iX Biopharma Announces Development Of Supplement For Jet Lag
• First supplement in the Group’s product pipeline
• Lower cost of development and shorter time-to-market compared to pharmaceutical products
Singapore, 17 August 2016 – Homegrown specialty pharmaceutical company iX Biopharma Ltd. (“iX Biopharma” or, together with its subsidiaries, “the Group”) has completed pre-clinical development for WafeRest, a sublingual melatonin wafer supplement aimed to alleviate jet lag and improve sleep quality.
Melatonin is a hormone produced in the brain that regulates the circadian rhythm (sleep-wake cycle) and people’s ability to sleep. Research has shown that melatonin has a low absolute bioavailability either due to poor oral absorption, large first-pass metabolism, or a combination of both. The use of iX Biopharma’s WaferiX sublingual technology potentially allows for the improvement of its bioavailability as the delivery of the drug bypasses the first-pass metabolism, and hence offers a more rapid and predictable dosage of melatonin.
With millions of business and leisure travellers today taking flights that cross multiple time zones, flight dysrhythmia, or jet lag, has become a common phenomenon as these travellers experience a temporary misalignment between the body’s circadian clock and external time. The symptoms of jet lag, which include daytime fatigue, impaired alertness, night-time insomnia and impaired cognitive skills, can be addressed by melatonin, which regulates disturbed circadian rhythms and promotes sleep in jet lag and other circadian rhythm sleep disorders.
iX Biopharma has completed pre-clinical development of WafeRest, and commenced batch stability testing in FY2016. Upon completion of stability testing, the Group will file the product for export listing with the Australian Therapeutic Goods Administration for sale in the region. As a supplement, WafeRest does not require an additional clinical study (including in-human study) for registration. This means that the development cost for WafeRest is substantially lower and time-to-market is shorter compared to pharmaceutical products.
WafeRest is the first supplement in the Group’s pipeline of products, which also includes BnoX and Wafermine, a sublingual buprenorphine and a sublingual ketamine respectively, for acute and severe pain management; and PheoniX, a sublingual sildenafil for erectile dysfunction.
About iX Biopharma Ltd
iX Biopharma Ltd is a Singapore public-listed specialty pharmaceutical company, with manufacturing and laboratory testing facilities in Australia. The Group is focused on the development and commercialisation of innovative therapies for improving the quality of life of those suffering from pain and other health issues. The Company leverages its patented sublingual drug delivery technology, WaferiX, to develop proprietary products that incorporate pharmacologically active compounds that have been approved by the United States Food and Drug Administration. Its portfolio of products under development includes Wafermine and BnoX for pain management, PheoniX for erectile dysfunction, and WafeRest for improved sleep quality.
• Lower cost of development and shorter time-to-market compared to pharmaceutical products
Singapore, 17 August 2016 – Homegrown specialty pharmaceutical company iX Biopharma Ltd. (“iX Biopharma” or, together with its subsidiaries, “the Group”) has completed pre-clinical development for WafeRest, a sublingual melatonin wafer supplement aimed to alleviate jet lag and improve sleep quality.
Melatonin is a hormone produced in the brain that regulates the circadian rhythm (sleep-wake cycle) and people’s ability to sleep. Research has shown that melatonin has a low absolute bioavailability either due to poor oral absorption, large first-pass metabolism, or a combination of both. The use of iX Biopharma’s WaferiX sublingual technology potentially allows for the improvement of its bioavailability as the delivery of the drug bypasses the first-pass metabolism, and hence offers a more rapid and predictable dosage of melatonin.
With millions of business and leisure travellers today taking flights that cross multiple time zones, flight dysrhythmia, or jet lag, has become a common phenomenon as these travellers experience a temporary misalignment between the body’s circadian clock and external time. The symptoms of jet lag, which include daytime fatigue, impaired alertness, night-time insomnia and impaired cognitive skills, can be addressed by melatonin, which regulates disturbed circadian rhythms and promotes sleep in jet lag and other circadian rhythm sleep disorders.
iX Biopharma has completed pre-clinical development of WafeRest, and commenced batch stability testing in FY2016. Upon completion of stability testing, the Group will file the product for export listing with the Australian Therapeutic Goods Administration for sale in the region. As a supplement, WafeRest does not require an additional clinical study (including in-human study) for registration. This means that the development cost for WafeRest is substantially lower and time-to-market is shorter compared to pharmaceutical products.
WafeRest is the first supplement in the Group’s pipeline of products, which also includes BnoX and Wafermine, a sublingual buprenorphine and a sublingual ketamine respectively, for acute and severe pain management; and PheoniX, a sublingual sildenafil for erectile dysfunction.
About iX Biopharma Ltd
iX Biopharma Ltd is a Singapore public-listed specialty pharmaceutical company, with manufacturing and laboratory testing facilities in Australia. The Group is focused on the development and commercialisation of innovative therapies for improving the quality of life of those suffering from pain and other health issues. The Company leverages its patented sublingual drug delivery technology, WaferiX, to develop proprietary products that incorporate pharmacologically active compounds that have been approved by the United States Food and Drug Administration. Its portfolio of products under development includes Wafermine and BnoX for pain management, PheoniX for erectile dysfunction, and WafeRest for improved sleep quality.