ProtoKinetix Engages Multi-National Partner for Formulation of Topical Drug to Treat Dry Eye Disease & Ocular Inflammation with AAGP®

Rhea-AI Summary

ProtoKinetix (PKTX) has partnered with a global pharmaceutical firm to develop a topical ocular drug targeting dry eye disease (DED) using AAGP®. The company has completed essential studies, including ocular irritation tests and pre-clinical trials demonstrating efficacy. Upcoming tasks include finalizing formulations and obtaining FDA approval for clinical trials. The dry eye disease market, valued at approximately USD 4.5 billion in 2018, is projected to reach USD 6.2 billion by 2024, with an annual growth rate of 5.23%. This milestone is crucial for the commercialization of PKTX's DED program.

Positive

• Engagement with a global pharmaceutical company enhances development prospects for the ocular drug.
• Completion of multiple studies indicating progress in drug development for dry eye disease.

Negative

• None.

ProtoKinetix, Incorporated (the "Company" or "ProtoKinetix") (OTCQB: PKTX), a clinical-stage biomedical company, today announced that it has engaged a global pharmaceutical company to develop the formulation as a topical ocular drug for the treatment of dry eye disease (DED) and ocular inflammation using AAGP®.

For the development of this drug for DED to date the company has completed:

1. Ocular irritation studies
2. Proof of concept pre-clinical DED trials for efficacy
3. Confirmatory pre-clinical DED trials for efficacy
4. Pilot drug stability (ie. shelf-life) testing
5. Pilot tolerability and toxicology studies

All these studies were conducted by market-leading contract research organizations (CRO).

In order to progress to clinical trials, the Company intends to complete the following activities:

1. Complete topical application formulation(s)
2. Confirmatory DED efficacy tests
3. Drug product Good Lab Practice (GLP) IND-enabling safety toxicology
4. Communicate with Federal Drug Administration (FDA) on clinical trial design criteria

Dry Eye Disease Market Overview

According to market research published by Mordor Intelligence LLP, studies of the Dry Eye Disease market indicated a value of approximately USD 4.5 billion in 2018, and the market is expected to reach up to USD 6.2 billion by 2024, with an anticipated CAGR of 5.23%, during the forecast period (2019-2024). The growth of dry eye related diseases may include several factors, such as aging, a decrease in the supportive hormones (ex. menopause), systemic inflammatory diseases, ocular surfaces diseases or surgeries affecting the cholinergic nerves, which stimulate tear secretion.

“This is a critical milestone in our application development and moves us forward to commercialization of ProtoKinetix’s Dry Eye Disease program.” – Clarence Smith, CEO President

See the promising research of AAGP® and results to date

Visit our new website at ProtoKinetix.com for more information and to join our email list.

About ProtoKinetix, Incorporated

Cautionary Note Regarding Forward-Looking Statements

The information discussed in this press release includes “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. All statements, other than statements of historical facts, included herein concerning, among other things, planned capital expenditures, future cash flows and borrowings, pursuit of potential acquisition opportunities, our financial position, business strategy and other plans and objectives for future operations, are forward looking statements. Although we believe that the expectations reflected in these forward-looking statements are reasonable, they do involve certain assumptions, risks and uncertainties and are not (and should not be considered to be) guarantees of future performance. Refer to our risk factors set forth in our reports filed on Edgar. ProtoKinetix disclaims any obligation to update any forward-looking statement made here.

This press release does not constitute or form a part of any offer or solicitation to purchase or subscribe for securities in the United States.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210414005060/en/

FAQ

What is the latest development from ProtoKinetix (PKTX) regarding their ocular drug?

ProtoKinetix has partnered with a global pharmaceutical company to develop a topical ocular drug for dry eye disease.

What studies has ProtoKinetix (PKTX) completed for their dry eye disease drug?

The company has completed ocular irritation studies and multiple pre-clinical trials confirming efficacy.

What are ProtoKinetix's (PKTX) next steps for their ocular drug?

Next steps include completing drug formulations, confirmatory efficacy tests, and FDA communication for clinical trial design.

What is the projected market size for dry eye disease?

The dry eye disease market is expected to grow from USD 4.5 billion in 2018 to USD 6.2 billion by 2024.