On June 5, 2018 Artelo Biosciences, Inc. (OTCQB: ARTL), a biopharmaceutical company focused on the development of therapeutic treatments that modulate the endocannabinoid system, reported that it has entered into a global research and development partnership with Syngene International Ltd (Press release, Aptus Clinical, JUN 5, 2018, View Source [SID1234527281]). (Syngene), an India-based integrated discovery-development service provider, through its wholly-owned subsidiary, Trinity Research and Development Limited, and Aptus Clinical Ltd. (Aptus), a specialist UK-based Clinical Contract Research Organization with particular expertise in oncology, rare diseases and advanced therapies. The partnership will focus on supporting the drug discovery and clinical development of ART27.13, Artelo’s Phase 2 ready, high-potency dual cannabinoid agonist, in oncology.
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"ART27.13 represents an important new therapeutic class of anti-cancer medicine. While a lot is already known about the drug’s pre-clinical and clinical profile, we believe working alongside proven global talent will ensure that our new insights into ART27.13 are rapidly transitioned into the clinic," said Andrew Yates, PhD, ART27.13 Program Leader. "This partnership is a premier example of how global partners with a common interest can be harnessed inside the exciting R&D environment in the United Kingdom."
As part of the agreement, Syngene will be the discovery and development partner providing a pre-clinical data package to support the advancement of ART27.13 for anti-cancer indications. Aptus Clinical will develop and design an anti-cancer clinical study that is scientifically credible, ethically acceptable and operationally deliverable. It will also provide clinical development and regulatory expertise to the partnership. Previously, Artelo established a UK subsidiary at the Alderley Park BioHub in Cheshire, where Dr. Yates directs the ART27.13 program.
"It is an honor to be a part of such an innovative delivery model that globally integrates the best in drug discovery and clinical development expertise to support Artelo in its efforts to develop future novel oncology drugs for the benefit of patients," stated Steve McConchie, CEO of Aptus Clinical.
Dr. Manoj Nerurkar, Chief Operating Officer, Syngene International added, "We are happy to partner with Artelo in developing ART27.13 for anti-cancer indications. Oncology is one of the focus areas for Syngene and this global partnership will help us harness our individual expertise to develop a better product for the benefit of cancer patients worldwide."
About ART27.13
ART27.13 is a clinic-ready, potent, peripherally restricted CB1/CB2 synthetic agonist. Existing clinical data with ART27.13 suggests meaningful potential for the treatment of cancer-related anorexia and weight loss (cachexia). In five Phase I clinical studies including over 200 subjects, ART27.13 demonstrated a statistically significant and dose-proportional increase in body weight. In ongoing consultation with regulatory authorities, Artelo plans to advance ART27.13 as a multi-modal supportive care therapy for cancer patients suffering from anorexia or weight loss. In addition to its potential for cancer related anorexia, ART27.13 may also have direct anti-tumor activity. Numerous non-peripherally restricted CB1 and CB2 agonists have shown promising results as anti-tumor drugs, yet their profile made them unsuitable for further development. Because ART27.13 is peripherally restricted, Artelo is investigating the dual agonist for its anti-cancer potential. ART27.13 is under a global option and license agreement from the NEOMED Institute (Montreal, Canada) and with whom Artelo is also collaborating on the clinical development of ART27.13.