New US Provisional Patent Filing for Novel Oral Drug Delivery of Chloroquine and/or Hydroxychloroquine Complements Transdermal Patch for drug used globally for Malaria, Lupus and Rheumatoid Arthritis
VANCOUVER, BC, CANADA (April 23rd, 2020) – Codebase Ventures Inc. ("Codebase" or the "Company") (CSE: CODE - FSE: C5B – OTCQB: BKLLF), an investment company, is excited to expand on its announcement on April 16th, 2020, as it relates to a new delivery mechanism for decades old drug used to treat malaria, lupus and rheumatoid arthritis.
Adding to the previously announced provisional patent filing for a transdermal patch delivery of hydroxychloroquine, the private company with which Codebase has entered into an arms-length agreement to acquire a 49% interest, Glanis Pharmaceuticals Inc, has filed for an additional US provisional patent for the novel oral drug delivery of hydroxychloroquine (HCQ) and chloroquine (CQ).
“With the previously announced transdermal patch filing, and now this novel oral delivery filing, steps are advancing quickly to satisfy a need for an improved drug delivery system of CQ and HCQ, which can replace the multiple dosage regimen associated with oral tablets and also decrease the probabilities of getting side effects related to GI tract disturbance,” said Codebase President and CEO, Mr. George Tsafalas.
- CODE has agreed to acquire a 49% interest in a private company that has secured the rights to the recently applied provisional patent application for a novel oral drug delivery system for hydroxychloroquine (HCQ), in addition to the previously announced transdermal patch provisional patent filing
- This transformative delivery system will initially seek approval through the FDA 505(b)(2) accelerated pathway provisions
- These new drug delivery systems could potentially provide an innovation for those long-term patients suffering from malaria, lupus and rheumatoid arthritis who have depended on HCQ for decades and have had to accept the side effects related to oral tablet delivery
- While there has been widespread publicity concerning HCQ as a treatment for Covid-19, there has been no recognized drug trial results to date.
In oral mucosal drug delivery, an oral mucosal patch or orally disintegrating composition is applied to the mucosal surface of the oral cavity. Throughout the duration of the application of an oral mucosal patch or oral disintegrating composition, the drug is continuously released and delivered through the intact mucosa to achieve systemic effect. Therefore, once applied, oral disintegrating composition or oral mucosal method can deliver drug into systemic circulation throughout the day. Currently, RRL has started evaluating the possibility of delivering HCQ for more than one day using their novel oral drug delivery system.
Oral mucosal delivery can reduce the dosing frequency of chloroquine (CQ) and hydroxychloroquine (HCQ) which is currently administered orally 2-3 times a day. Moreover, in oral mucosal drug delivery, the drug is delivered slowly and continuously throughout the duration of oral application hence there are no peaks and troughs in drug plasma concentration which are associated with multiple dose administration in a day. With respect to CQ and HCQ, it is expected that adverse effects in patients will be less with the oral mucosal delivery as drug plasma concentration with oral mucosal delivery is less than peak plasma concentration associated with oral tablets.
As consideration for this additional provisional patent and on-going work, the Company will issue up to 6 million common shares and pay $20,000 USD pursuant to a lab services agreement with a New York based laboratory, Reformulation Research Laboratories Inc. (RRL), that developed the patent application and the underlying technology. These shares will be issued at a deemed price of $0.05 per share. The agreement is subject to closing conditions usually found in transactions of this kind.
While hydroxychloroquine is the subject of various early studies of its effectiveness against the Covid-19, its present on-label uses as a treatment against malaria, lupus and rheumatoid arthritis provides a ready market for this proposed new delivery system. This new delivery method can eliminate or reduce a number of the common side effects of this treatment, including nausea, vomiting, loss of appetite, diarrhea, dizziness, or headache by providing a controlled constant delivery.
RRL has a combined 75 years of expertise in novel drug delivery systems that provide the capacity, equipment and capabilities to advance the development program for a hydroxychloroquine molecule for oral mucosal delivery from research, testing, regulatory approvals through to launch of the hydroxychloroquine oral mucosal delivery system.
The Company’s scientific expert has read and approved the scientific disclosures contained in the press release. The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the Covid-19 at this time. RRL is not making any express or implied claims that any of its products have the ability to deliver hydroxychloroquine through transdermal/oral at this time.