New Active Medicinal
Substance for Substantial
Unmet Medical Needs
THE FUNCTION OF
… and Reduces
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Replicon Health Oy has developed a New Active Medicinal Substance (NAS/NCE) that can activate energy metabolism and mitochondria in humans and in animals without an increase in oxidative stress. After years of successful pretesting, we have now shown in a peer reviewed human study that well tolerated oral doses reduces low grade inflammation already in 4-days in aging persons, and further that in 3-weeks substantial improvements for certain Block Buster drug indications with unmet medical need can be seen. Especially the immune system, CNS, muscles, and the liver function benefit. NASH / NAFLD and related orphan drug indications are our primary therapeutic target areas.
Our patented molecule formulation can uniquely influence the causes of many age-associated disorders, not just alleviate the symptoms. Well tolerated mechanism of action is based on several whole-body enhancements of mitochondrial energy metabolism creating fast, strong, and sustained efficacy.
We aim to enter the markets with partners and carefully selected oral solutions. Developed commercially viable mass production technology is sustainable.
20.2.2023 Replicon Health initiates a confirmatory preclinical study in NAFLD. The outsourced study contains positive and negative controls. Results should be ready latest in June 2023, if all goes well.
15.11.2022 Peer reviewed article on Hepatic Activation and Reduction of Inflammation in Humans after oral DGA regimen has been accepted for publication.
16.8.2022 European Patent Office has decided to grant Replicon Health a patent for the treatment of degeneration diseases related to aging
10.8.2022 Second peer reviewed scientific article on mitochondrial activation in humans has been accepted into further review before publication
2.2.2022 Replicon Health receives an additional US-patent for RH013001 / DGA covering the whole spectrum of mitochondrial activation in health and in disease.
29.10.2021 Peer Reviewed Scientific Article on Mitochondrial Activation in Humans Published. There will be several follow-up articles because all relevant core material could not be included in a single article. Potential Block Buster applications with unmet medical need can be identified.
21.9.2021 New scientific article was accepted for publication. The manuscript was submitted on 3rd of August.
3.7.2021 Two primary markers received in June 2021 (see below news) confirm earlier solid findings. Those results will be added to relevant scientific publication after the summer break.
22.6.2021 Some important confirmatory biomarkers from our randomized clinical trial (12/2019) were finally received. Corona virus restrictions delayed them by more than 12 months.
19.1.2021 Double Blinded Trial with Healthy Volunteers Registered into ClinicalTrials.gov. “Novel Energy Metabolic Signaling Molecule with Therapeutic Potential”
19.10.2020 Scientific ”breakthrough” article related to human study is ready for submission, first reviewer comments received.
5.6.2020 Replicon’s RH013001 compound initiates 5-week LCR and HCR rat study with a 0-control and a positive control. Effect on aerobic capacity, body weigh and organs, and selected blood markers will be investigated.
9.4.2020 Replicon Health is temporarily fully committed in developing a drug that reduces the burden of hospital intensive care units due to viral pandemics like COVID-19. Substance has already been successfully tested in healthy humans. Targeted therapy covers the therapy area that we selected based on clinical trial 10-11/2019 but is much wider, now it covers all organs.
18.3.2020 Current pandemic crises causes an amendment to the side indications that Replicon will investigate in early clinical trials. Confidential selection of the main indication remains the same (see below). Long way to go but planning has been already started.
15.1.2020 Combining earlier human tissue data with received new data from living humans pave way for the selection of our focus Block Buster -indication with unmet medical need. Only now we possess adequate set of data and certainty for this crucial selection. Based on our several independent and verified human results RH013001 will extremely likely be able to address selected unmet medical need and enter the market in roughly 5-7 years from now. Benefit for the patients will be significant.
Global annual sales of the focus Block Buster -indication is some USD 10 bn, currently mostly off-label sales. It is expected to increase rapidly when new drugs get approvals. According to some market forecasts sales will soar to USD 40 billion by the year 2028. Our plan is to out-license first indication to some bigger pharma company after phase 2 tests.
