Ingenew Pharma Announces the Completion of the Hesperidin Virtual Clinical Trial in COVID-19 Subjects

  • Proof-of-concept of a virtual Phase 2 double-blind placebo-controlled clinical trial
  • Hesperidin 1g daily reduced COVID-19 symptoms compared to placebo

Montreal, December 22, 2021. Ingenew Pharma announces it has completed a double-blind placebo-controlled clinical trial designed to evaluate the benefits of hesperidin therapy in symptomatic non-vaccinated COVID-19 subjects. The rationale and interest for using hesperidin in the treatment and even in the prevention of COVID-19 have been previously highlighted, both for its anti-oxidant and anti-inflammatory properties, and for its ability to block the entry and replication of SARS-CoV-2. 

In the trial, 216 subjects were randomized to receive either Hesperidin 1000 mg once-daily or placebo for 14 days. Thirteen symptoms including fever, cough, shortness of breath and anosmia (“Group A symptoms”) were monitored.Group A symptoms in the placebo vs hesperidin groups were 88.8% vs 88.5% at day 1 and reduced to 58.5 vs 49.4 % at day 14, respectively. At that timepoint, 15 subjects in the placebo group and 28 subjects in the hesperidin group failed to report their symptoms, which may be due to symptomatic improvement and decreased willingness to cooperate for the participants that felt better. No safety issues were observed in either cohort. If missing values are assumed to represent “no symptoms”, the hesperidin group shows a statistically significant reduction of 14.5 % of Group A symptoms from 50.9% to 36.4% (p = 0.03).  

The trial was conducted and coordinated by the Montreal Health Innovations Coordinating Center (MHICC) in a virtual mode, a patient-centred approach allowing patients to participate in clinical trials from the comfort of their own homes, facilitating recruitment, retention and follow-up of participants with digital tools.

“This clinical trial was successfully executed under challenging conditions imposed by the pandemic and is an early example illustrating the potential of virtual clinical trials that do not require in-person visits” stated Pierre Laurin president of Ingenew Pharma. “Scientists were able to monitor the effect of a potential treatment for COVID-19 without putting at risk the subjects and the healthcare professionals involved in the study”.

Dr Jocelyn Dupuis, principal investigator of the study, concluded: “These results are very encouraging when taking into account the attrition bias analysis and a best-case scenario where subjects with missing values have no symptom. We cannot exclude that hesperidin could have beneficial effects and further studies are encouraged including earlier treatment of longer duration and/or higher dosage.”

 

More about Ingenew Pharma

Ingenew Pharma is a biopharmaceutical company focused on addressing unmet medical needs and serving patients and families affected by serious and debilitating illness. Its primary therapeutic areas of interest include oncology and immunology. Ingenew’s current research and development efforts are evaluating proprietary preparations and delivery systems designed to improve the clinical efficacy and reduce toxicity and side effects associated with standard of care. At Ingenew Pharma, we leverage the extensive and successful track record of our scientists and apply adaptive-creative research and development principles to advance tangible and affordable medical solutions. (www.ingenewpharma.com) 

About the Montreal Health Innovations Coordinating Center (MHICC)

The Montreal Health Innovations Coordinating Center (MHICC) is a leading academic clinical research organization and an integral part of the Montreal Heart Institute. The MHICC possesses an established network of collaborators in over 4500 clinical sites in more than 30 countries. It has specific expertise in precision medicine, low-cost high-quality clinical trials, and drug repurposing. (www.mhicc.org)

Media Contacts:

Camille Turbide

[email protected]

+1-514-755-5354

Pierre Laurin

[email protected]

+1-833-460-8554

New Clinical Trial on Hesperidin

A natural product to fight symptoms related to COVID-19

The Montreal Heart Institute (MHI) is launching a new clinical trial to evaluate the effect of hesperidin on symptoms related to COVID-19. This flavonoid naturally found in citrus fruits has distinct properties that may reduce the entry and replication of the SARS-CoV2 virus in the body along with the modulation of inflammatory mediators, thus potentially reducing symptoms and prevent complications from the disease.

It was after evaluating the results of an exhaustive analysis carried out by scientists from the Quebec biotech firm Ingenew Pharma that Dr. Jocelyn Dupuis, Principal Investigator of the study, and his team decided to assess the potential of hesperidin against COVID-19, through a clinical study. “We have determined, by pharmacological simulation, a therapeutic dosage of hesperidin which will be administered in this study and which considerably exceeds an amount that could be absorbed during a normal diet rich in citrus fruits,” says Dr. Dupuis.

