Jupiter Orphan Therapeutics Announces First Patient Dosed in Phase I Dose Escalation Study of JOTROL™
JUPITER, Fla., Jan. 11, 2021 /PRNewswire/ -- Jupiter Orphan Therapeutics Inc. ("JOT") a biotechnology company pioneering a novel and disease modifying product named JOTROL™, today announced that the first patient has been dosed in a Phase I dose escalation study of JOTROL™. The Phase I is conducted with healthy volunteers in various ages and include a food effect arm. Per protocol, the first patient cohort has been dosed and the study is continuing in January and February of 2021. Top line data is expected to be available in March 2021. The initial dose appear well-tolerated as the escalation continues toward clinically relevant doses. JOTROL™ is, through its unique bioavailability, the first and only resveratrol product that can deliver a therapeutically effective dose without causing any severe gastro-intestinal side effects. JOTROL™ is a platform product that is expected to be an effective treatment in many rare diseases such as ataxias, lysosomal storage disorders and mitochondrial diseases. Building on the positive scientific review and funding from NIA JOT is also in preparation of a Phase II trial for treatment of Mild Cognitive Impairment (MCI).
"We have been able to move the Phase I trial forward very quickly after we received funding from the NIA, $1.76 M, and equity investors, $1.2 M, by setting up clinical material manufacturing through Catalent Pharma Solutions and contracting with Syneos Health Phase I unit in Miami, Florida. We are assuming positive Phase I results, which will be a Proof Of Concept of our product and have started preparations for Phase II trials in MPS-1, Friedreich's ataxia and MELAS in addition to MCI study preparation. We have presently cash covering us through 2021 and are targeting additional financing through an equity raise, possible partnering as well as utilizing non-dilutive funding sources to be able to start several Phase II trials later in 2021," stated Christer Rosén, Chairman and CEO.
"I am very pleased with our progress and excited to be designing efficacy trials in several diseases. Key benefits of a platform product like JOTROL™ is that the Phase I trial results can be cross-referenced for any Phase II trials involving JOTROL™ contributing to a very fast and cost-effective way of achieving Phase II study results. There are already human trials executed with nutritional grade resveratrol in several diseases that have shown benefits, although with GI tolerability issues, that gives us confidence for successful outcomes in multiple diseases. With financing in place, we may have positive clinical results already by mid 2022," stated Marshall Hayward, CSO.
For more information about Jupiter Orphan Therapeutics and JOTROLTM, visit www.jupiterorphan.com.
Jupiter Orphan Therapeutics, Inc. | 601 Heritage Drive | Jupiter, FL 33458
SOURCE Jupiter Orphan Therapeutics, Inc.