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

Dramatic changes in U.S. healthcare over the last few years have forced a rethinking of the partnerships pharmaceutical companies to form with groups representing patients and families. inVentiv Health Public Relations Group interviewed dozens of patient advocacy organizations to understand how they view the changes and what they seek from their pharma partners.

Spotlight

Dramatic changes in U.S. healthcare over the last few years have forced a rethinking of the partnerships pharmaceutical companies to form with groups representing patients and families. inVentiv Health Public Relations Group interviewed dozens of patient advocacy organizations to understand how they view the changes and what they seek from their pharma partners.

Related News

PHARMACY MARKET

McKesson Collaborates with Vanderbilt Health Rx Solutions to Expand Integrated Pharmacy Services

McKesson Corporation, Vanderbilt Health Rx Solutions | March 18, 2021

McKesson Corporation, a worldwide healthcare organization, reports another cooperation with Vanderbilt Health Rx Solutions (VHRxS), a public chief in specialty pharmacy technique and execution, to offer VHRxS's full suite of specialty pharmacy consulting services to McKesson's health system clients. This new, specialized offering from VHRxS will supplement the experience of McKesson, which has offered industry-driving pharmacy services for over 40 years, by bringing the skill of VHRxS, which was established by Vanderbilt University Medical Center to propel the mission of health systems specialty drug stores cross country. The new help will offer altered specialty pharmacy services and development procedures to emergency clinics and health systems in each period of their development. VHRxS's portfolio of strong specialty pharmacy consulting services will help health systems improve patient and supplier fulfillment while making new income transfers by fully coordinating pharmacy services into specialty centers. Scott Miller, president of McKesson Health Systems, shares, “Our teams work closely with customers to understand their challenges and this was a clear need for health systems addressing their specialty pharmacy capabilities. Along with our existing portfolio of services and solutions, this is one more way customers can achieve more for their hospitals and patients by creating new or strengthening existing revenue streams.” McKesson's pharmacy chiefs and the VHRxS group of experienced, involved counsels comprehend the requirements and difficulties of health system specialty drug stores. The groups have profound experience working with health systems altogether phases of development, from creating and carrying out starting specialty pharmacy development methodologies to improving existing activities to arrive at the following level. Jim Hayman, president of VHRxS and Chief Pharmacy Officer at Vanderbilt Health, states, “By collaborating with McKesson, we can better extend our expertise as a leading health system-based specialty pharmacy provider to help our peers. We know from experience that investing in your specialty pharmacy operations boosts patient and provider satisfaction, which reaps seen and unseen benefits many times over.” About McKesson Corporation McKesson Corporation is a global leader in healthcare supply chain management solutions, retail pharmacy, community oncology and specialty care, and healthcare information solutions. McKesson partners with pharmaceutical manufacturers, providers, pharmacies, governments and other organizations in healthcare to help provide the right medicines, medical products and healthcare services to the right patients at the right time, safely and cost-effectively. United by our ICARE shared principles, our employees work every day to innovate and deliver opportunities that make our customers and partners more successful all for the better health of patients. About Vanderbilt Health Rx Solutions Vanderbilt Health Rx Solutions (VHRxS) is a national specialty pharmacy strategy and management company founded and operated by Vanderbilt University Medical Center (VUMC), Middle Tennessee’s largest private employer and the largest academic medical center in the Mid-South with over 2.5 million patient encounters annually. VHRxS uniquely and effectively addresses the specialty pharmacy needs of companies, hospitals and health systems through building patient-centered, clinically integrated specialty pharmacy programs in collaboration with health system clients and leading employers. Founded on VUMC’s historic global leadership in clinical pharmacology, best-in-class specialty pharmacy operations and employee health plan performance, VHRxS draws on years of hands-on experience creating and executing specialty pharmacy strategies to help clients build successful programs of their own.

