PHARMACY MARKET

Tarsier Pharma Raises Capital to Execute Phase-3 Clinical Trial

Tarsier Pharma | August 28, 2021

Tarsier Pharma, a late clinical stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat patients with blinding ocular diseases, today announced it raised capital to execute a phase-3 clinical trial of its TRS01 program in the US and Europe. Strategic and new investors alongside existing investors participated in this transaction.

Following a successful End of Phase II meeting with the FDA, the Company obtained all necessary regulatory approvals to execute phase 3 and has recruited leading uveitis experts as principal investigators. Tarsier plans to enroll the first patient in Q4 of 2021.

Tarsier's technology, TRS, is a novel immunomodulator molecule that showed, in a dose-ranging, randomized, double-masked phase I\II trial in the target indication, a prompt and statistically significant improvement in signs and symptoms of uveitis.

"We are excited to have the support of our existing and new investors, as we continue our clinical development of TRS01 in advanced stages," said Dr. Haim Langford, CEO of Tarsier. "Looking ahead, we are eager to bring our lead product to market and simultaneously progress our development of important pipeline projects for other back-of -the-eye blinding diseases, and plan to raise additional capital to realize these as well."

About Tarsier Pharma
Tarsier Pharma is a late clinical stage pharmaceutical company, phase-3 ready, focused on the discovery, development, and commercialization of first-in-class pharmaceutical therapies to treat ocular blinding diseases. TRS is a breakthrough proprietary technology platform, based on a new bio-inspired chemical entity, with novel mechanism of action and demonstrated safety and efficacy in a rare debilitating and blinding indication.

Lead product candidate for uveitic glaucoma
Non-infectious uveitis is an autoimmune blinding ocular inflammation, considered the third leading cause of blindness in the developed world. Tarsier's TRS01 is a potent fast-acting immunomodulator, delivered as eye drops, for the treatment of non-infectious anterior uveitis in patients with uveitic glaucoma – considered an end-stage condition of uveitis. Once a uveitis patient has also developed glaucoma (uveitic glaucoma), the only available treatments for active inflammation, which are steroids, should be avoided, due to their negative side effects in expediting glaucoma and vision loss. Thus, TRS01 has the potential to become the standard of care for uveitic glaucoma.

Spotlight

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Spotlight

For starters, by severely restricting food anorexics limit the amount of energy and nutrients their bodies receive. This triggers a chain of bodily reactions which can have fatal outcomes. Your brain, the epicenter of all bodily functions suffers a massive blow due to malnutrition. As a result, it starts shrinking, causing physiological and psychological damage.

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PHARMACY MARKET

Baseball Legend John Smoltz Featured on PLx Pharma’s Social Channels

PLx Pharma Inc. | September 13, 2022

PLx Pharma Inc. is a commercial-stage drug delivery platform technology company focused on its clinically-validated and patent-protected PLxGuard™ that has the potential to improve the absorption of many drugs currently on the market and to reduce the risk of stomach injury associated with certain drugs. The Company, with its lead products VAZALORE 81 mg and VAZALORE 325 mg liquid-filled aspirin capsules has launched a new VAZALORE 325 mg advertising campaign on Facebook featuring legendary professional baseball pitcher and avid golfer John Smoltz. “From baseball to golf, I don’t want aches and pains to slow me down,” said Smoltz. “VAZALORE is the only pain reliever I have found that works quickly on my aches and pains and doesn’t upset my stomach.” “September is Pain Awareness Month, a time dedicated to raising awareness of pain and pain management options, like aspirin. We are very excited to launch our new Facebook campaign with John, a current VAZALORE user and believer in its many benefits. Millions of people rely on aspirin for the temporary relief of minor aches and pains. The unique complex inside VAZALORE capsules allows for targeted release of aspirin to temporarily relieve minor aches and pains and is specially designed to help protect the stomach.” Natasha Giordano, President & CEO of PLx Pharma PLx Pharma’s VAZALORE is the first and only U.S. Food and Drug Administration (FDA)-approved liquid-filled aspirin capsule. The product was launched in August 2021 and is available over the counter in more than 30,000 drugstores, supermarkets, mass merchandisers and e-commerce sites nationwide. About VAZALORE VAZALORE is an FDA-approved liquid-filled aspirin capsule, available in 81 mg and 325 mg doses. VAZALORE delivers aspirin differently from plain and enteric coated aspirin products. The special complex inside the capsule is designed for targeted release of aspirin, limiting its direct contact with the stomach. VAZALORE delivers fast, reliable absorption for pain relief plus the lifesaving benefits of aspirin. About PLx Pharma Inc. PLx Pharma Inc. is a commercial-stage drug delivery platform technology company focused on improving how and where active pharmaceutical ingredients (APIs) are absorbed in the gastrointestinal (GI) tract via its clinically validated and patent protected PLxGuard™ technology. PLx believes this platform has the potential to improve the absorption of many drugs currently on the market or in development, and to reduce the risk of stomach injury associated with certain drugs.

