MedTrace Pharma announces IND approval with the initiation of RAPID-WATER phase 3 clinical trial
MedTrace Pharma A/S announced today the FDA approval of the company’s Investigational New Drug (IND) application and the approval to commence the RAPID-WATER clinical trial to evaluate the use of 15O-water PET in diagnosing Coronary Artery Disease (CAD). The global trial will enroll adults with suspected CAD.
For more information on the 15O-water RAPID-WATER clinical trial, visit: Radiolabeled Perfusion to Identify Coronary Artery Disease Using Water To Evaluate Responses of Myocardial Flow – Full-Text View – ClinicalTrials.gov
According to statistics from the American Heart Association, Heart Disease remains the no. 1 cause of death in the United States: Coronary Heart Disease (CHD) accounted for approximately 12.6% of deaths in the United States in 2018, causing 360,900 deaths.
Approximately every 40 seconds, someone in the United States will have a myocardial infarction, and the estimated direct and indirect cost of heart disease from 2017 to 2018 (average annual) was $228.7 billion in the United States1.
The leading cause of CHD is Coronary Artery Disease (CAD) which is the slow build-up of plaque in the coronary arteries, which can eventually lead to heart attack due to constriction of blood flow to the heart muscle.
“Having the means to effectively diagnose CAD with high accuracy and further quantify the progression of disease is a top priority in all developed healthcare systems given the sheer societal impact”, says Rune Wiik Kristensen, COO of MedTrace Pharma A/S.
“If successful, 15O-water PET could provide an important new diagnostic platform for evaluating CAD. We hope that the platform will save lives through earlier disease detection and lead to better disease management”, Rune Wiik Kristensen says.
The company announces that the trial is fully funded, the first trial sites are already identified, and enrollment is expected to commence in Q2 2022 and continue for 12 months.
MedTrace intends to further stimulate investigator-initiated trials in the US for other indications than CAD, by accommodating their desires to reference the MedTrace approved IND and use the technology in expanded research. Similar measures are being taken in the EU.
“The mission of MedTrace is to spread the clinical utility of 15O-water PET into additional disease areas. To achieve this goal, we strive to develop strong research partnerships with clinicians with great ideas about where 15O-water may play a role. We see it as a platform technology as perfusion plays a role in a multitude of different diseases, rendering the market potential very high” says CEO Martin Stenfeldt, MedTrace Pharma A/S.
About the RAPID-WATER Trial
The trial is a Phase 3, prospective, open-label, multicenter study of [15-O]-H2O injection for PET imaging of subjects with suspected CAD. Approximately 182 evaluable participants with suspected CAD referred for noninvasive stress testing will be included in the study at approximately 10 study sites in the United States and Europe. Approximately 215 participants will be enrolled in total to account for an estimated 15% drop-out rate. Screening assessments will occur between -21 and 0 days prior to enrollment to confirm eligibility. All participants will receive two doses of [15-O]-H2O as part of a single PET imaging session (one dose at rest and one during pharmacological stress with adenosine).
The Phase 3 trial has been long anticipated with excitement as described by the Principal Investigator Marcelo Di Carli, Brigham & Women’s Hospital, Boston, MA, USA:
“As Principal Investigator of the RAPID-WATER study, I am thrilled by the news that the FDA has issued a ‘may proceed’ letter for the study sponsored by MedTrace. The multicenter, international RAPID-WATER study seeks to test the clinical effectiveness and safety of 15O-water and MedTrace’s unique automated production system as a clinical myocardial perfusion imaging agent to be used with Positron Emission Tomography in the United States. Cardiac PET is a powerful non-invasive imaging test to diagnose coronary artery disease and the addition of 15O-water will expand the list of imaging agents available for clinical use. I look forward to starting this exciting study”, Marcelo Di Carli says.
About radioactive water:
Radioactive water (15O-water) is a radiopharmaceutical generated by the conversion of oxygen-15 gas from a cyclotron into water. The process requires the addition of hydrogen gas and heat. The half-life of Oxygen-15 is 122 seconds, making it challenging to scale the use of the tracer in clinical routine. However, the short half-life also significantly reduces the scan time of the patient as well as the radioactive dose compared to conventional radiopharmaceuticals for the same indication. The scientific community generally recognizes radioactive water as the ideal perfusion and blood flow tracer as it is chemically identical to water which is the main constituent of blood.
MedTrace has automated the production and administration of the radioactive tracer and will be using the automated solution in the RAPID-WATER clinical trial.
About MedTrace Pharma A/S
Headquartered in Copenhagen, Denmark, MedTrace Pharma A/S was founded in 2015 by Martin Stenfeldt, Rune Wiik Kristensen and Peter Larsen. In 2018 MedTrace merged with the software company aQuant founded by Jens Soerensen, Hans Haarms, Mark Lubberink, and Lars Toldbod that had developed a unique analytic software platform specifically for radioactive water. The company today is a privately held pharmaceutical company focused on PET imaging technologies with a particular emphasis on blood flow and perfusion quantification. The company has a late-stage pipeline including 15O-water as a radiopharmaceutical and aQuant as a medical device software (under development) for the image analysis and quantification of blood flow and perfusion data from cardiac PET scans. In addition to the described trial, the company is pursuing regulatory certification in the EU.
Amongst the company’s key shareholders are The Danish pension fund ATP, SwissCanto Private Equity Invest, The European Innovation Council and BankInvest. The team at MedTrace are committed to bringing 15O-water PET into clinical routine and to explore the potential in other disease areas such as oncology and neurology.
Company website: https://medtrace.dk/
Forward looking statement
This news release by MedTrace Pharma A/S (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. The company offers no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
- Tsao CW, Aday AW, Almarzooq ZI, Alonso A, Beaton AZ, BittencourtMS, Boehme AK, Buxton AE, Carson AP, CommodoreMensah Y, Elkind MSV, Evenson KR, Eze-Nliam C, Ferguson JF, Generoso G, Ho JE, Kalani R, Khan SS, Kissela BM, Knutson KL, Levine DA, Lewis TT, Liu J, Loop MS, Ma J, Mussolino ME, Navaneethan SD, Perak AM, Poudel R, Rezk-Hanna M, Roth GA, Schroeder EB, Shah SH, Thacker EL, VanWagner LB, Virani SS, Voecks JH, Wang N-Y, Yaffe K, Martin SS; on behalf of the American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2022 update: a report from the American Heart Association [published online ahead of print Wednesday, January 26, 2022]. doi: 10.1161/CIR.0000000000001052
Rune Wiik Kristensen
Phone +45 31367080