Mycrodose Therapeutics Announces First Clinical Candidate for Ketamine-Based Drug Delivery Device for Oral Mucositis

San Diego, California--(Newsfile Corp. - March 31, 2022)

Mycrodose Therapeutics ("Mycrodose"), a leading US pharmaceutical company specializing in the development of advanced drug delivery technologies utilizing DEA Schedule I & III drugs and other compounds, announced today their lead clinical drug delivery system with a ketamine-based treatment for oral mucositis associated with cancer patients undergoing chemotherapy and radiation therapy. Mycrodose's first clinical candidate, MDT-001, is a controlled and sustained-release soft ketamine-based lozenge with a potential for reducing pain, inflammation, and allowing the oral mucosa to regrow tissue in cancer patients who have developed oral mucositis.

Oral mucositis is a painful and potentially treatment-limiting disorder often associated with radiation therapy and chemotherapy of the head, neck and throat cancers, yet mucositis also impacts a large percentage of patients being treated for other cancers. Oral mucositis often involves painful ulcerative lesions and inflammation of the oral mucosa. Cancer patients with oral mucositis can develop local and systemic infections, a significant weight loss due to a reduced nutritional intake, and painful radiation carries, which often results in patients needing to reduce or completely stop chemotherapy or radiation treatment.

"Radiation induced oral mucositis (RIOM) is a painful and potentially treatment-limiting side effect of radiotherapy for head and neck and other cancers. The incidence in head and neck cancers of RIOM can be as high as 100% and there are few treatments that currently have satisfactory results in reducing pain without short acting topicals or opiate-based compounds as well as the duration of the mucositis," said Dr. Christian Yavorsky, Chief Research Officer of Mycrodose Therapeutics. "We are looking forward to an expected IND meeting with the FDA to discuss the parameters of a Phase II clinical trial for our unique ketamine delivery system and look forward to providing further options for oncology patients experiencing this painful and treatment-limiting condition."

Mycrodose Therapeutics' clinical candidate, MDT-001, aims to determine efficacy compared to standard-of-care across a number of primary and secondary endpoints. These include the World Health Organization's (WHO) oral mucositis severity grading, visual analogue pain scales, and time to treatment discontinuation. Mycrodose is also interested in a range of experimental outcomes including measures of inflammation that will be used to enhance and inform the company's future research.

"Mycrodose Therapeutics has achieved significant milestones with our IP-protected core advanced drug delivery technologies, and we are looking forward to the possibilities of our first candidate, MDT-001. Mycrodose is very fortunate to have Co-Founder and Chief Science Officer, Frank Kochinke, leading the development of this product. His 35-plus years of experience and knowledge of developing advanced drug delivery systems in the pharmaceutical sector is our company's strongest asset, and this product stems from Frank's decade-long research of oral mucositis and his passion for finding a solution to help the millions of cancer patients currently suffering," said Chad Conner, Chief Executive Officer of Mycrodose Therapeutics. "Overall, it is very important that Mycrodose as a company select indications that result in objectively measured data and biomarkers that can be accurately measured, which is why we decided to lead with our lozenge technology, specifically paired with this exact indication, to create MDT-001. This lozenge for mucositis is the first of many technologies and indications that Mycrodose intends to bring into clinical trials this year."

About Mycrodose Therapeutics
Mycrodose Therapeutics Inc. is a U.S.-based pharmaceutical company headquartered in San Diego, California specializing in the development of advanced drug delivery systems utilizing DEA Schedule I & III drugs and other compounds to treat cancer related conditions, mental health, and cognitive degenerative diseases. Mycrodose's state-of-the-art laboratory includes a transdermal department with full in-vitro and analytical capacities that allows for all intellectual property and proprietary data to remain in-house. The company believes that its IP-Protected Sustained Microdosing Technology™ is a smarter and safer approach to delivering pharmaceutical compounds to patients of all ages and allows for an expandable and scalable business model.

For more information about Mycrodose Therapeutics, please contact:

Patrick Eckstrom
Chief Operating Officer
Mycrodose Therapeutics
Phone: 1-619-494-1367

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