ELEUSIS THERAPEUTICS LTD

Depression can be treated by many drugs, but for many patients the available therapies just aren’t good enough. Treatment-resistant depression remains an unmet medical need and psychedelic compounds make up a growing area of research in the hunt for better behavioral medications. For one type of psychedelic, dosing poses challenges. Scientists at Lusaris Therapeutics believe their approach can win out and the biotech startup has raised $60 million to bring its lead drug candidate into human testing. The molecule that Lusaris is working with has an unwieldy scientific name that’s typically shortened to the slightly more manageable 5-MeO-DMT. This old drug, which is found in the secretions of some plants and the glands of the Sonoran Desert toad, sparks a psychedelic effect. The drug can be synthesized in a lab but demand for the substance as it is found in nature has created a market that is reportedly endangering the toad. Regardless of the source of 5-MeO-DMT, how it is dosed matters. When taken orally, enzymes in the gut and liver rapidly metabolize it, rendering the molecule useless as a drug. Those taking 5-MeO-DMT for spiritual or therapeutic uses typically smoke it. The old-fashioned pill is still the way most people prefer taking their medications. Lusaris is developing an oral version of 5-MeO-DMT with a twist. Its pill, code-named LSR-1019, is designed to be placed under the tongue where it then rapidly dissolves and is absorbed by the body, said interim CEO Andrew Levin. The fast-acting drug’s effects start within minutes and are gone after about half an hour. Though the psychedelic effect disappears after the drug wears off, its benefit lasts much longer, Levin said. The drug works by neuroplasticity, which is the brain’s ability to change. Lusaris aims to make its therapy a one-time treatment. Levin said evidence from others’ tests of 5-MeO-DMT indicate that the compound is effective for at least a week. He added that patients have told the company the effect can last much longer, perhaps up to one year. “We don’t have hard data on that, we need to study it,” Levin said. “A very high percentage of patients with a single administration can get dramatically better. How long that effect lasts, we don’t know for any individual.” Lusaris was formed and incubated by RA Capital Management, where Levin is partner and managing director. The venture capital firm has invested in numerous companies but it also starts them. Formed by a team with neuroscience expertise, Levin said Lusaris went looking for compounds that have a high potential of efficacy, strong safety, and could benefit patients in a large area of unmet medical need. They settled on 5-MeO-DMT for addressing treatment-resistant depression, which is defined as depression inadequately treated by two earlier lines of therapy. RA Capital got a closer look at 5-MeO-DMT through an earlier investment. Last year, the firm co-led GH Research’s $125 million Series B financing. The Dublin-based company’s lead program, GH001, is an aerosolized version of 5-MeO-DMT that’s inhaled. The now publicly traded company has reached Phase 1/2 testing. GH Research is also developing two additional versions of the drug, one for intranasal delivery and the other for injection. The company aims to offer these therapies as drug-device combination products. Meanwhile, Beckley Psytech is preparing to advance to Phase 2 testing in depression and alcohol use disorder with its intranasally administered formulation of 5-MeO-DMT, codenamed BPL-003. The Oxford, England-based company has also expanded its pipeline. Last week, Beckley announced it agreed to acquire Eleusis Therapeutics, a company developing a Phase 1-ready infused formulation of the psychedelic compound psilocybin. The deal, an all-stock transaction, follows the unraveling of the SPAC merger that Eleusis announced at the beginning of this year. Rapid degradation of 5-MeO-DMT in the gut is specific to that compound rather than characteristic of psychedelics broadly, said Neil Buckley, Lusaris’s chief operating officer. Psilocybin can be taken orally. Ketamine can also be dosed orally. Johnson & Johnson’s Spravato, whose active ingredient is ketamine, was developed for intranasal administration, which Buckley said offers a more rapid effect on the brain. In choosing to work with 5-MeO-DMT, Lusaris decided on a different route of administration. “We saw drawbacks from other technologies and products in development,” Buckley said. “We ultimately wanted something that removed the burden [to patients].” The technology Lusaris uses to make its drug an orally disintegrating tablet comes from Catalent. Called Zydis, this technology is part of more than 35 commercialized products, including migraine drug Nurtec ODT. That drug was a relative latecomer in the newest class of migraine therapies called CGRP inhibitors, but its maker, Biohaven, has described the quick-dissolving formulation as a patient-preferred differentiator against rival products that are infused or injected. Lusaris has licensed the rights to Zydis for all applications of 5-MeO-DMT. That means the biotech’s research with its molecule and the Catalent technology could go beyond treatment-resistant depression. Lusaris is also developing therapies for migraine and cluster headache. One discovery-stage program, LSR-2000, is similar to depression drug LSR-1019, Levin said. A third program, LSR-3000, is a next-generation neuroplastogen in the discovery stage for other neuropsychiatric and neurological disorders. With this program, Lusaris is dialing out receptor activity that causes hallucinogenic effects in order to allow the drug to be dosed chronically. Lusaris’s funding announced this week is a Series A round. Other participants in the financing are Venrock, Deep Track Capital, Boxer Capital, and one additional undisclosed investor. Levin said the capital should support Lusaris into 2025. He expects to bring lead program LSR-1019 “to the clinic soon.” In addition to testing the molecule in treatment-resistant depression, Lusaris plans additional tests of that drug in other indications that the company is still selecting. In the near term, the startup is selecting office space. Though Lusaris was incorporated in Boston, it will set up shop in the Research Triangle Park region of North Carolina, where Buckley is based. Half of the employees will be based at that site while the other half will work virtually, Buckley said. Photo by Flickr user Jernej Furman via a Creative Commons license

