Ceapro Inc. Reports Preliminary Results from Clinical Trial Evaluating Oat Beta Glucan in Patients with High Cholesterol Levels

Rhea-AI Summary

Ceapro Inc. (TSX-V: CZO; OTCQX: CRPOF) reported preliminary results from a clinical trial assessing the efficacy and safety of oat beta glucan for hyperlipidemia. The trial, involving 263 patients, aimed to compare three dosages of beta glucan against a placebo. While the primary endpoint related to LDL-C did not yield statistically significant results, some positive trends were noted in weight and body-mass index changes, albeit without statistical significance. The product meets market authorization requirements, indicating potential future benefits from continued research.

Positive

• Oat beta glucan well tolerated with no reported deaths.
• Study conducted under best clinical practices by the Montreal Heart Institute.
• Compliance with study pill intake was over 80%.

Negative

• Primary endpoint of LDL-C change was not statistically significant.
• Weight and body-mass index changes did not reach statistical significance.

EDMONTON, Alberta, Nov. 17, 2021 (GLOBE NEWSWIRE) -- Ceapro Inc. (TSX-V: CZO; OTCQX: CRPOF) (“Ceapro” or the “Company”), a growth-stage biotechnology company focused on the development and commercialization of active ingredients for healthcare and cosmetic industries, today reported preliminary results from the clinical study entitled “A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Compare the Efficacy and Safety of High-Medium Molecular Weight Beta-Glucan as Add-On to Statin Therapy in Subjects with Hyperlipidemia”. Following a protocol amendment, patients not treated with a statin were also eligible to enter the study.  

This clinical trial assessed the safety and efficacy of three dosages of oat beta glucan administered as 500 mg pills (1.5 g, 3 g and 6 g per day) compared to placebo. A total of 263 patients (169 females and 94 males) were enrolled in the study. The majority of patients did not receive a statin. The overall compliance to study pill intake was greater than 80%. From a safety perspective, there was no death and beta glucan was generally well tolerated.

The effect of oat beta glucan on the study primary endpoint of change in low-density lipoprotein cholesterol (LDL-C) was not statistically significant compared to placebo. Of note, amongst some positive findings observed with different parameters, there were dosage-related responses in weight and body-mass index at 12 weeks, but they also did not reach statistical significance.

“While we had hoped for a more definitive statistically significant outcome, many observations send some positive signals. They are in accordance with recent data by Cicero et al.¹ on another beta glucan nutraceutical formulation and reinforce the hypothesis that oat beta glucan may offer appreciable health benefits, as indicated in Health Canada’s oat beta glucan approved monograph. While Ceapro’s oat beta glucan product complies with requirements for market authorization for a natural product and seeks to surpass marketed products, continued efforts may be warranted to explore its effect on weight and body-mass index with prolonged exposure and possibly higher dosage. The current study has been conducted under best clinical research practices by the expert team of the Montreal Heart Institute. I am very grateful for their great work, resilience, professionalism and competencies during this pandemic period,” commented Gilles R. Gagnon, Chief Executive Officer of Ceapro.

About Ceapro Inc.

Ceapro Inc. is a Canadian biotechnology company involved in the development of proprietary extraction technology and the application of this technology to the production of extracts and “active ingredients” from oats and other renewable plant resources. Ceapro adds further value to its extracts by supporting their use in cosmeceutical, nutraceutical, and therapeutics products for humans and animals. The Company has a broad range of expertise in natural product chemistry, microbiology, biochemistry, immunology and process engineering. These skills merge in the fields of active ingredients, biopharmaceuticals and drug-delivery solutions. For more information on Ceapro, please visit the Company’s website at www.ceapro.com.

For more information contact:

Jenene Thomas
JTC Team, LLC
Investor Relations and Corporate Communications Advisor
T (US): +1 (833) 475-8247
E: czo@jtcir.com

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release

¹ Arrigo F. G. Cicero et al., « A Randomized Placebo-Controlled Clinical Trial to Evaluate the Medium-Term Effects of Oat Fibers on Human Health: The Beta-Glucan Effects on Lipid Profile, Glycemia and InTestinal Health (BELT) Study », Nutrients 12, n^o 3 (3 mars 2020): E686, https://doi.org/10.3390/nu12030686.

 

FAQ

What were the results of Ceapro's clinical trial for oat beta glucan?

The clinical trial reported that the primary endpoint of LDL-C change was not statistically significant, but some dosage-related responses in weight and body-mass index were observed.

How many patients participated in the Ceapro clinical trial?

263 patients participated in the clinical trial.

What were the dosages of oat beta glucan used in the study?

The dosages tested were 1.5 g, 3 g, and 6 g per day.

What is the next step for Ceapro after this clinical trial?

Ceapro may explore prolonged exposure and potentially higher dosages of oat beta glucan to further assess its efficacy.

Did the study meet safety standards?

Yes, the study was conducted under strict clinical research practices and beta glucan was generally well tolerated.