PharmaDrug's Sairiyo Therapeutics Submits Clinical Trial Application for Phase 1 Study of Patented Reformulated Cepharanthine

Rhea-AI Summary

PharmaDrug's Sairiyo Therapeutics has filed a clinical trial application with the Australian Human Research Ethics Committee for a Phase 1 study of its patented reformulated cepharanthine (PD-001). This study will evaluate the bioavailability and pharmacokinetics of 30 mg and 60 mg enteric-coated capsules compared to 6 mg tablets in healthy volunteers. If approved in June 2024, this trial will be the first human test of PD-001, aimed at treating infectious diseases and oncology. Sairiyo's Australian subsidiary will sponsor the study. The initiative leverages Australia's drug development incentives, offering a 43.5% tax rebate. Successful completion may lead to FDA applications for further trials in the U.S.

Positive

• Submission of a clinical trial application for PD-001 marks a significant step toward human trials.
• Potential to treat both infectious diseases and oncology expands the market scope.
• First-in-human study boosts credibility and investor confidence.
• Leverages Australian drug development incentives with a 43.5% tax rebate, reducing financial burdens.
• Future plans to submit an Investigational New Drug application to the FDA for Phase 2 and Phase 3 trials in the U.S.

Negative

• Approval for the clinical study is still pending from the Australian Human Research Ethics Committee.
• Potential risks include failure to achieve desired outcomes in Phase 1, affecting subsequent phases.
• The competitive landscape in infectious diseases and oncology could limit market penetration.
• No immediate revenue-generating activities from this study, leading to continued financial strain.

Toronto, Ontario--(Newsfile Corp. - May 15, 2024) - PharmaDrug Inc. (CSE: PHRX) (OTC Pink: LMLLF) ("PharmaDrug" or the "Company"), a specialty pharmaceutical company focused on the research, development and commercialization of controlled-substances and natural medicines such as psychedelics and previously approved drugs, is pleased to announce that Sairiyo Therapeutics Inc. ("Sairiyo"), a company that is fifty-one percent (51%) owned by PharmaDrug and fourty-nine percent (49%) owned by PharmaTher Holdings Ltd. (CSE: PHRM) (OTCQB: PHRRF) ("PharmaTher"), has submitted to the Australian Human Research Ethics Committee for review and potential approval to initiate a Phase 1 clinical study (the "Study") of Sairiyo's patented reformulated enteric coated version of orally bioavailable cepharanthine ("PD-001") as a potential treatment for infectious diseases and oncology.

Robert Steen, CEO and Chairman of PharmaDrug commented, "We are extremely excited to have cepharanthine on the verge of the next phase in its development and evolution. Having a first in human trial for PD-001 can provide the data needed to augment a FDA phase 2 or phase 3 clinical trial application."

The Phase 1 study entitled "Phase 1 Open-label, Single Dose, 3-Way Cross-Over Trial to Assess in Healthy Volunteers the Bioavailability and Pharmacokinetics Of 30 mg and 60 mg Oral Enteric Coated Capsules of Cepharanthine Dihydrochloride in Comparison to 6 mg Oral Cepharanthine Dihydrochloride Tablets," if approved by the Australian regulators in June 2024, will be a first-in-human study of PD-001. Sairiyo's wholly-owned subsidiary in Australia, Sairiyo Therapeutics Australia Pty Ltd., is the sponsor of the Study.

In pursuit of its clinical strategy for PD-001, Sairiyo aims to conduct its first-in-human clinical study of PD-001 in Australia to capitalize on drug development incentives in Australia, which could earn a 43.5 percent rebate from the Australian Federal Government's Research and Development tax incentive program. Upon completion of the clinical study, Sairiyo intends to submit an Investigational New Drug application for PD-001 to the U.S. Food and Drug Administration (FDA) to commence Phase 2 and Phase 3 clinical trials in the United States.

About PD-001 (Enteric-coated Oral Cepharanthine)

Cepharanthine is a natural product and an approved drug used for more than 70 years in Japan to successfully treat a variety of acute and chronic diseases. In clinical research, cepharanthine has been shown to exhibit multiple pharmacological properties including anti-oxidative, anti-inflammatory, immuno-regulatory, anti-cancer, anti-viral and anti-parasitic effects^1,2. However, historically cepharanthine's low oral bioavailability has represented a major obstacle to realizing its full clinical potential.

Compared to generic cepharanthine, PD-001 has been shown in rodent and non-rodent models to possess markedly improved oral bioavailability (more easily absorbed). These findings support the development of an orally administered formulation, and in so doing, removes the undesirable requirement for frequent intravenous dosing to maintain therapeutic levels of drug in circulation. Sairiyo endeavours to develop an efficacious oral therapeutic to potentially improve outcomes for infectious disease and oncology applications.