Based on studies that have already demonstrated the ability of hesperidin to reduce the level of key cytokines (proteins) involved in the inflammatory storm seen in severe cases of COVID-19, the researchers hypothesize that the antioxidant activities of hesperidin as well as its properties to modulate inflammation and prevent entry/replication of SARS-CoV-2 could also provide additional protection to patients infected with COVID-19 by reducing symptoms related to the disease and the need for medical assistance.

To participate in the study, the 216 candidates sought must:
• Be aged 18 and over, and have received a positive diagnosis of COVID-19 within the previous 48 hours;
• Have at least one symptom related to COVID-19;
• Not to be hospitalized;
• Be prepared to take hesperidin or placebo for 14 days;
• Have no problem with blood clotting; and
• Not have had surgery within 2 weeks of participation or have surgery planned within 2 weeks.

To participate or for more information about the Hesperidin Study, call 1-833-917-3369.

COVID-19 is causing a growing impact on the health network, delaying, among other things, the diagnosis and treatment of serious diseases such as cancer, along with numerous surgical interventions. In addition, a growing proportion of people with COVID-19 suffer from persistent residual symptoms responsible for absenteeism and general decrease in their overall quality of life. By reducing the symptoms and complications associated with COVID-19 as well as their duration, hesperidin could allow patients to return to normal more quickly, and consequently reduce the overload of the healthcare network.

The Hesperidin study (NCT04715932) is fully funded by the Montreal Heart Institute Foundation. The study product is supplied by Ingenew Pharma.

About Hesperidin
A recent and extensive search of the scientific literature going back to SARS-CoV (2002) found that a compound well known for its anti-inflammatory effects [1], hesperidin, was one of the few among hundreds of chemical entities to effectively inhibit chymotrypsin type 3 protease (3CLpro), a structure vital to SARS-CoV replication [2]. Hesperidin could also interfere with virus entry by blocking the binding between the SARS-CoV-2 spike (S) protein region binding domain and the angiotensin 2 converting enzyme (ACE2) on the surface of human cells [3]. This suggests that by interfering with or inhibiting 2 key proteins of SARS-CoV-2 necessary for entry and infection of cells, hesperidin could disrupt the rate of replication of the virus, allowing the infected subject to build up their natural immunity.

About the Montreal Heart Institute
Founded in 1954, the Montreal Heart Institute constantly strives for the highest standards of excellence in the cardiovascular field through its leadership in clinical and fundamental research, ultra-specialized care, professional training, and prevention. It is home to Canada’s largest cardiology research centre, cardiovascular prevention centre, and cardiovascular genetics centre. The Institute is affiliated with the Université de Montréal and has more than 2,000 employees, including 245 physicians and more than 85 researchers. icm-mhi.org

About Ingenew Pharma
Ingenew Pharma is a biopharmaceutical company focused on addressing unmet medical needs and serving patients and families affected by serious and debilitating illnesses. Its primary therapeutic areas of interest include oncology, neurology, and dermatology. Ingenew’s current research and development efforts are evaluating proprietary preparations and delivery systems designed to improve the clinical efficacy and reduce toxicity and side effects associated with standard of care. At Ingenew Pharma, we leverage the extensive and successful track record of our scientists and apply adaptive-creative research and development principles to advance tangible and affordable medical solutions. www.ingenewpharma.com

References:
1. Ding Z, Sun G, Zhu Z: Hesperidin attenuates influenza A virus (H1N1) induced lung injury in rats through its anti-inflammatory effect. Antivir Ther 2018, 23:611-615.
2. Lin CW, Tsai FJ, Tsai CH, Lai CC, Wan L, Ho TY, Hsieh CC, Chao PD: Anti-SARS coronavirus 3C-like protease effects of Isatis indigotica root and plant-derived phenolic compounds. Antiviral Res 2005, 68:36-42.
3. Wu C, Liu Y, Yang Y, Zhang P, Zhong W, Wang Y, Wang Q, Xu Y, Li M, Li X, et al: Analysis of therapeutic targets for SARS-CoV-2 and discovery of potential drugs by computational methods. Acta Pharmaceutica Sinica B 2020.

Ortho Regenerative Technologies Enters Into Licensing Agreement To Expand The Scope Of Its Technological Platform Applications

Montreal, QC, May 20, 2020 – Ortho Regenerative Technologies Inc. (CSE: ORTH) (“Ortho RTI” or the “Company”), an emerging orthobiologics company, today announced that it has entered into a strategic and licensing agreement (the “Agreement”) with Ingenew Pharmaceuticals Inc. (“Ingenew”). The Agreement will explore the expansion of the scope of Ortho’s proprietary technological platform applications to include the delivery of therapeutics.

