InflaRx flatlines after skin disease drug flops in midstage trial

pharmaphorum | June 06, 2019

The phase 2b SHINE study of the anti-human complement factor C5a antibody was conducted in hidradenitis suppurativa (HS), a chronic inflammatory skin disease with limited treatment options that causes symptoms including inflamed nodules or boils in the armpits, groin and genital area. Unfortunately for InflaRx, the 179-patient study appears to be a near-total bust, with IFX-1 showing no improvement over placebo on symptoms after 16 weeks’ treatment. Most worryingly, there was no evidence of any dose response with the four IFX-1 dose levels tested, which was the trial’s primary endpoint, and the responses were significantly lower than had been previously reported in phase 2a. But for that earlier result it would be tempting to suggest that the primary problem is that C5a’s role in HS had been dramatically overstated. The only crumb of comfort for the Nasdaq-listed biotech came from a secondary endpoint – the dermatology life quality index (DLQI) – which just scraped a statistically significant improvement over placebo for the four IFX-1 groups as a whole.

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The medical science has evolved in its treatment and cures but the aspect of patient care has also come a long way. As medical care industry expands, nursing has become more than just observing and monitoring the patient. Modern medical facilities give major stress on patient’s experience throughout the stay and even continued attention after they are discharged. The growth of patient-centered care has shifted focus to the unique needs of each patient. Advanced nursing education systems, including RN to MSN online programs, have become more dynamic with the constant evolution of standards of care. Healthcare as we know it is changing. We must educate our nurses to be even more dynamic than our healthcare system, adapting to new models and standards of care.


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PHARMA TECH

ArisGlobal Accelerates Growth Announces Executive Evolution

ArisGlobal | September 08, 2022

ArisGlobal, the leading provider of life sciences software that automates core drug development functions with its end-to-end technology platform LifeSphere®, today announces an expansion to its C-suite. James Jarrett is the company's new Chief Financial Officer, Kathleen Turland joins as the first Chief Legal Officer, and Aman Wasan has stepped into the new role of Chief Commercial Officer. The three appointments are happening during a time of significant momentum for ArisGlobal, which has experienced annual recurring revenue growth of 34% in the first half of 2022 YoY. James Jarrett, Chief Financial Officer Jarrett brings over a decade of executive leadership experience driving revenue and cash flow growth. He has partnered with management teams and boards of directors of high-growth, highly leveraged companies undergoing rapid change. Prior to joining ArisGlobal, he served as the CFO for Emergence Health Holdings, Carewell Urgent Care, and ProCure Proton Therapy Center. Kathleen Turland, Chief Legal Officer Turland is a global strategic leader with more than 20 years of legal experience. She brings her broad range of legal and business skills to ArisGlobal, having worked with companies experiencing significant growth and expansion over the years, including General Electric, and FUSE Group. She started her legal career in New York, clerking for a Federal Court Judge, and working at two revered New York law firms. Aman Wasan, Chief Commercial Officer Wasan is an expert in general management and commercial leadership with a deep understanding and knowledge of drug safety and clinical research. Since joining ArisGlobal in 2018, Wasan has excelled in six different positions, most recently as Senior Vice President of Global Commercials, where he managed global enterprise business. Before joining the ArisGlobal team, Wasan worked for Bioclinica as the company's Global Head of Safety and Regulatory Services. "As we continue scaling our business and building new functions to better serve our customer base, expanding our C-suite will help us execute our mission and further drive our success in the life sciences industry. James, Kathleen, and Aman carry a wealth of industry knowledge instrumental in empowering ArisGlobal to further expand its customer pipeline, continue to develop innovative technology, and maintain a role as a trusted leader in the market." CEO Mike Gordon Turland's addition to the company also represents consistent and focused efforts by ArisGlobal to continually put women in positions of leadership. Turland joins ArisGlobal veterans Ritu Shrivastava, Vice President Corporate Development, and Heidi Hattendorf, Vice President of Marketing, on the executive team. Currently, ArisGlobal also has women in core leadership positions across business, product, quality, people, and technology functions. About ArisGlobal ArisGlobal is led by passionate individuals who support life sciences leaders in developing and monitoring breakthrough medicines and therapies. With more than 35 years of expertise in the life sciences industry, ArisGlobal develops technology products within the platform LifeSphere to power pharmaceutical and biotech research and development. Building on our commitment to corporate social responsibility and sustainability initiatives, we give back to the communities where we live and work – in the U.S, Europe, India, Japan, and China.

