QBECO-SSI Clinical Trial

xy123- I haven't been following much since I've been in remission; until this week with fistulas again...

May I ask if you are getting this in Hamilton? Any idea if you can join the study with fistulas? I was looking into RESTORE study but was doing so well on Stelara.

Press Release said...
July 25, 2018 12:53 ET | Source: Qu Biologics

VANCOUVER, British Columbia, July 25, 2018 (GLOBE NEWSWIRE) -- Qu Biologics Inc., a biopharmaceutical company developing Site Specific Immunomodulators (SSIs), a novel platform of immunotherapies designed to restore innate immune function, is pleased to announce that the first patient in the RESTORE Phase 2 clinical trial for patients with moderate to severe Crohn’s disease has been enrolled. The first stage of this trial is actively recruiting participants at sites in Vancouver BC, New Westminster BC and Hamilton ON.

Building on the results from Qu’s initial clinical trial in Crohn’s disease, the aim of this study is to further establish the safety and efficacy of the investigational drug QBECO SSI for the induction of clinical and endoscopic response and remission. QBECO SSI is intended to restore innate immune function and achieve sustained remission off all medications.

“Qu’s QBECO SSI is designed to correct the innate immune suppression that underlies Crohn’s disease, unlike current drugs that treat the end result of the disease by suppressing immune function,” stated Dr. Hal Gunn, MD, CEO Qu Biologics. “By restoring innate immune function, we are hopeful that our novel treatment approach may achieve long-term remission or cure off medications.”

Qu Biologics is recruiting a total of 20 adult Canadian residents with active moderate-to-severe Crohn’s disease for the open-label stage of the RESTORE trial. Every participant will receive QBECO SSI treatment for up to 52 weeks. The results from this stage of the study will inform a subsequent 150 patient randomized controlled trial which will recruit internationally.

For information about this Crohn’s disease clinical trial, visit www.restoretrial.ca and www.quibd.com.
For more information about Qu Biologics and the science behind SSIs, please visit www.qubiologics.com.

https://www.globenewswire.com/news-release/2018/07/25/1542108/0/en/qu-biologics-enrolls-the-first-patient-in-new-phase-2-crohn-s-disease-clinical-trial.html

These are four years old:

IamA CEO of Qu Biologics developing a new investigational treatment for Crohn's disease. AMA!

IamA CEO of Qu Biologics developing a new investigational treatment for Crohn's disease. AMA!

Qu Crohn's Trial Twitter page:

https://twitter.com/qucrohnstrial?lang=en

Qu Biologics’ Goal: Curing Crohn’s Disease by Restoring Innate Immunity

Presentation (video) by Dr. Hal Gunn - Berkeley Conference, 2018.

"Dr. Hal Gunn is the founder and CEO of Qu Biologics, and has dedicated his professional life to understanding how to optimally support the body’s immune response to chronic disease. Dr. Gunn is recognized both nationally and internationally as a leader in the field of supportive cancer care, and is the founder and past-CEO of InspireHealth, Canada’s leading supportive oncology centres. Dr. Gunn obtained his Doctorate of Medicine from the University of British Columbia and remains on faculty at UBC’s School of Medicine.

If you or someone you know is living with active Crohn’s disease which is not under control with current treatment, Qu Biologics is enrolling Canadian residents in a study to assess effectiveness of its novel Crohn’s disease therapy, QBECO Site Specific Immunomodulator (SSI). Rather than suppressing inflammation and immune function like current Crohn’s disease treatments, QBECO SSI is designed to boost and restore innate immune function. The study is open to Canadian residents with active Crohn’s disease. The treatment period is 1 year. By treating Crohn’s disease in this different way, QBECO SSI is designed to potentially achieve sustained remission off of medications and this study is designed to assess this. To learn more about QBECO and the study, please click on this link. https://www.quibd.com/"

https://humanpara.org/berkeley-conference-qu-biologics-goal-curing-crohns-disease-by-restoring-innate-immunity/

Hey everyone. I am new here just joined this forum today. Just want to give you heads up about qubiologics. I live in the US and was diagnosed about 4 years ago with Crohn's after receiving fistulatomy surgery and then a Colonoscopy. I have not gone on any medications as of yet and adhere strictly to SCD. Anyway I signed up for the study even though I live in the US and figured it is worth a shot. Well I was contacted by their head nurse for the trial telling me that the study was for Canadian residents only (which I knew) but the other thing she told me was that qubiologics will be having another trial in 2020 which will include the US and parts of Europe. She the asked if I wanted to be on a list for when that trial is closer to hopefully be included in that study. So I am attaching the email with her email address and if you want to be added to that list just email her directly. Hopefully this is the "cure" we've been waiting for God bless!

