Kalytera Therapeutics, Inc., a pharmaceutical company developing a portfolio of non-psychoactive cannabinoid (“CBD”) and synthetic CBD medicines that address the unmet needs of large patient populations, and Ramot at Tel Aviv University (“Ramot”) (“TAU”), today announced they have signed a research service agreement to assess the therapeutic potential of Kalytera drug candidates KAL671 and KAL436 in bone fracture healing.
Ramot is TAU’s technology transfer company. Under the terms of the agreement, the Companies will develop, conduct and publish a series of scientifically controlled, pre-clinical research studies beginning in the fourth quarter of 2015 extending through the end of 2016. Kalytera exclusively licensed KAL671 and KAL436, in February 2015, from Yissum Research Development Company with multiple pre-clinical studies on these two compounds currently underway or planned.
The research collaboration with Ramot will be led by Yankel Gabet, D.M.D., Ph.D., the Director of the Bone Research Laboratory at the Sackler Faculty of Medicine, Tel Aviv University and a member of the Kalytera Scientific Advisory Board. Dr. Gabet is widely known for his research in bone fractures, bone healing, and bone loss. In a study published in March 2015, Dr. Gabet reported that cannabidiol (“CBD”), a key non-psychoactive cannabis constituent, enhanced the biomechanical properties of healing midfemoral fractures in rat studies.
“The testing of KAL436, a synthetic form of CBD, and KAL671, a form of the free fatty acid oleoyl-alphamethyl-serine, will seek to replicate the results of our prior studies in rats with small molecules which are cannabinoid-like but not cannabis plant derived,” said Dr. Gabet. “This is intended to enable the development of commercially viable drug candidates with improved drug specificity and a lower side effect profile. With millions of people suffering bone fractures, and hundreds of millions more with osteoporosis, we are excited to collaborate with Kalytera on this important, potentially ground-breaking research.”
Bone fractures can result from high force impact, stress or from medical conditions that weaken the bones such as osteoporosis. In the United States alone, osteoporosis affects approximately 10.2 million adults while another 43.4 million have low bone mass, thus more than one-half of the total U.S. adult population is currently affected. For women, the rate of bone fractures associated with osteoporosis is higher than the occurrence of heart attack, stroke, and breast cancer combined.
“Bone remodeling is a lifelong process that regulates the gain and loss of bone in adults,” said Raphael Mechoulam, Ph.D., Chair of Kalytera’s Scientific Advisory Board. “It also plays a determinant role in fracture healing. KAL671 is a previously unexplored lipid regulator of bone remodeling that may represent an important new type of anti-osteoporotic drug and accelerate fracture healing. The studies at Ramot, in concert with ongoing studies with our other research partners, will help explore the potential of these novel drug candidates.”
About Ramot at Tel Aviv University
Ramot is the technology transfer company of Tel Aviv University. Ramot fosters, initiates, leads, and manages the transfer of new technologies from university laboratories to the marketplace by performing all activities relating to the protection and commercialization of inventions and discoveries made by faculty, students, and other researchers. Ramot provides a dynamic interface connecting industry to leading-edge science and innovation, offering new business opportunities in a broad range of emerging markets. For more information, visit: www.ramot.org.
Kalytera Therapeutics, Inc. is a pharmaceutical company that is developing a portfolio of nonpsychoactive cannabinoid and cannabinoid-modulating medicines that address the unmet needs of large patient populations. The Company seeks to commercialize its proprietary, synthetic cannabinoid therapies across a range of disease states, with an initial focus on bone healing and osteoporosis. For more information, visit: https://kalytera.co/.
This press release contains certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding the efficacy of potential products, the timelines for bringing such products to market, and the availability of funding sources for continued development of such products. Forward-looking statements are based on management’s estimates, assumptions, and projections, and are subject to uncertainties, many of which are beyond the control of Kalytera. Actual results may differ materially from those anticipated in any forward-looking statement. Factors that may cause such differences include the risks that potential products that appear promising to Kalytera cannot be shown to be efficacious or safe in subsequent preclinical or clinical trials, Kalytera will not obtain appropriate or necessary governmental approvals to market these or other potential products, Kalytera may not be able to obtain anticipated funding for its development projects or other needed funding, and Kalytera may not be able to secure or enforce adequate legal protection, including patent protection, for its products. All forward-looking statements included in this press release are made only as of the date of this press release, and Kalytera does not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.