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BUSINESS INSIGHTS, PHARMACY MARKET

RespireRx Pharmaceuticals Inc. Enters a Collaboration With National Institute for Neurological Disorders and Stroke to Advance its Lead GABAkine

RespireRX Pharmaceuticals Inc. | December 06, 2022

RespireRx Pharmaceuticals Inc. a leader in the discovery and development of innovative and revolutionary treatments to combat diseases caused by disruption of neuronal signaling, is pleased to announce that RespireRx has been accepted into the NIH HEAL Initiative® NINDS Preclinical Screening Platform for Pain program. The Company’s lead GABAkine, KRM-II-81, has been shown to be effective in relieving acute, chronic, and neuropathic pain in a number of models without tolerance development or sedation. The Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative, is an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. Launched in April 2018, the initiative is focused on improving prevention and treatment strategies for opioid misuse and addiction, and enhancing pain management. The PSPP program, part of the NIH HEAL Initiative, evaluates non-opioid assets in a battery of established preclinical models. The PSPP program accepts small molecules, biologics, devices, or natural products for evaluation, from researchers in academia and industry worldwide. The RespireRx team is led by Dr. Arnold Lippa, RespireRx Executive Chairman and Chief Scientific Officer and Drs. James M. Cook, Jeffrey M. Witkin and Rok Cerne, all of whom are RespireRx Research Fellows in addition to their academic affiliations at University of Wisconsin-Milwaukee, Ascension St. Vincent and Indiana University/Purdue University, respectively. The team has extensive expertise in drug discovery and development including the development of novel analgesic drugs and an extensive publication record with a combined total of over 1,000 scientific publications. The team has already profiled KRM-II-81 activity in a broad range of preclinical studies where it has displayed a high degree of analgesic activity and is excited at the prospect of advancing the Companay’s lead GABAkine toward clinical development. In cellular studies, KRM-II-81 preferentially bound to specific subtypes of GABAA receptors and boosted the ability of GABA to inhibit pain sensory neurons in the spinal dorsal root ganglia. In intact animal models of acute and chronic pain, the analgesic efficacy of KRM-II-81 was comparable to or greater than commonly used analgesics. At the same time, KRM-II-81 did not display side effects such as sedation and motor impairment, but even more importantly, it did not produce tolerance, dependence, respiratory depression, or behavioral changes indicative of abuse liability, which are produced by opioid narcotics and are at the heart of the opioid epidemic. Unrelated to the NINDS project, KRM-II-81 has also shown promising results in multiple animal models of treatment resistant epilepsy and in human translational studies by reducing epileptiform electrical signaling in brain tissue removed from treatment resistant epileptic patients undergoing surgery. Dr. Cerne commented “We believe that the expansion of our understanding of GABAA receptor structure and function has created a new surge in the discovery and development of GABAkines that target such receptors in a unique manner. This opens the promise of improved medicines for pain, epilepsy and other disorders caused by disruption of neuronal signaling.” “We are very excited about developing KRM-II-81 and expanding the IND enabling studies so as to begin human studies. Pending clinical validation, we believe that KRM-II-81 has the potential to represent a breakthrough treatment for pain, epilepsy, and other neuropsychiatric disorders.” Dr. Lippa About RespireRx Pharmaceuticals Inc. RespireRx Pharmaceuticals Inc. is a leader in the discovery and development of medicines for the treatment of psychiatric and neurological disorders, with a focus on treatments that address conditions affecting millions of people, but for which there are few or poor treatment options, including attention deficit hyperactivity disorder epilepsy, pain, recovery from spinal cord injury ertain neurological orphan diseases and obstructive sleep apnea. RespireRx is developing a pipeline of new and re-purposed drug products based on our broad patent portfolios for two drug platforms: (i) pharmaceutical cannabinoids, which include dronabinol, a synthetic form of ∆9-tetrahydrocannabinol that acts upon the nervous system’s endogenous cannabinoid receptors and (ii) neuromodulators, which include AMPAkines and GABAkines, proprietary chemical entities that positively modulate AMPA-type glutamate receptors and GABAA receptors, respectively. The Company holds exclusive licenses and owns patents and patent applications or rights thereto for certain families of chemical compounds that claim the chemical structures and their uses in the treatment of a variety of disorders, as well as claims for novel uses of known drugs. EndeavourRx: Neuromodulators GABAkines. Under a License Agreement with the University of Wisconsin-Milwaukee Research Foundation, Inc. and on behalf of its EndeavourRx business unit, RespireRx has licensed rights to certain selectively acting GABAkines because of their ability to selectively amplify inhibitory neurotransmission at a highly specific, subset of GABAA receptors, thus producing a unique efficacy profile with reduced side effects. Preclinical studies have documented their efficacy in a broad array of animal models of interrelated neurological and psychiatric disorders including epilepsy, pain, anxiety, and depression in the absence of or with greatly reduced propensity to produce sedation, motor-impairment, tolerance, dependence and abuse. The Company currently is focusing on developing KRM-II-81 for the treatment of epilepsy and pain.