Under the Agreement, Ingenew will fund the research and development activities looking to specifically further advance Ortho RTI’s proprietary technology platform as a delivery system for its proprietary therapeutics. Ingenew plans to integrate Ortho RTI’s platform in its ongoing various oncology, urology and periodontal diseases programs, which are the main therapeutic areas that are exclusive to Ingenew under the Agreement. Ortho RTI is entitled to royalties on sales of products and on licensing revenues integrating Ingenew therapeutics agents and Ortho RTI’s proprietary delivery platform. Ortho RTI will also benefit from a fully paid up grant back license from Ingenew to access all improvements to its proprietary technology platform for orthopedic applications. Other therapeutic fields can be targeted leveraging the further advanced Ortho RTI platform developed by either party or in collaboration.

“This agreement further validates the value and the scope of potential applications that can be derived from using our proprietary technological platform”, said Claude LeDuc, President and Chief Executive Officer of Ortho RTI. “The addition of therapeutic delivery applications is just one of the avenues we are currently investigating to maximize the value we can generate from our technology. It will also serve to offset some of our ongoing costs as we remain dedicated to the development of our core orthopedic interests. It is part of our business plan to explore such opportunities to create additional value for all our shareholders”.

Mr. Pierre Laurin, President and Chief Executive Officer of Ingenew, commented: “We are very impressed by the performance of Ortho’s platform technology as it gets ready to initiate its clinical program. It sets the stage for this unique win-win strategic collaboration where Ingenew gets to further advance Ortho’s technology by developing state-of-the-art and optimized delivery systems for its own therapeutics, which in turn can be leveraged by Ortho for its orthopedic program and for additional applications. As more applications are successfully developed and commercialized, more value is created for all parties involved”.

About Ingenew Pharmaceuticals Inc.

Ingenew Pharma is a biopharmaceutical company focused on addressing unmet medical needs and serving patients and families affected by serious and debilitating illness. Its primary therapeutic areas of interest include oncology, neurology, urology and dermatology. Ingenew’s current research and development efforts are evaluating proprietary preparations and delivery systems designed to improve the clinical efficacy and reduce toxicity and side effects associated with standard of care. At Ingenew Pharma, we leverage the extensive and successful track record of our scientists and apply adaptive-creative research & development principles to advance tangible and affordable medical solutions. Ingenew Pharma’s website further describing its corporate mission and activities is expected to come online in June. (www.ingenewpharma.com)

About Ortho Regenerative Technologies Inc.

Ortho RTI is an emerging orthobiologics company dedicated to the development of novel therapeutic soft tissue repair technologies to dramatically improve the success rate of orthopedic and sports medicine surgeries. Our proprietary RESTORE technology platform, is a muco-adhesive CHITOSAN based biopolymer matrix, specifically designed to deliver biologics such as Platelet-Rich Plasma (PRP) or Bone Marrow Aspirate Concentrate (BMAC), to augment and guide the regeneration of new tissue in various musculoskeletal conditions. Ortho-R, our lead Chitosan-PRP hybrid biologic implant product, is formulated and designed to increase the healing rates of occupational and sports related injuries to tendons, meniscus and ligaments. Other formulations are being developed for cartilage repair, bone void filling and osteoarthritis treatment. The ChitosanPRP combination ORTHO-R implant can be directly applied into the site of injury by a surgeon during a routine operative procedure without significantly extending the time of the surgery and without further intervention. An Ortho-R Rotator Cuff Tear Repair US pilot clinical trial is being prepared and coordinated. Parallelly, an IDE FDA submission is planned for Q2 2020. Considering the significant potential of our technology platform, Ortho RTI continues to assess new therapeutic target uses outside of the soft tissue repair field. Further information about Ortho RTI is available on the Company’s website at www.orthorti.com and on SEDAR at www.sedar.com. Also follow us on LinkedIn and Twitter.

This news release may contain certain forward-looking statements regarding the Company’s expectations for future events. Such expectations are based on certain assumptions that are founded on currently available information. If these assumptions prove incorrect, actual results may differ materially from those contemplated by the forward-looking statements contained in this press release. Factors that could cause actual results to differ include, amongst others, uncertainty as to the final result and other risks. The Company disclaims any intention or obligation to publicly update or revise any forward- looking statements, whether as a result of new information, future events or otherwise, other than as required by security laws.

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATIONS SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

For further Information, please contact:

Claude LeDuc,
President and Chief Executive Officer
(514) 693-8804
[email protected]

or

Frederic Dumais,
Director Communications and Investor Relations
(514) 782-8803
[email protected]