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QuBiologics new phase 2 trial recruiting soon

Calling all Canadians! I got this communiqué from QuBiologics and wanted to share:

"We're getting closer to the launch of our #Canadian phase 2 clinical trial for adults with moderate to severe #CrohnsDisease (www.quibd.com).

If you live in #Canada, think you'd like to participate and want more info, sign up here and say "Yes, please" http://ow.ly/ihIl30i1Sif"

Good Luck!
 

Lady Organic

Moderator
Staff member
I have contacted the team today and waiting for an answer on when it starts, how we qualify and if traveling expenses are still paid. I think they were right?

I may be interested if participation is not too regular and complicated for an out of province patient. I think they have 4 points of services now if Im correct, but none in Québec.
 
I hope you get into the trial! I really think this is one of the most promising drugs in development right now. I’d love to get feedback and updates from someone actually participating in the trial.

I pray this makes it through the development process and gets approved in the future.

Good luck, and keep us updated!
 
Lady Organic, did you see that they are having a webinar about the trial?

“Sign up for our webinar & join Dr. Hal Gunn on Monday March 5th 2018 at 4 pm PST (7 PM EST) to learn more about the trial design and the inclusion/exclusion criteria. There will be a 30 minute presentation followed by 30 minute Q&A session.

Just send us an email to info@quibd.com with the word "Webinar" in the subject line and we'll register you and send log-in information to participate.“
 

Lady Organic

Moderator
Staff member
I attended the webinar yesterday. It was interesting but we couldnt hear all the answers from Dr Gunn due to sound system difficulties. Hopefully, there will be a transcript soon of the webinar.

The upcoming CD trial will start this month with 20 first Canadian participants who will all receive the real medication for 1 year.

A second arm will start short after in the fallowing months with 150 participants if i remember correct. 2/3 will receive the medication for 1 year and 1/3 the placebo. Unfortunately the placebo arm wont have the chance to receive the real medication down the road. Americans will be allowed for this trial if I understood correctly.

Disease must be classified from moderate to severe based on a colonoscopy and evaluation of clinical symptoms of the trial experimentors.

I asked the question if the treatment could help extraintestinal manifestions, such as arthritis, and the answer was ''no''. Dr Gunn answered that QBCO was gut specific.

I also asked the question if participants who would respond positively could pursue the treatment as a compassionate treatment after the trial and he answered that he would try to get approval from Health Canada.

Dr. Gunn mentioned that it would take at least 4 years before possible commercialization of the treatment. :frown:
 
Thank you Lady Organic! I wonder though, if it puts you in remission whether that would help the other manifestations of the disease, even if the treatment is gut specific, since everything is tied together. Do you think you will try it?
 

Lady Organic

Moderator
Staff member
With all the patients he already fallowed in previous trials, i think he responded knowing it didnt help many patients. But that's just my feeling... Especially for those of us whose EIMs run independantly of disease activity, thats even less of a possibility I believe.
At this point, I would not qualify as I just reached remission on prednisone. So I could wait for the 150 -patients arm in case of relapse, but having a 1 out 3 chances of not receiving the treatment is not something I am much interested in. i am highly reluctant letting my disease going to moderate in order to have a chance to participate as well. I have become highly protective of my colon and I manage to not letting things go out of control. I want to get things under control before it reaches moderate level of disease activity and live minimal suffering and anxiety. If I relapse again, I am most likely going to go on Humira, stelara or vedolizumab and want fast intervention.
 
RESTORE: Crohn's Disease Phase 2 Clinical Trial

Hello,

Thank you for your continuous interest in Qu Biologic's investigational treatment QBECO Site Specific Immunomodulator (SSI). I would like to provide an update on RESTORE, our ongoing phase 2 clinical trial.

• Currently enrolling patients with moderate-to-severe Crohn’s disease

• The study will enroll a total of 20 participants in 3 sites located in Vancouver, BC; New Westminster, BC and Hamilton, ON.

• The study is open-label meaning that everyone receives QBECO investigational treatment for 52 weeks.

• Study related travel will be paid for by Qu Biologics and the study investigational drug, QBECO, and procedures are provided at no cost to participants.

• Anyone who is interested in joining the RESTORE study is invited to find out if they may be eligible by filling out a simple questionnaire at www.restoretrial.ca. Specific questions about RESTORE can be directed to the study’s recruitment nurse Andrea Cameron by email (cdtrial@quibd.com) or phone (1-877-223-8637).

Best wishes!
 

Lady Organic

Moderator
Staff member
Thank you so much Dr Gunn for the update.

I am relapsing right now. I am highly tempeted to try to enroll. This may be my chance. I'll reach the nurse next week for a discussion.
Thanks a lot!
 
Exciting news although it a bit of a disappointment to hear the it won't be commercialised for another 4 years. I hoping it was going to be more like 2 years at this stage...
 
Hey everyone, I am in the study. I have given my self my 8th injection. So far I have noticed a slight reduction in bowel movements. Also the overall pain factor has started to decrease. I will keep everyone posted on how I am doing. HOPEFULLY,me being a lab rat will help bring some light at the end of the tunnel for all of us.

The study is for 56 weeks. I hope by this time next year I am home free.

Two of the requirements for the study are you cant be on and(and I think) you can never have taken a biologic. You also can never have had any surgery. They will ask you over the phone all the other questions needed to make sure you qualify. If you do qualify be prepared to be treated as a lab rat. Lots of blood and stool tests before you go into the study.