Read More

PHARMACY MARKET

Eirion Therapeutics Announces Strategic Agreement for HTL Biotechnology to Become Eirion's Exclusive Botulinum API Manufacturer

Eirion Therapeutics, Inc. | September 09, 2021

Eirion Therapeutics, Inc., an aesthetic dermatology company headquartered in Woburn, Massachusetts, announced that HTL Biotechnology, the worldwide leader in biotechnology solutions using hyaluronic acid and other biopolymers, will become Eirion's exclusive botulinum active pharmaceutical ingredient (API) manufacturer. Botulinum is the active ingredient in Eirion's lead product candidate ET-01, a topical neuromodulator being developed for Crow's Feet wrinkles and primary axillary hyperhidrosis (excessive sweating) that is currently in Phase 2 clinical trials, as well as in their liquid injectable neuromodulator product candidate being developed for glabellar wrinkles, AI-09. As part of the agreement, HTL will build, validate and operate a botulinum manufacturing facility in the US. In the future, HTL expects to apply to the CDC to have the facility certified to manufacture botulinum and later apply to the FDA to have it certified as a GMP plant. Under the agreement, HTL will pay for the construction, the validation and the operation of the US manufacturing facility, which is expected to become operational in 2022. In exchange, Eirion will begin paying manufacturing fees to HTL in 2023, with HTL also later sharing in the potential commercial success of ET-01 and AI-09, if approved. "This agreement marks an important expansion of HTL's biotechnology platform beyond our already industry-leading work in hyaluronic acid and bio-polymer manufacturing, as well as a key milestone in HTL's expanding footprint in North America," commented HTL CEO Yvon Bastard. "HTL believes that Eirion's products could be game-changers in the aesthetic field thanks to their substantial benefits for patients. Providing leading, innovative companies with the solutions that will empower them to change the lives of patients is our core purpose, which explains why we are particularly excited by this partnership" added Charles Ruban, HTL deputy CEO. About Eirion Therapeutics, Inc. Eirion Therapeutics, Inc. is a privately held, clinical stage biopharmaceutical company that is developing next-generation prescription products for aesthetic dermatology. Eirion currently has a rich pipeline of products focusing on treatments for wrinkles, primary axillary hyperhidrosis, androgenic alopecia, and hair greying. In the future, Eirion plans to also pursue additional indications that address other major unmet clinical needs for physicians and their patients. Earlier this year, Eirion closed a $40 million investment and licensing deal with Shanghai Haohai Biological Technology Ltd in China.

Read More

BUSINESS INSIGHTS

Resilience Establishes Multi-Product Development and Manufacturing Collaboration with Takeda’s Plasma-Derived Therapies Business Unit

Resilience | February 16, 2022

National Resilience, Inc. a technology-focused manufacturing company dedicated to broadening access to complex medicines, announced a manufacturing services agreement with Takeda’s Plasma-Derived Therapies Business Unit. As part of the agreement, Resilience will focus on supporting the development and manufacture of multiple products in Takeda’s plasma-derived medicines portfolio out of its facility in Mississauga, Ontario. “I’m proud to establish this relationship with Takeda, a company that has been pioneering plasma-derived therapies for more than 75 years. By bringing new technologies and innovation to biomanufacturing, we aim to help companies like Takeda reach more patients in need.” Rahul Singhvi, Sc.D., Chief Executive Officer of Resilience Resilience’s 136,000 sq ft (12,800 m2) biomanufacturing facility in Mississauga provides process and analytical development, scale up, drug substance and drug product / fill finish manufacturing for a variety of medicines. “We are delighted to form this strategic collaboration with Resilience, leveraging their expertise in both plasma therapy development and manufacturing to complement our current infrastructure and capabilities,” said Andreas Liebminger, Head of Pharmaceutical Sciences and Devices for the Plasma-Derived Therapies Business Unit at Takeda. “Our partnership will allow us to optimally use our combined assets to continue to bolster our portfolio, drive innovation and help more patients around the world realize the benefits of plasma medicines.” About Resilience Resilience is a technology-focused manufacturing company dedicated to broadening access to complex medicines. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. By continuously advancing the science of biopharmaceutical manufacturing and development, Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives.

Read More