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BUSINESS INSIGHTS

Astellas and MBC BioLabs Announce Astellas Future Innovator Prize to Help Biotech Start-ups Accelerate Early Drug Discovery and Research Efforts

Astellas Pharma Inc. | September 20, 2022

Astellas Venture Management LLC a wholly-owned venture capital subsidiary of Astellas Pharma Inc. and Mission Bay Capital BioLabs a life-science incubator, today announced their collaboration on the "Astellas Future Innovator Prize" formerly known as the Astellas Golden Ticket competition. Building on over three successful years, the competition offers entrepreneurial scientists or emerging biotechnology start-ups one year's priority usage of MBC BioLabs' state-of-the-art lab facility and access to Astellas' research and development (R&D) capabilities and business leaders. With a shared commitment to discovering and advancing innovative science for the potential future benefit of patients worldwide, AVM and MBC BioLabs are continuing their partnership to support scientists and early-stage companies to accelerate their novel therapeutic programs, modalities or platforms. The 2022 competition will prioritize innovative research that compliment Astellas' Focus Area Approach and pipeline. "We are truly thrilled to host the Astellas Future Innovator Prize again this year. Through our long-term collaboration with MBC BioLabs, we aim to create an environment that encourages innovation to thrive. The Astellas Future Innovator Prize enables us to provide biotech companies with expertise and capabilities to turn an innovative idea into a real solution, which could transform the lives of patients in need around the world." William Watt, President, AVM "We are pleased to continue our partnership with Astellas to uncover the innovators of tomorrow," said Douglas Crawford, MBC BioLabs General Manager. "The past winners of the Astellas Future Innovator Prize show what can be achieved by combining Astellas' support, advice and expertise with our laboratory incubator, and we are excited to see the result of our ongoing collaboration." Entrepreneurial scientists, emerging life-science and biotechnology start-ups have until November 4, 2022 to enter the Astellas Future Innovator Prize. About the Astellas Future Innovator Prize at MBC BioLabs Astellas is offering up to two prizes for pioneering scientists with innovative research that complements Astellas' areas of interest in alignment with its Focus Area Approach and pipeline, including Blindness & Regeneration, Mitochondria, Genetic Regulation, Immuno-Oncology, Cell Therapy, and other areas. The 2021 Astellas Future Innovator Prize winners were Vcreate and Weatherwax Biotechnologies, chosen for the potential of their innovations to deliver therapeutic advances for unmet medical needs and their potential synergy with Astellas' Focus Area Approach. About Astellas Venture Management LLC AVM is the wholly-owned venture capital organization within Astellas, dedicated to supporting pre-clinical, cutting-edge science that can bring VALUE to patients. For over 15 years, AVM has provided equity investments to private, early-stage companies developing therapeutic programs and platform technologies, helping them to advance their innovations faster. AVM is a strategic investor, making investments in science that will enhance the current Astellas R&D pipeline or that could catalyze new directions in discovery research. About Astellas Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. About MBC BioLabs MBC BioLabs is dedicated to helping life-science startups succeed. By renting space as small as a single bench and providing these entrepreneurial scientists with access to millions of dollars of equipment, MBC BioLabs allows companies to be fast, focused, and frugal. It has three sites: one in the Dogpatch neighborhood in San Francisco and two campuses in San Carlos, California. Each site has a complete molecular biology core facility that allows companies to do experiments on day one. MBC BioLabs has partnerships with leading pharmaceutical and life-science companies as well as a built-in venture capital firm, Mission BioCapital. These partnerships provide entrepreneurs with valuable insights about where to focus their efforts and accelerates the innovation pipeline. Since opening in 2013, MBC BioLabs has helped launch and grow 290 companies. These companies have brought 58 programs to the clinic, produced 13 approved diagnostics, and raised over $14 billion.

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