Study is FDA Prerequisite for Pivotal Registration Trial
Kalytera Therapeutics, Inc. (TSX VENTURE: KALY and OTCQB: KALTF) (the “Company” or “Kalytera”) today announced that it has initiated a food effect study (“Study KAL-07”), as part of its lead product development program evaluating cannabidiol (“CBD”) for the prevention of acute graft versus host disease (“GVHD”).
Study KAL-07 is being initiated pursuant to written guidance received from U.S. Food and Drug Administration (the “FDA”). The FDA is requiring that the Company complete a study in healthy volunteers to assess the effect of food intake on the absorption of oral CBD, prior to initiation of a Phase 3 registration study. The initiation of Study KAL-07 will satisfy this FDA requirement, and bring the Company’s program in prevention of acute GVHD another step closer to initiation of the pivotal registration study.
“Study KAL-07 is an important part of our overall Phase 2 program,” stated Robert Farrell, President and CEO of Kalytera. “Our goal is to complete all prerequisite work required by the FDA so that we can initiate registration testing as soon as possible. We anticipate that we will complete Study KAL-07 by the end of the second quarter this year.”
Kalytera’s Phase 2 program in prevention of GVHD consists of three separate clinical studies: (1) Study KAL-05; (2) Study KAL-07; and (3) Study KAL-08.
Study KAL-05 is the Company’s ongoing open label, multicenter study to evaluate multiple doses of CBD for the prevention of acute GVHD following allogeneic hematopoietic cell transplantation, commonly referred to as bone marrow transplantation. The study is evaluating the PK profile, safety, and efficacy of CBD at doses of 75, 150, and 300 mg twice daily (“BID”). It is anticipated that Study KAL-05 will be complete later this year, and will provide support for the planned Phase 3 registration study required for regulatory approval by the FDA.
Study KAL-07, the “food effect study”, is a double blind, randomized, two period, two treatment, fixed sequence, crossover (fed versus fasted) study to evaluate the effect of food on the pharmacokinetics of CBD, along with robust ECG monitoring in 32 healthy volunteers. This study is being conducted at a single site in Melbourne, Australia.
FDA guidelines also require that a proposed new drug be evaluated for its effects on cardiac rhythm. This evaluation is typically done in a separate study known as a QT or QTc study. To save time and expense, Kalytera is including a robust ECG evaluation of each subject enrolled in Study KAL-07. By including this evaluation in the design of Study KAL-07, the Company will be able to complete another critical study evaluation on the pathway to registration, without having to initiate a separate QT or QTc study for this purpose.
Study KAL-08, the “drug-drug interaction study”, is a second healthy volunteer study that has been requested by the FDA. This drug-drug interaction study will measure the effect of certain anti-fungal drugs upon metabolism of CBD, and the Company anticipates that it will complete Study KAL-08 during the third quarter this year. This study will also be conducted at a single site in Melbourne, Australia.
Patients receiving bone marrow transplants are at high risk of developing acute GVHD, a life-threatening complication that occurs when the transplanted donor cells attack the patient’s organs, including the skin, GI tract, liver, lungs, and eyes. It is estimated that up to 50% of patients who undergo a bone marrow transplant from a sibling donor, and up to 70% of patients who undergo a bone marrow transplant from an unrelated donor, will develop some level of GVHD. There are currently no FDA approved therapies for either the prevention or treatment of acute GVHD.
Kalytera’s Novel, Proprietary CBD Formulation for Prevention of GVHD
The CBD drug product that Kalytera is evaluating for prevention of GVHD is a novel and proprietary formulation designed to overcome issues of poor oral bioavailability and stability.
One of challenges seen in development of CBD as an orally administered pharmaceutical is the issue of poor oral bioavailability caused by first pass metabolism. First pass metabolism occurs when CBD is absorbed from the GI tract and is then delivered to the liver by the portal vein. A significant fraction of CBD is then metabolized in the liver before it reaches systemic circulation, thereby reducing the oral bioavailability of the drug.
To overcome this issue, Kalytera has developed a formulation of CBD that is intended to by-pass first pass liver metabolism. Kalytera’s formulation is designed to allow CBD to be absorbed directly into the circulatory system through the ileum intestine, without first passing through the liver, thereby greatly enhancing the oral bioavailability of this CBD formulation.
CBD is also known to be unstable, leading to drug degradation over time. Stability is a critical quality attribute directly linked to potency, purity and safety, and therefore it was important that Kalytera find a way to overcome the instability of CBD during storage. The company’s novel formulation is designed to overcome this important issue, and this has been successfully demonstrated in stability studies conducted by the Company.
CBD is a non-psychotropic ingredient of cannabis that does not cause euphoria or cognitive effects. Kalytera is the exclusive licensee of two issued U.S. patents covering the use of CBD in the prevention and treatment of GVHD, and is also the exclusive licensee of pending patent applications in other jurisdictions for the use of CBD in the prevention and treatment of GVHD.
Kalytera Therapeutics, Inc. is pioneering the development of CBD therapeutics. Through its proven leadership, drug development expertise, and intellectual property portfolio, Kalytera seeks to establish a leading position in the development of CBD medicines for a range of important unmet medical needs, with an initial focus on GVHD and treatment of acute and chronic pain.
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This press release may contain certain forward-looking information and statements (“forward- looking information”) within the meaning of applicable Canadian securities legislation, that are not based on historical fact, including without limitation in respect of its product candidate pipeline, planned clinical trials, regulatory approval prospects, intellectual property objectives and other statements containing the words “believes”, “anticipates”, “plans”, “intends”, “will”, “should”, “expects”, “continue”, “estimate”, “forecasts” and other similar expressions. Readers are cautioned to not place undue reliance on forward-looking information. Actual results and developments may differ materially from those contemplated by these statements depending on, among other things, the risk that future clinical studies may not proceed as expected or may produce unfavourable results. Kalytera undertakes no obligation to comment on analyses, expectations or statements made by third parties, its securities, or financial or operating results (as applicable). Although Kalytera believes that the expectations reflected in forward-looking information in this press release are reasonable, such forward-looking information has been based on expectations, factors and assumptions concerning future events which may prove to be inaccurate and are subject to numerous risks and uncertainties, certain of which are beyond Kalytera’s control. The forward-looking information contained in this press release is expressly qualified by this cautionary statement and is made as of the date hereof. Kalytera disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking information, whether as a result of new information, future events or otherwise.