomfort in the abdomen.
Diarrhea: Frequent bowel movements, often with blood or mucus.
Urgent need to defecate: Feeling the need to have a bowel movement promptly.
Fatigue: General tiredness and lack of energy.
Weight loss: Unintentional loss of weight.
RCH,like other forms of ulcerative colitis,can considerably impact a patient’s quality of life.
Q: What is Lusvertikimab, and what is it being developed to treat?
A: Lusvertikimab is an anti-IL-7 receptor monoclonal antibody. This means it is a targeted therapy, designed to block the action of a specific protein (IL-7) in the body. It’s being developed by OSE Immunotherapeutics as a potential treatment for hemorrhagic rectocolitis (RCH). The goal is to reduce inflammation and improve the symptoms of the disease.
Q: What did OSE Immunotherapeutics announce on May 5, 2025?
A: OSE Immunotherapeutics announced positive results from the open-label extension (OLE) of its Phase 2 Cotikis study. The data showed that Lusvertikimab demonstrated continued efficacy and a favorable safety profile in patients with hemorrhagic rectocolitis (RCH).
Specifically,the company reported:
Maintenance of remission: Over 90% of RCH patients who initially responded to Lusvertikimab maintained symptomatic remission during a 24-week extension period.
Improved Remission Rates: 61% of patients, that didnt experience remission at the beginning of the study, reached it by the end of the new study phase by using the medicine Lusvertikimab.
Q: Where was this data presented?
A: this data was presented at Digestive Disease Week (DDW) in San Diego, held from May 3-6, 2025.This is a prominent international forum for gastroenterology and related fields.
Q: What were the key findings from the extension period (OLE) of the Cotikis study?
A: The main findings of the OLE period include:
High Participation and completion: 89% of participants enrolled in the OLE period, and a high 87% completed the study.
Enhanced Symptomatic remission: Symptomatic remission rates improved across all dosage groups during the OLE period, suggesting improved efficacy over time.
Sustained Remission: Of those who achieved symptomatic remission during the initial induction phase, 92% maintained it throughout the OLE.
Remission for Non-Responders: 61% of those who didn’t initially achieve symptomatic remission reached it during the OLE period. This is a very very high number.
Remission in Placebo Group: 85% of the patients from the placebo arm during the induction period achieved symptomatic remission after receiving the 850 mg dose during the OLE period.
Rectal Bleeding Betterment: 82% of participants achieved remission of rectal bleeding by the end of the OLE period.
Favorable Safety Profile: Lusvertikimab was well-tolerated throughout the 34-week treatment period, with no increase in infections.
Q: What does “symptomatic remission” mean in this context?
A: symptomatic remission refers to a reduction or the disappearance of the symptoms of RCH. In this study, it’s defined as when a patient’s stool frequency subscore and rectal bleeding subscore on the Mayo patient-reported outcomes (PRO2) is 0 or 1, and their rectal bleeding subscore is 0. This means the patient is experiencing minimal or no symptoms like more normal bowel movements and no blood in their stools.
Q: What was the design of the Cotikis study?
A: The cotikis study was a 50-week clinical trial that used a randomized, double-blind, placebo-controlled design. It consisted of three phases:
Induction Period (10 weeks): Two groups (450mg and 850mg) received Lusvertikimab against a placebo group.
Open-label Extension (OLE) Period (24 weeks): All patients received infusions of Lusvertikimab 850 mg every 4 weeks.
Safety Monitoring Period (16 weeks): No treatment was administered.
Q: What are the potential benefits of Lusvertikimab for people with RCH?
A: The data suggests that Lusvertikimab could offer several potential benefits:
Effective Symptom Control: The drug has shown success in achieving and maintaining symptomatic remission, including a reduction of bleeding episodes.
Improved Quality of Life: Remission of symptoms can lead to a significantly improved quality of life for patients.
Potential as Monotherapy: The data supports Lusvertikimab’s potential as a monotherapy, meaning it might very well be used as a single treatment without the need for other medications.
Q: What do the experts say about these results?
A: Sonia Montgomery, Chief Progress Officer at OSE Immunotherapeutics, stated: “This new data provides details on the longer term profits and security of Lusvertikimab in the RCH, with 89% of the participants continuing the study in the OLE and 87% period having completed it. More than 90% of patients treated with Lusvertikimab in symptomatic remission at the end of the induction phase reported a lasting response to treatment, and Lusvertikimab has also demonstrated very good safety and very good tolerance throughout the study which included 24 weeks in the high dose for all patients.”
Arnaud Bourreille, associate professor in gastroenterology and the study’s main investigator, noted that Lusvertikimab represents a vital step to cope with this therapeutic ceiling sence there are currently few treatments that can help people to obtain and maintain the remission of symptoms.
Q: What does this mean for people with RCH?
A: The results from the Cotikis study are very encouraging.They indicate that Lusvertikimab could be a promising new treatment option for RCH. While this medication is not on the market yet, and more studies are needed, the positive data points to a potential new choice for individuals struggling with this condition.Patients should discuss their options with their doctors.
Q: What are the next steps for Lusvertikimab?
A: Further clinical trials and regulatory approvals will be necessary before Lusvertikimab can become available to patients. OSE Immunotherapeutics will likely move forward with plans to continue progress and seek approval from regulatory authorities.
Q: Where can I find more information about DDW, OSE Immunotherapeutics, and the references mentioned?
A:
Digestive Disease Week (DDW): Visit http://www.ddw.org
* OSE Immunotherapeutics: Check the company’s