Tom
 
Hey everyone, I am in the study. I have given my self my 8th injection. So far I have noticed a slight reduction in bowel movements. Also the overall pain factor has started to decrease. I will keep everyone posted on how I am doing. HOPEFULLY,me being a lab rat will help bring some light at the end of the tunnel for all of us.

The study is for 56 weeks. I hope by this time next year I am home free.

Two of the requirements for the study are you cant be on and(and I think) you can never have taken a biologic. You also can never have had any surgery. They will ask you over the phone all the other questions needed to make sure you qualify. If you do qualify be prepared to be treated as a lab rat. Lots of blood and stool tests before you go into the study.

Tom
Sounds great - congratulations of getting on the study hopefully you'll soon be well for a long time, even off all medications! Best of luck!

I think its just that you are not to currently be taking a on biologic - people who have been on them in the past are eligible.

Is there anything else you can tell us about the study? How its going or any other news?
 
As of today I am doing fine. I did have a small flare up at the beginning of April. I was on 20 mg of pred. for the first phase(4 months) of the trial. After my last scope I was told to taper off the pred.(which I did at 5mg intervals every 7 days). When I was down to 5 mgs of pred. I started to feel the same discomfort I always get before an attack. I started to pass blood on the first week of April and my bowel movements increased. This lasted for about 5 days and then quit. I am still symptom free and have a scope coming up on the 21 of May. I am hoping my cal protecin levels have dropped some more. Now that I am off the pred. I sometimes get a red mark and a small lump at the injection site.
 
My latest test results are in. ALL my blood work is normal. My CRP levels(high sensitivity) have now come down and are at 0.6. Anything below 1.0 is good.

My Cal Protectin level is still high(180) but has dropped another 600 points from my last test. I am now symptom free. My Gastro. is quite happy(as am I ) with the results. My next scope won't be until mid Dec. I am hoping by this time I will be completely Crohn's free.

Tom.
 
Does anyone know what the implications of this treatment are for people who are in remission?

For example I am currently in 'remission' with Entyvio but obviously E is a treatment that suppresses symptoms rather than treating the cause. On the other hand QBECO aims to remove the underlying trigger for the disease, restoring innate immune function and possibly curing the condition. So surely even though I am in remission with E, the underlying trigger for the disease still exists in my body and taking QBECO could potentially resolve this?
 
It's been 8 months since I finished the study. I have had a couple VERY minor flareups lasting a couple of days but overall I am VERY happy with the results. Not taking any other meds. I hope I stay this way. Never thought it possible to get off of Pred., Asacol(both oral and rectal).
 
It's been 8 months since I finished the study. I have had a couple VERY minor flareups lasting a couple of days but overall I am VERY happy with the results. Not taking any other meds. I hope I stay this way. Never thought it possible to get off of Pred., Asacol(both oral and rectal).
That’s very good to hear, I hope this state of goodness will continue for you. Thanks for sharing.
 
I just read this:

Qu Biologics Completes Enrollment in First Stage of Phase 2 Clinical Trial in Moderate to Severe Crohn’s Disease
VANCOUVER, British Columbia – Dec. 18, 2019 (GLOBE NEWSWIRE) — Qu Biologics Inc., a biopharmaceutical company developing Site Specific Immunomodulators (SSIs), a novel immunotherapy platform designed to restore innate immune function, is pleased to announce the completion of enrollment for the first stage of the RESTORE clinical trial, “A Phase 2, Multi-center, Randomized, Double-Blind, Placebo-Controlled Study of QBECO SSI for the Induction and Maintenance of Clinical and Endoscopic Remission in Subjects with Moderate to Severe Crohn’s Disease”.

In this open-label first stage of a 170-patient study, 20 patients with moderate to severe Crohn’s disease will be treated for up to 52 weeks with the novel investigational agent, QBECO SSI, which is designed to restore, rather than suppress, immune function. Throughout the study treatment period, clinical symptom and endoscopic outcome data are being evaluated to determine the appropriate remission induction treatment period for the study’s next stage. The study also includes important exploratory endpoints correlated with QBECO SSI response, including immune biomarkers, histology and microbiome assessment.

This trial is a follow-on study to Qu’s first study in CD, which was a 68-patient randomized placebo-controlled trial designed to assess improvement of clinical symptoms with QBECO treatment over a 16-week period. This 68 patient study demonstrated a substantial decrease in Crohn’s disease activity index (CDAI) score after 8 weeks of treatment with continued improvement over the 16-week course of study treatment. Qu’s QBECO SSI achieved statistically significant improved response compared to placebo in anti-TNFα naïve patients in this small study, demonstrating proof-of-concept of this novel immunomodulatory approach. The results of Qu’s previous CD trial were published earlier this year in Frontiers in Medicine.

“Completion of enrolment in this first stage of our RESTORE Phase 2 study is an important milestone and we would like to thank the patients for their participation in this clinical trial,” stated Qu Biologics CEO Hal Gunn. “Through their contribution together with the Investigators and study staff, this trial will help us better understand the contribution that QBECO SSI may have on the treatment of this challenging disease and on improving lives of those with Crohn’s disease.”

The 150 patient second stage of the RESTORE Phase 2 randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the safety and efficacy of QBECO SSI for the treatment of moderate to severe CD subjects in Canada, the US and Europe. The endpoints of this study include the induction of clinical and endoscopic remission at week 16 and 26 and maintenance of remission assessed at week 52.

For more information about Qu Biologics and the science behind SSIs, please visit www.qubiologics.com.

Also this: https://www.quibd.com/phase-2-clinical-trial-trial/
 
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