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BUSINESS INSIGHTS

Kubota Vision Announces Collaboration Agreement with Leading Diabetes Center

PBOS | September 30, 2022

Kubota Vision Inc. a clinical-stage specialty ophthalmology company and a wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. announced today that the Company and Joslin Diabetes Center have entered into a material transfer and collaboration agreement for our Patient Based Ophthalmology Suite in-home optical coherence tomography device. Joslin Diabetes Center is conducting two clinical studies to evaluate the ability of PBOS to identify cases of diabetic macular edema that may need treatment compared to a commercially-available OCT device. The studies will be led by Dr. Paolo S. Silva at Joslin Diabetes Center. Dr. Silva is the Co-Chief of Telemedicine at the Beetham Eye Institute of the Joslin Diabetes Center. His work is focused on innovative and investigative work in a field at the intersection of clinical care and technology with the hope of providing an ideal model for the delivery of evidence-based, highly effective, and efficient diabetes eye care to the population that needs it the most. Joslin Diabetes Center, which is affiliated with Harvard Medical School, is a one-of-a-kind institution on the front lines of the world epidemic of diabetes — leading the battle to conquer diabetes in all of its forms through cutting-edge research and innovative approaches to clinical care and education. Dr. Silva stated, “Through these studies, we will determine if home-based in-home optical coherence tomography is useful in the evaluation of diabetic macular edema and how we monitor patients at risk for losing vision from the condition.” “Diabetic retinopathy is one of the most common diseases in the world. The use of our technology brings us great excitement as we continue to focus on the development of medical devices and explore further possibilities.” Ryo Kubota, MD, PhD, Chairman, President, and CEO of Kubota Vision Inc. About PBOS PBOS is a low cost, home-based, ophthalmic self-monitoring OCT device. This small handheld device addresses needs in mobile Health applications for self-monitoring of retina health by patients, in the home and in remote field locations. The PBOS aims to improve ophthalmic treatment outcomes in patients diagnosed with and treated for wet age-related macular degeneration, diabetic macular edema and other neovascular retinal diseases. PBOS is being designed to detect nascent disease progression and support patient re-treatment prior to irreversible vision loss due to disease progression. Key features are low cost and a patient-friendly design, to be used directly by patients at home. PBOS is being designed to capture changes in retinal anatomy. Network connectivity and cloud-based technologies are used to alert the patients and their physicians of disease progression and re-treatment needs. About Kubota Vision Inc. Kubota Vision Inc. is a wholly owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. committed to translating innovation into a diverse portfolio of drugs and devices to preserve and restore vision for millions of people worldwide. Kubota Pharmaceutical group’s pipeline includes a wearable device for myopia control using Kubota GlassTM technology and a handheld OCT device for the monitoring of neovascular retinal diseases, to be used directly by patients.

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BUSINESS INSIGHTS

Glaukos Licenses Iveena’s Investigational Keratoconus Therapy

iVeena and Glaukos | August 25, 2022

iVeena Delivery Systems Inc. a clinical stage biopharmaceutical company with developmental products in keratoconus and pediatric myopia, has entered into a strategic licensing agreement with Glaukos Corporation that grants Glaukos an exclusive global license to develop and commercialize IVMED-80, a pharmacologic treatment for keratoconus. Keratoconus, a rare corneal disorder, is the leading cause of primary full-thickness corneal transplantation in the United States. IVMED-80 is a proprietary disease modifying topical eye drop with orphan drug designation that upregulates lysyl oxidase and induces pharmacologic corneal crosslinking to strengthen the cornea and treat keratoconus. In a 6-month phase 1/2a clinical study, IVMED-80 met its primary endpoint of a statistically significant reduction in baseline-adjusted Kmax of 1.0 D relative to placebo. “We are pleased to complete this agreement with Glaukos. This deal validates the technology we have developed at iVeena to induce corneal crosslinking pharmacologically via eyedrops. Glaukos is a strong partner to complete development of this product where, if approved, patients will have an additional keratoconus treatment option.” iVeena CEO Jerry Simmons As part of the agreement Glaukos paid $10 Million upfront and will assume all costs associated with development and regulatory activities on IVMED-80. In addition, deal terms include the potential for both development and sales milestone payments as well as royalties on sales to iVeena. About iVeena iVeena Delivery Systems, Inc. is a privately held, clinical stage ophthalmology company developing disease-modifying pharmacologic innovations for refractive diseases. iVeena has licensed its lead asset to Glaukos Corporation, IVMED-80, an Orphan Drug Designated eye drop for keratoconus. iVeena is developing IVMED-85, a first in class, investigational eyedrop formulation for pediatric myopia where it plans to initiate a first in human clinical trial early 2023. About Glaukos Glaukos is an ophthalmic medical technology and pharmaceutical company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. Glaukos first developed Micro-Invasive Glaucoma Surgery (MIGS) as an alternative to the traditional glaucoma treatment paradigm, launching its first MIGS device commercially in 2012, and has since developed a portfolio of technologically distinct and leverageable platforms to support ongoing pharmaceutical and medical device innovations. Products or product candidates for each of these platforms are designed to advance the standard of care through better treatment options across the areas of glaucoma, corneal disorders and retinal diseases.

