RESEARCH

NRx Pharmaceuticals Announces New Finding from ZYESAMI™ (aviptadil) Phase 2b/3 Clinical Trial

NRx Pharmaceuticals | August 30, 2021

NRx Pharmaceuticals announced an additional finding in its phase 2b/3 clinical trial investigating ZYESAMI™ (aviptadil) for the treatment of patients with acute Respiratory Failure due to Critical COVID-19. Previously announced results have focused on survival and recovery from respiratory failure at 60 days, and ZYESAMI's apparent role in preventing rise in the inflammatory cytokine IL-6, known as "Cytokine Storm."

NRx's new analysis shows that patients treated with ZYESAMI demonstrated improvement in blood oxygen, indicative of improved lung function, within a day of starting treatment. The average difference in Respiratory Distress Ratio between those treated with aviptadil and placebo was both clinically meaningful and statistically significant. Moreover, the difference is comparable to that reported a year ago from an open label study at Houston Methodist Hospital by Dr. J Georges Yousef.

"With the conclusion of the analysis of primary and secondary endpoints, we are able to focus on prespecified endpoints that confirm mechanism of action," said Prof Jonathan Javitt, MD, MPH, Chairman and CEO of NRx. "COVID-19 attacks the cells that line the lung in a manner that prevents them from transmitting oxygen to the body. It is this respiratory failure that starts the lethal process of COVID," This latest analysis provides confirmatory evidence that aviptadil improves the lung's ability to transmit oxygen within a day of initiating treatment. The benefit was seen across all patients, all baseline severities, and all types of hospitals. We believe this new finding illustrates ZYESAMI's mechanism of action in a placebo-controlled trial and supports our application for Breakthrough Therapy Designation to the FDA."

Prior data regarding reduced respiratory distress were reported by Dr. J. Georges Youssef, Head of Academic Pulmonary Medicine at Houston Methodist Hospital one year ago. Dr. Youssef and colleagues reported the results in 21 patients treated with ZYESAMI, compared to 24 patients who received best-available standard of care.

This latest analysis also supports NRx's application for Breakthrough Therapy Designation (BTD) to the FDA for ZYESAMI. BTD is a process designed to expedite the development and review of medicines intended to treat a serious condition and is supported by preliminary clinical evidence showing the drug may demonstrate substantial improvement over available therapies on a clinically significant endpoint(s). https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy

About ZYESAMI™/VIP in COVID-19
ZYESAMI (aviptadil) is a synthetic form of Vasoactive Intestinal Polypeptide (VIP) first discovered by the late Prof. Sami Said in 1970, and ZYESAMI™ is named in his honor. Although primarily concentrated in the lung, it was first purified from the intestinal tract. VIP binds specifically to the alveolar type II cell (ATII) in the air sac (alveolus) of the lung, where it has been shown have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation. Most importantly, VIP stimulates ATII cells to make the surfactant that must coat the lining of the lungs in order for them to exchange oxygen with the blood. Loss of surfactant causes respiratory failure and alveolar collapse, which are hallmarks of COVID-19.

About NRx Pharmaceuticals
NRx Pharmaceuticals draws upon more than 300 years of collective, scientific and drug-development experience to bring improved health to patients. Its investigational product, ZYESAMI™ (aviptadil) for patients with COVID-19, has been granted Fast Track designation by the US Food and Drug Administration (FDA) and is currently undergoing phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority, a part of the US Department of Health and Human Services, and the Medical Countermeasures program, part of the US Department of Defense. The FDA has additionally granted Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support to NRx for NRX-101, an investigational medicine to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readouts expected in 2022. NRx currently has the BriLife for COVID-19 in phase 3 trials, and holds the exclusive worldwide license to commercialize the vaccine. The BriLife vaccine was first developed by the Israel Institute for Biological Research.

Spotlight

In today’s hypercompetitive pharmaceutical and life sciences (PLS) industry, strategic partnerships are more critical than ever. A smaller life sciences company may have
relationships with hundreds of healthcare providers and healthcare organizations. 

Spotlight

In today’s hypercompetitive pharmaceutical and life sciences (PLS) industry, strategic partnerships are more critical than ever. A smaller life sciences company may have
relationships with hundreds of healthcare providers and healthcare organizations. 

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MedRhythms Recognized for Advancements in Prescription Digital Therapeutics from CB Insights, Reuters Events Pharma and Fast Company