PD-001 is protected by US Patent US10576077, with a patent expiration date of March 23, 2036.

About PharmaDrug Inc.

PharmaDrug is a specialty pharmaceutical company focused on the research, development and commercialization of controlled-substances and natural medicines such as psychedelics and previously approved drugs. PharmaDrug owns 51% of Sairiyo Therapeutics ("Sairiyo"), a biotech company that specializes in researching and reformulating established natural medicines with a goal of bringing them through clinical trials and the associated regulatory approval process in the US and Europe. Sairiyo is currently developing its patented reformulation of cepharanthine, a drug that has shown substantial third party validated potential for the treatment of infectious disease and rare cancers. Sairiyo is also conducting R&D in the psychedelics space for the treatment of non-neuropsychiatric conditions. PharmaDrug also owns 100% of SecureDose Synthetics Inc. ("SecureDose"), a pharmaceutical research and development company focused on the development of synthetic formulations of currently existing drugs for potential commercialization and distribution.

For further information, please contact:

Robert J. Steen, Chairman and CEO
rob@pharmadrug.ca
(416) 400-7086

Caution Regarding Forward-Looking Information:

THE CANADIAN SECURITIES EXCHANGE HAS NOT REVIEWED NOR DOES IT ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

This news release may contain forward-looking statements and information based on current expectations. These statements should not be read as guarantees of future performance or results of the Company. Forward-looking statements in this press release relate to the integration of the SecureDose business, the ability achieve the anticipated benefits of the Transaction and the development of the Company's business. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements.

Forward-looking information is subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of the Company to be materially different from those expressed or implied by such forward-looking information. Such risks and other factors may include, but are not limited to: general business, economic, competitive, political and social uncertainties; general capital market conditions and market prices for securities; the actual results of the Company's future operations; competition; changes in legislation affecting the Company; the ability to obtain and maintain required permits and approvals, the timing and availability of external financing on acceptable terms; lack of qualified, skilled labour or loss of key individuals..

A description of additional risk factors that may cause actual results to differ materially from forward-looking information can be found in the Company's disclosure documents on the SEDAR+ website at www.sedarplus.ca. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. Accordingly, readers should not place undue reliance on forward-looking information. Readers are cautioned that the foregoing list of factors is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking information as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.

The Company's securities have not been registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), or applicable state securities laws, and may not be offered or sold to, or for the account or benefit of, persons in the United States or "U.S. Persons", as such term is defined in Regulations under the U.S. Securities Act, absent registration or an applicable exemption from such registration requirements. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in the United States or any jurisdiction in which such offer, solicitation or sale would be unlawful.

Forward-looking information contained in this press release is expressly qualified by this cautionary statement. The forward-looking information contained in this press release represents the expectations of the Company as of the date of this press release and, accordingly, are subject to change after such date. However, the Company expressly disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as expressly required by applicable securities law.

References:

1. Saito T, Hikita M, Kohno K, Tanimura H, Miyahara M, Kobayashi M. Enhanced expression of the multidrug resistance gene in vindesine-resistant human esophageal cancer cells. Oncology. 1994 Sep-Oct;51(5):440-5. doi: 10.1159/000227380. PMID: 8052486.
2. Zhou P, Zhang R, Wang Y, Xu D, Zhang L, Qin J, Su G, Feng Y, Chen H, You S, Rui W, Liu H, Chen S, Chen H, Wang Y. Cepharanthine hydrochloride reverses the mdr1 (P-glycoprotein)-mediated esophageal squamous cell carcinoma cell cisplatin resistance through JNK and p53 signals. Oncotarget. 2017 Nov 27;8(67):111144-111160. doi: 10.18632/oncotarget.22676. Erratum in: Oncotarget. 2021 Jan 05;12(1):61-62. PMID: 29340044; PMCID: PMC5762312.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/209160

FAQ

What clinical trial did Sairiyo Therapeutics submit for in May 2024?

Sairiyo Therapeutics submitted a clinical trial application for a Phase 1 study of its patented reformulated cepharanthine (PD-001).

When is the Phase 1 study of PD-001 expected to be approved?

The Phase 1 study is expected to be approved by June 2024.

What is the aim of the Phase 1 trial for PD-001?

The Phase 1 trial aims to assess the bioavailability and pharmacokinetics of 30 mg and 60 mg enteric-coated capsules of cepharanthine in healthy volunteers.

What incentives does Sairiyo Therapeutics expect to benefit from in Australia?

Sairiyo Therapeutics could earn a 43.5% rebate from the Australian Federal Government's Research and Development tax incentive program.

What are the potential applications for PD-001?

PD-001 aims to treat infectious diseases and oncology.

What are the next steps if the Phase 1 trial is successful?

If successful, Sairiyo plans to submit an Investigational New Drug application to the FDA for Phase 2 and Phase 3 trials in the U.S.