8.1.2020 During early 2020 mRNA expressions at whole genome level will be analysed as well as certain pre-selected cytokines and other confirmatory markers. Already before these final analyses Replicon Health has gained enormously valuable clinical set of data from its patented therapeutic molecule. Benefits for the patients can be and cost savings for the health sector will be substantial.
12/2019 Supplementary results from the clinical trial confirm reduction of low-grade inflammation in apparently healthy older persons. Multiple shifts in energy metabolism enable surprisingly rapid adaptation of the immune system towards pathological and other threats.
11/2019 Preliminary results of the placebo controlled clinical study are very promising. Main therapeutic targets were reached, and the mechanism of action was re-confirmed.
09/2019 Recruiting of the study subjects has been completed. Experimental phase of the clinical study will start in October and last until November 2019.
07/2019 Major US patent granted for Replicon Health.
05/2019 Annual shareholder meeting on the 7th of May authorized two financing rounds. First, currently on-going share issue of up to 400 000 euro closes at the end of August 2019. The main share issue of up to 2-3 M€ for venture capitalist and other professionals will materialize later.
05/2019 Replicon receives an approval for a clinical study with healthy volunteers from Ethical Committee of a Central Hospital (KSSHP). Enhancement of aerobic energy metabolism and its positive effect towards inflammation in humans is the main interest of the study from Official Health Claim and commercialization point of view.
02/2019 Experienced mitochondria researchers have obtained strong positive results on the efficacy of RH activators in enhancement of mitochondrial energy metabolism in whole organisms in their normal environment. Doses for the study were instructed by Replicon Health. These otherwise totally independent in vivo results have been verified by repetition of the test.
12/2018 New in vitro study on reactive oxygen species (ROS) by independent university researchers confirm that ROS scavenging by RH activators is more substantial towards mitochondrial ROS compared to cytosolic ROS. This is perfectly in line with the mechanism of action of RH activators.
09/2018 Confirmatory knowledge on health benefitting mitochondrial signalling revealed by GC-MS measurements.
08/2018 IPRs moving successfully in selected major market areas
07/2018 Replicon receives the major part of the R&D financing granted in 06/2017 by Business Finland (see below)
05/2018 Small bridge financing from current owners completed (at par value compared to previous round)
04/2018 Successful production related R&D project completed.
03/2018 Tissue / cell level protection against a specific viral infection shown in an in vitro study. (More influential / relevant systemic efficacy against viral infections indicated earlier in several in vivo studies.)
01/2018 New in vitro study confirms the activation of mitochondrial energy metabolism by RH activators in a new tissue type. The study was conducted by an independent university research group who used different analyzing technology compared to previous in vitro and in vivo studies with similar, fully consistent findings.
09/2017 Replicon Health moves to new bigger premises in Otaniemi, Espoo to facilitate smooth ramp up for commercialization of first prooducts.
06/2017 Replicon Health receives R&D financing from TEKES, Finnish Funding Agency for Innovation.
05/2017 Experimental challenge study with pathogenic gram-negative bacteria gave notably good and statistically very significant outcome compared to placebo. However, the experimental study set up had to be slightly modified during the study thus deteriorating scientific impact. Nevertheless, practical economic results were even better than expected.
03/2017 Confirmatory double controlled challenge study has reached its main end points. Conducted two latest efficacy studies now confirm that RH -activators can replace antimicrobial agents in practical applications. Both studies were conducted by independent experts and relevant efficacy results deviate statistically significantly from 0-control (placebo group) in both. Additionally, the test set-up was demanding in respect to revealing the efficacy of RH activators in both studies.
01/2017 Double controlled protozoal challenge study conducted in Oct – Nov 2016 has reached its primary end points. Additionally dose responses were consistent in the study thus confirming positive results. Second test has already been initiated.
01/2016 Replicon Health has filed two additional patent applications related to its invention thus extending the already massive coverage of the IPRs and furthermore confirming the proof of concept of the main invention.