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BUSINESS INSIGHTS

AustinPx Names Elizabeth Hickman Chief Business Officer

AustinPx | September 28, 2022

AustinPx, Pharmaceutics and Manufacturing, a contract development and manufacturing organization announced the appointment of Elizabeth Hickman as Chief Business Officer. In this role, Ms. Hickman will be responsible for the Company’s CDMO business operations and strategy, including building capabilities and a team to deliver high-value solutions for pharmaceutical customers. Ms. Hickman is an accomplished business leader with over 15 years of experience with small and multi-billion-dollar CDMOs. Over her career, she has held business development and market strategy positions of increasing responsibility, most recently at West Pharmaceutical Services as Senior Director of Strategic Marketing, Services and Solutions where she was responsible for market expansion of the company’s contract development, testing and manufacturing services. Prior to joining West, Ms. Hickman led sales and marketing at Pharmatek Laboratories, where she helped grow the company’s services and revenues resulting in its successful acquisition by Catalent Pharma Solutions. Following Pharmatek’s acquisition, she continued to excel in market strategy and business development leadership roles with Catalent’s oral drug development business unit. Ms. Hickman has a BA in Microbiology from the University of Texas, Austin and an MBA from San Diego State University. "Elizabeth brings a sharp skillset and a wealth of CDMO experience to AustinPx," said Tim Scott, President and CEO for AustinPx. "She has a strong history of growing CDMOs as both a strategist and a team-builder. Elizabeth is unique in her ability to foster and create a culture that excels at providing client-centric services, and that is why she is such a tremendous asset for AustinPx. We are very fortunate to have her." As CBO at AustinPx, Ms. Hickman will focus on the strategic buildout of agile, best in class operations, systems, and teams. She will be responsible for all market strategy and communications, business development, project management, systems optimization, and data-driven processes that drive growth. "I am excited to be a part of AustinPx and join its impressive team of formulation and manufacturing scientists and operations staff. They are a true scientific powerhouse for our clients. My goal is to build on the Company’s strong foundation to develop a client-centric CDMO that consistently delivers exceptional service from initial engagement to product shipment. Ultimately, my passion is for the patients of our clients – if we can help get their drug candidates to the clinic faster, with better formulations and dosage forms, we can in turn impact more patients around the world." Elizabeth Hickman About AustinPx AustinPx, Pharmaceutics and Manufacturing is a contract development and manufacturing organization providing analytical and formulation development services and cGMP manufacturing for small molecule drugs. We specialize in phase-appropriate development strategies, speed to clinic and market strategies, and bioavailability enhancement of poorly soluble molecules - including our next generation amorphous dispersion platform, KinetiSol® Technology.

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Spotlight

The medical science has evolved in its treatment and cures but the aspect of patient care has also come a long way. As medical care industry expands, nursing has become more than just observing and monitoring the patient. Modern medical facilities give major stress on patient’s experience throughout the stay and even continued attention after they are discharged. The growth of patient-centered care has shifted focus to the unique needs of each patient. Advanced nursing education systems, including RN to MSN online programs, have become more dynamic with the constant evolution of standards of care. Healthcare as we know it is changing. We must educate our nurses to be even more dynamic than our healthcare system, adapting to new models and standards of care.

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