MedRhythms | December 12, 2022

CB Insights today announced that, for the second year in a row, MedRhythms has been named to its annual Digital Health 150, a list that showcases the 150 most promising private digital health companies. This recognition comes a week after MedRhythms received the Most Valuable Digital Therapy award at the Reuters Events Pharma Awards ceremony and less than a month after MedRhythms was named a Fast Company Next Big Things in Tech honoree for the progress that the company has made on its products and their potential to improve access to high quality care. "From reimagining clinical care, to leveraging tech like AR/VR to improve surgical training, this year's Digital Health 150 winners are transforming the future of healthcare with digital technology. This increasingly global cohort, representing more than 18 countries across five continents, is not only driving better patient outcomes, but making healthcare more accessible. We are excited to follow the meaningful impact and continued success of this year's winners." Brian Lee, SVP of CB Insights' Intelligence Unit "Being recognized as a leader in the industry by CB Insights, Reuters Events Pharma and Fast Company is an incredible honor and is a testament to our entire team's commitment to our mission to positively impact the lives of those living with neurologic injury and disease," said Brian Harris, CEO and Co-Founder of MedRhythms. "These recognitions serve as validation of our team's progress to date and, more importantly, as motivation to keep advancing as we push the envelope in healthcare by building next-generation neurotherapeutics that leverage the power of music to bring important interventions to patients around the world." Utilizing the CB Insights platform, the research team selected these 150 winners from a pool of over 13,000 private companies, including applicants and nominees. 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Since raising the Series B financing, MedRhythms has announced that the company has entered into collaborations with Universal Music Group (UMG), the world's largest record label for music content and data, and Biogen, one of the first global biotechnology companies. MedRhythms' most advanced product, which addresses gait impairment in chronic stroke, received Breakthrough Device designation from the U.S. Food and Drug Administration. Earlier this year, MedRhythms finalized a worldwide licensing agreement worth up to $120M with Biogen for the company's second product, which targets gait impairment in multiple sclerosis. In addition to these two assets, the company has a strong pipeline in large markets with high unmet needs and is conducting feasibility studies in collaboration with some of the world's leading clinicians and researchers. 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Innovation Pharmaceuticals Announces BT BeaMedical Technologies Receives FDA Clearance for New Surgical Laser Family

Innovation Pharmaceuticals Inc | November 29, 2022

BT BeaMedical Technologies a private company developing a next-generation laser-based platform for epilepsy and cancer surgery, has notified Innovation Pharmaceuticals that it has received U.S. Food and Drug Administration clearance for its MANTA surgical laser family. The clearance is an important milestone for BeaMed in its development of an advanced laser technology with respect to shaping energy and matching it to patient specific anatomy, a novel concept that BeaMed is proving a reality. Innovation Pharmaceuticals made a strategic investment to acquire a minority stake in BeaMed in June 2022. BeaMed is the inventor and developer of the StingRay Laser System a novel laser-based thermal ablation technology designed for treatment of previously inoperable cases of epilepsy and for improvement of outcomes and enablement of new treatment options for oncology procedures, including those treating brain, prostate, liver, breast, and lung cancers. The StingRay Laser System will utilize the MANTA laser family as its core energy generation devices coupled to new fiber optic technology, allowing a perfect match between the exact structure of tumors and epileptic focal points and the energy delivery, while protecting vital functional areas against thermal damage. The MANTA surgical laser family was cleared by the FDA including five different wavelengths and soft tissue use in a very wide set of clinical specialties, including Neurosurgery, Spinal Surgery, Urology, Thoracic Surgery, Pulmonary Surgery, Gynecology, General Surgery, ENT/Head and Neck, Plastic Surgery, Orthopedics, Arthroscopy, Ophthalmology, Radiology, and Oral Surgery. BeaMed expects to soon make requisite submissions to the FDA for clearance of its fiber optics for use in multiple medical indications. “We are excited with the speed of progress BeaMed is making towards introduction of its new platform product with the potential to help millions of patients globally suffering from epilepsy and cancer in multiple specialties. The execution of this submission and the speed of clearance speaks volumes to the commercialization strategy and the exceptional capabilities of the regulatory team at BeaMed,” Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals “This is an exciting and important milestone for our company. This clearance gives us two key achievements. First, U.S. market access to a wide range of potential laser energy sources, each allowing us different and unique tissue interaction, an achievement which will have wide clinical implications. The second is a very wide set of intended uses covering many key potential markets for our technology. This underscores the clear regulatory strategy of BeaMed, which goes hand in hand with our broad impact business vision of revolutionizing key treatments, including brain tumors, epilepsy, lung cancer, prostate cancer, breast cancer and more,” said Gil Shapira, co-founder of BeaMed. BeaMed was founded by Moshe Eshkol and Gil Shapira, both highly experienced specialists in surgical lasers and medical devices. BeaMed and the development of the StingRay system are also supported by a special prestigious grant from the BIRD Foundation a bi-national organization supporting Israel-US collaboration. Gil Shapira brings forward 26+ years of engineering and product development and management experience, with over 17 years in the surgical laser industry. Gil owns and manages neoLaser, a company he founded in 2012, and led to revenue growth and profitability, with a 43% CAGR on its way to more than 1200 global installations and performing 50,000+ surgeries annually in over 30 countries. Previously, Gil led product development and marketing at OmniGuide, a successful high-growth laser-based medical device spin-off out of the Massachusetts Institute of Technology. About Innovation Pharmaceuticals Innovation Pharmaceuticals Inc. is a clinical stage biopharmaceutical company developing a portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, and infectious diseases. The Company is also active in evaluating other potential investment opportunities that can add value and diversify its portfolio.

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