Palatin Technologies, Inc | December 29, 2021
Palatin Technologies, Inc. a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin peptide receptor system, announced the initiation of the pivotal Phase 3 MELODY-1 clinical study of PL9643 in patients with dry eye disease. The study is designed to enroll up to 400 patients at multiple U.S. sites, and top-line results are currently expected second half calendar 2022.
"We are excited to initiate the MELODY-1 study of PL9643 in patients suffering from dry eye disease. This is the second melanocortin peptide Palatin has advanced into Phase 3, demonstrating Palatin's expertise and efficiency in melanocortin peptide development for indications with unmet medical need."
Carl Spana, Ph.D., CEO and President of Palatin
The pivotal Phase 3 MELODY-1 clinical study is a multi-center, randomized, double–masked and vehicle–controlled study evaluating the safety and efficacy of the melanocortin agonist, PL9643 ophthalmic solution, compared to vehicle in subjects with dry eye disease . The study design is based on positive Phase 2 results of PL9643 for the treatment of dry eye disease, and an end-of-phase 2 meeting with the with the U.S. Food and Drug Administration, reaching agreement on all key elements of a pivotal Phase 3 clinical program, including study design, endpoints, interim assessment, and patient population. In addition, to support a New Drug Application filing, a second phase 3 study and long-term safety study will be required. If the program progresses as planned, top-line results from MELODY-1 would be available second half calendar 2022, MELODY-2 data read out second half calendar 2023, with a potential NDA submission first half calendar 2024.
"Progressing PL9643 into Phase 3 is a significant milestone for the Company and patients with DED," said Michael Raizman, MD, Chief Medical Officer of Palatin. "PL9643, with its differentiating factors, could provide a more tolerable and effective treatment option for patients suffering from dry eye disease."
About Dry Eye Disease
Dry eye disease is a common inflammatory disease that, left untreated, can become extremely painful and lead to permanent damage to the cornea and vision. Dry eye disease affects the cornea and conjunctiva of the eye resulting in irritation, redness, pain, and blurred vision. It is estimated to affect over 20 million people in the United States. The disease is characterized by insufficient moisture and lubrication in the anterior surface of the eye, leading to dryness, inflammation, pain, discomfort, irritation, diminished quality of life, and in severe cases, permanent vision impairment. Existing therapy for dry eye disease is generally regarded as inadequate by many physicians and patients, and often requires week or months to demonstrate activity.
About Melanocortin Receptor Agonists and Inflammation
The melanocortin receptor system has effects on inflammation, immune system responses, metabolism, food intake, and sexual function. There are five melanocortin receptors, MC1r through MC5r. Modulation of these receptors, through use of receptor-specific agonists, which activate receptor function, or receptor-specific antagonists, which block receptor function, can have medically significant pharmacological effects.
Many tissues and immune cells located in the eye express melanocortin receptors, empowering our opportunity to directly activate natural pathways to resolve disease inflammation.
Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. Palatin's strategy is to develop products and then form marketing collaborations with industry leaders to maximize their commercial potential.
RegeneRx Biopharmaceuticals, Inc. | September 28, 2021
RegeneRx Biopharmaceuticals, Inc., a clinical-stage drug development company focused on tissue protection, repair and regeneration), announced that GtreeBNT, the licensee for several RegeneRx products, is being acquired by HLB Group, a Korean company that includes six biopharmaceutical and financial subsidiaries in Korea and the U.S.
GtreeBNT announced that as part of its acquisition the company would issue approximately US$80 million of new stock and convertible bonds to HLB Group to fund ongoing programs. The new capital should speed up the clinical trials currently in progress and allow the company to focus on new drug approval. RGN-259 will remain a priority for the company.
HLB's recommended executives are expected to be appointed at the general meeting scheduled for October 29, 2021. Won Yang, the current CEO of GtreeBNT, is expected to remain as the chief research officer and continue to lead the development of new drugs after the acquisition.
RegeneRx has scheduled its 2021 Annual Stockholder Meeting for November 10, 2021 and hopes to have additional details on the acquisition and its effect on GtreeBNT's clinical development activities and timing related to RGN-259 and RGN-137, products developed for the treatment of dry eye syndrome, neurotrophic keratitis, and epidermolysis bullosa.
The fact that GtreeBNT will receive a significant capital infusion related to the transaction, we believe, should benefit the development of the products we licensed to the company. As soon as practicable after we receive any new information from the new management related to our products we will update our stockholders.
- J.J. Finkelstein, president and chief executive.
About RegeneRx Biopharmaceuticals, Inc.
RegeneRx is focused on the development of novel therapeutic peptides, including Thymosin beta 4 (Tβ4) and its constituent fragments, for tissue and organ protection, repair, and regeneration. RegeneRx currently has three drug candidates in clinical development for ophthalmic, cardiac/neuro and dermal indications, four active strategic licensing agreements in the U.S., China, and Pan Asia (Korea, Japan, and Australia, among others), and the EU, and has patents and patent applications covering its products in many countries throughout the world.
CELL AND GENE THERAPY
Integral Molecular | August 02, 2021
Integral Molecular, the industry leader in membrane proteins, announces the launch of GeneCanvas, its proprietary protein engineering platform to optimize transgenes and other gene therapy elements.
GeneCanvas can achieve 10 to 100 fold increases in gene activity by improving transgene protein expression, trafficking, stability, and function. These enhancements will ultimately result in better efficacy, smaller doses, and improved safety for patients.
The GeneCanvas platform is built on Integral Molecular's 20 years of experience in optimizing the most challenging and structurally complex proteins known, such as GCPRs, ion channels, transporters, and viral envelopes. GeneCanvas incorporates the company's proprietary high-throughput mutagenesis and human cell screening platforms that enable the creation and screening of large libraries of variants, which have been used in hundreds of projects internally and for partners.
"Our scientists bring an unrivaled mix of deep expertise in protein engineering, cell biology, and virology to develop a customized strategy for each engineering challenge," said Joseph Rucker, PhD, Vice-president of Research and Development at Integral Molecular.
About Integral Molecular
Integral Molecular is the industry leader in discovering and characterizing therapeutic antibodies against membrane proteins, an important group of drug targets found on the surfaces of cells and viruses. Integral Molecular's technologies have been integrated into the drug discovery pipelines of over 400 biotech and pharmaceutical companies to help discover new therapies for cancer, diabetes, autoimmune disorders and viral threats such as SARS-CoV-2, Ebola, Zika, and dengue viruses.