Here is the email:

Dear Jason,


Thank you for your interest in this study.

I am the registered nurse working with the Qu Biologics team on the Restore study.  My role is to be a contact and resource for people with Crohn’s disease who have questions about or are interested in participating in this study.  I will also be conducting pre-screening assessments for study eligibility via phone and will be available for on-going support for study enquirers and study participants.  At the moment, we are recruiting participants for our 20-patient study which is available in Canada through study sites in Vancouver BC, New Westminster BC and Hamilton ON.  

Thank you for completing the study web questionnaire.  To be eligible, participants must be residents of Canada so unfortunately we are not able to include you in this study.  Qu Biologics will be launching the second stage of this study in 2020 which will have more sites in Canada and some in USA and Europe.  If you like, I can add you to the contact list of those interested in finding out more about that study closer to the time.  Please let me know.

Please do not hesitate to contact me with any questions.


Thank you.


Best wishes,

Andrea


Andrea Cameron, RN MSc CCRP

Clinical Research Nurse

[email protected]

Thanks for the welcome. Also I emailed Andrea to see the timetable for when they hope to get this treatment to market and she said 5 to 7 years. (That's dissapointing) But hopefully the wait will be worth it for all of us.

Jonny_Murray said...


I wonder if, as times goes on and there is more and more evidence that this is a paradigm shifting treatment, there might be a argument for speeding up the process of getting it out there? Surely there must be a mechanism to have certain medications pushed through if its proven they can make the sort of difference this is likely to make.

This might be what you are looking for: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track

IIRC, there are a few people from the first trial who are still in remission, without taking the drug; but I might be wrong on that. Maybe someone else who remembers that better will reply here.

With the ongoing trial, we will have better answers for your questions.

Delta_hippo said...
People who understand the science better than me, would the hope be that if you got the trial drug (either first or after placebo) that would be enough to...no I won’t say the c word... make you better long term? Or is it something you have to stay on indefinitely? I.e. be well for a bit then 7 year wait for more?

One of the ways I stay sane is to tell myself just a bit longer then there will be a positive change for the better.

"We observed clinical remission during administration of the SSI QBECO in a compassionate-use context in seven of 10 patients who had moderate to severe clinical symptoms of active CD at baseline, with the remaining three of 10 noting improvement of their symptoms during treatment. Three of the 10 patients have experienced ongoing long-term remission."

" SSI QBECO was self-administered subcutaneously every second day, for a minimum of 2.5 months and a maximum of 11 months. All 10 patients reported improvement of symptoms while on the SSI QBECO treatment. Seven patients reported full resolution of clinical symptoms during a course of SSI QBECO of at least three months.Three patients have experienced ongoing sustained clinical remission after discontinuing all medications, including SSI treatment. The longest case of clinical remission is still ongoing (>4 years). "

Bressler, Brian et al. “Site-Specific Immunomodulator: A Novel Treatment for Crohn's Disease.” Gastroenterology research and practice vol. 2015 (2015): 231243. doi:10.1155/2015/231243

https://www.ncbi.nlm.nih.gov/pmc/articles/pmc4443884/

@73monte,

The above data I posted yesterday is not new, it's from their first Crohn's trial.

By the way, that article's "Discussion" section explains the proposed mechanism behind this therapy, if you or someone else are interested in learning it. I find it interesting.

QBECO SSI, published two days ago.

I find the results encouraging.

Post Edited (xy123) : 7/21/2019 7:02:30 PM (GMT-6)

Give it a thorough read when you have time; it's a well thought-out study. If you read the details, you might see that the results actually appear good. I find the results promising.

I think their next trial (which is currently recruiting patients) might show better results. This study's results show the vaccine might need longer duration of use to show a better efficacy rate. A trial with a larger population, longer treatment duration, endoscopic and histological evaluation; in addition to what they have looked for in this trial might show a more solid effect. This published study may not be really optimally designed to see the treatment's effects in its full capacity.

Apart from that, the study is well designed in my opinion, and judging from their article, they likely designed an even better study in terms of evaluating the efficacy for their currently recruiting Crohn's trial.

study article said...
The data from this trial will inform the design of larger definitive Phase II trials, which will include evaluation of endoscopic and histological endpoints, assessment of the impact of prior TNFα inhibitor exposure on QBECO response, evaluation of patients over a longer treatment period, microbiome assessment, and confirmation of the genetic and immune biomarker findings.

https://www.frontiersin.org/articles/10.3389/fmed.2019.00170/full

I don't keep my hopes too high, or support fanatically any future possible treatment option; but it's good to keep an eye on these kinds of studies that have a different focus than immunosuppression. Who knows, maybe we will get a cure (or a very good drug [low toxicity, high efficacy]) one day.