MELBOURNE, Australia, June 01, 2021 (GLOBE NEWSWIRE) -- Opthea Limited (ASX:OPT; Nasdaq:OPT), a clinical stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, is pleased to announce the appointments of Dr. Julia Haller and Ms. Judith Robertson as independent Non-Executive Directors to its Board of Directors, effective June 1, 2021. Dr. Haller is an internationally recognized ophthalmologist and vitreoretinal surgeon, currently serving as Ophthalmologist-in-Chief and William Tasman, MD Endowed Chair at Wills Eye Hospital in Philadelphia. Ms. Robertson is an accomplished life sciences commercial executive with an extensive track record for building, leading and launching several commercial organizations and products including successfully launching multiple ophthalmic products for pharmaceutical and biotechnology companies. “We are delighted to welcome Dr. Haller and Ms. Robertson to the Opthea Board of Directors. Both are recognized leaders in their respective fields. Their extensive expertise and advice will be instrumental as we progress OPT-302 through its pivotal Phase 3 clinical trials with top-line data on track for 2023 and, if successful, through commercialization,” commented Dr. Jeremy Levin, Opthea’s Chairman of the Board. “Building the Board has been an important milestone in our journey to potentially bring a unique medicine to address the unmet needs of those with retinal diseases.” Dr. Julia Haller, Ophthalmologist-in-Chief and William Tasman, MD Endowed Chair at Wills Eye Hospital, serves as Professor and Chair of the Department of Ophthalmology at Sidney Kimmel Medical College at Thomas Jefferson University and is a recognized authority in therapies to treat and prevent blindness, having published over 350 scientific articles and book chapters. She is also on the Board of Directors of Bristol Myers Squibb and President of the John Hopkins Medical and Surgical Association. Dr. Haller previously served on the Board of Celgene Corporation (acquired by Bristol Myers Squibb). In addition to serving on numerous boards, Dr. Haller serves as chair of the American Ophthalmological Society’s Council, vice chair of the College of Physicians of Philadelphia and chair of the Society of Heed Fellows. She is a member of the National Academy of Medicine, and president of the Women in Medicine Legacy Foundation. Dr. Haller received her Bachelor of Arts from Princeton University, graduating magna cum laude, and completed her medical training at Harvard Medical School. Her previous appointments include Professor of Ophthalmology, Johns Hopkins University School of Medicine, The Wilmer Eye Institute. Ms. Judith Robertson, most recently Chief Commercial Officer of Eleusis Ltd, was previously Chief Commercial Officer of Aerie Pharmaceuticals, where she oversaw the launch of Rhopressa®, the first product targeting a new mechanism of action for the treatment of glaucoma in 20 years, and the launch of the combination product Rocklatan®. Prior to Aerie, Ms. Robertson was Global Commercial Vice President Immunology and Ophthalmology at Johnson and Johnson, Janssen Pharmaceuticals, and Global Vice President Ophthalmology at Novartis (formerly Alcon). Her prior experience also includes several senior executive commercial roles at Novartis, Searle and Bristol Myers Squibb including President and General Manager of Bristol Myers Squibb Canada. In addition to Opthea, Ms. Robertson serves on the Board of Durect Corporation, a Nasdaq listed company developing therapies for acute organ injury and chronic liver diseases. Ms. Robertson holds a Bachelor of Arts (Honors) degree from Ryerson University in Canada and an MBA from Northwestern University, Kellogg School of Management in Chicago. About Opthea Opthea (ASX:OPT; Nasdaq:OPT) is a biopharmaceutical company developing novel therapies to address the unmet need in the treatment of highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Opthea’s lead product candidate OPT-302 is in pivotal Phase 3 clinical trials and being developed for use in combination with anti-VEGF-A monotherapies to achieve broader inhibition of the VEGF family, with the goal of improving overall efficacy and demonstrating superior vision gains over that which can be achieved by inhibiting VEGF-A alone. Inherent risks of Investment in Biotechnology Companies There are a number of inherent risks associated with the development of pharmaceutical products to a marketable stage. The lengthy clinical trial process is designed to assess the safety and efficacy of a drug prior to commercialization and a significant proportion of drugs fail one or both of these criteria. Other risks include uncertainty of patent protection and proprietary rights, whether patent applications and issued patents will offer adequate protection to enable product development, the obtaining of necessary drug regulatory authority approvals and difficulties caused by the rapid advancements in technology. Companies such as Opthea are dependent on the success of their research and development projects and on the ability to attract funding to support these activities. Investment in research and development projects cannot be assessed on the same fundamentals as trading and manufacturing enterprises. Therefore, investment in companies specializing in drug development must be regarded as highly speculative. Opthea strongly recommends that professional investment advice be sought prior to such investments. Forward-looking statements Certain statements in this announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statement describing Company goals, expectations, intentions or beliefs is a forward-looking statement and should be considered an at risk statement, including, but not limited to, the continuation of patient recruitment for Opthea’s pivotal Phase 3 clinical trials of OPT-302 in wet AMD. Such statements are based on Opthea’s current plans, objectives, estimates, expectations and intentions and are subject to certain risks and uncertainties, including risks and uncertainties associated with clinical trials and product development and the impact of general economic, industry or political conditions in Australia, the United States or internationally. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the final prospectus filed with the SEC on October 19, 2020. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required under applicable law. You should not place undue reliance on these forward-looking statements as predictions of future events, which statements apply only as of the date of this announcement. Actual results could differ materially from those discussed in this ASX announcement. Authorized for release to ASX by Megan Baldwin, CEO & Managing Director