Love Pharma (CSE:LUV) Co said Naltrexone has been identified to show promise in the treatment of long COVID-19 and also announced that it has completed the previously announced acquisition of Doc Hygiene Pharmaceuticals Inc.
Last week, Love Pharma (CSE:LUV) announced the signing of a non-binding Letter of Intent (LOI) to acquire Naltrexone Therapeutics Inc, a pharmaceutical technology company with significant intellectual property (IP) related to the transdermal delivery of Naltrexone, an opioid antagonist, primarily used to manage alcohol and or opioid-use disorder.
Four clinical trials are currently being planned to test Naltrexone in hundreds of long COVID patients, the company said, citing a report by Reuters on October 17.
The U.S. National Institutes of Health $1 billion RECOVER Initiative has shortlisted Naltrexone to be tested in relation to uncovering underlying causes and finding treatments for long COVID.
Love Pharma (CSE:LUV) noted that low-dose Naltrexone may actually reverse some underlying pathology driving long COVID symptoms, beyond treating those symptoms caused by COVID damaging organs.
Currently, Naltrexone is sold by several generic drug manufacturers in 50mg format, which is 10 times the low dose being considered for long COVID treatment, requiring low-dose prescriptions to be compounded, which limits access and availability. Although requiring further study, Naltrexone Therapeutics transdermal delivery IP may offer a patient-friendly, low-dose delivery solution that can be readily available to patients, Love Pharma (CSE:LUV) said.
READ: Love Pharma says subsidiary MicroDoz Therapy’s sponsored trial at Johns Hopkins University on track for 2022 launch
Transdermal delivery of Naltrexone
With significant promise in early applications in treating long COVID, it is anticipated that transdermal delivery of Naltrexone can provide a drug plasma concentration at a predetermined rate for a predetermined period of time.
Safe, consistent doses will make the drug much more effective at reduced dosages required because the gastrointestinal (GI) system is avoided with transdermal delivery.
The company said the transdermal formulation of a drug can be incorporated within a patch which is then applied to the skin surface of the patient.
A transdermal patch provides a consistent absorption rate over a pre-determined time as prescribed. The delivery method for transdermal delivery of suitable drugs can be highly flexible and can be applied for periods such as 24, 48, 72 , 96, 120, 144 hours - up to 7, 8, 13, 14 or 15 days.
Further, this type of delivery overcomes the challenge of multiple dosage regimens associated with oral applications and accurately reflects the proper dosage entering the patient's system to address the symptoms, while also circumventing the GI tract and related side effects.
LOI to buy Naltrexone Therapeutics
Love Pharma (CSE:LUV)'s acquisition of Naltrexone Therapeutics is considered an arms-length transaction with the company to become a wholly-owned subsidiary of Love Pharma for a total consideration of $2,000,000 payable in common shares of the issuer.
The company said it anticipates closing the transaction within 30 days subject to final due diligence, adding that further details will be released upon the signing of a definitive agreement.
US Food & Drug Administration (FDA)-approved Naltrexone acts by reducing cravings and feelings of euphoria associated with substance abuse disorder. Transdermal delivery of Naltrexone is expected to regulate dosage and improve patient experience while also eliminating or reducing current side effects of the drug such as nausea, which may restrict the growth of the existing Naltrexone market.
Love Pharma noted that it is not making any express or implied claims that its product has the ability to eliminate, cure or contain the Covid-19 (or SARS-2 Coronavirus) at this time.
Doc Hygiene purchase complements portfolio
Separately, announcing the completion of the Doc Hygiene acqusition, Love Pharma CEO Zach Stadnyk said in a statement: "We're excited to officially close Doc Hygiene and work with the company's proprietary Intellectual Property (IP), website and e-commerce platform, and established brand within the consumer-packaged goods space."
"We believe the completion of the acquisition further compliments our robust portfolio of exclusive IP within the consumer over-the-counter therapeutics," he added.
Love Pharma said the acquisition will give it access to Doc Hygiene’s associated registered trademarks, online eCommerce sales and marketing platforms, and social media accounts. In addition, it will receive Doc Hygiene's existing inventory of personal sanitizer products, which it negotiated at no cost to the company.
Under the terms of the share purchase agreement, the company paid a total of US$300,000 through the issuance of a convertible promissory note representing an aggregate principal amount of US$150,000, convertible into common shares in the capital of Love Pharma at a price equal to the lesser of $0.05 and the last trading price on the Canadian Securities Exchange prior to the conversion, and the assumption of US$150,000 of indebtedness of Doc Hygiene.
Love Pharma said the principal amount will be payable on the fifth year of the date of issuance of the note, at an interest rate of 10% per annum, payable quarterly in arrears.
As part of the acquisition, Love Pharma will also assume about US$150,000 of Doc Hygiene’s liabilities, it added.
Love Pharma was founded in 2020, with a mission to bring to market innovative products that enhance sexual health and wellness while providing an improved quality of life.
Love Pharma holds exclusive licenses to produce market, package, sell, and distribute patent-protected therapeutic and pharmaceutical products throughout Europe, the UK, and North America.
Contact the author at rachel.middleton@proactiveinvestors.com