BUSINESS INSIGHTS, PHARMA TECH
Koneksa | January 18, 2023
On January 17, 2023, Koneksa, a healthcare technology company that develops evidence-based validated digital biomarkers, announced the beginning of a clinical study that will compare the treatment effect of at-home mobile spirometry using digital biomarkers versus in-clinic spirometry in patients who have moderate asthma and are receiving long-acting beta-agonist (LABA) treatment.
The LEARN study is a single-arm interventional trial that compares the identification of treatment effects in people with moderate asthma using at-home mobile spirometry by utilizing an ultrasonic spirometer and a smartphone compared to in-clinic spirometry. Up to 60 people with mild, uncontrolled asthma who already use inhaled corticosteroids (ICS) will take part in the study. Besides, it will also cover those who need to take LABA medication for a six-week treatment period.
In-clinic spirometry can be performed at home with the same or higher accuracy compared to in-clinic and potentially less strain on the patient. The study will analyze the LABA treatment impact in clinic and mobile spirometry along with assessing the association between different readouts of mobile spirometry, in addition to evaluating asthma control as determined by the ACQ-6, a patient-reported outcome questionnaire. Other goals include assessing patient and site-specific satisfaction with mobile spirometry technology.
Chris Benko, CEO & Founder, Koneksa, stated, “This study builds on Koneksa's prior work demonstrating that mobile spirometry has the potential to detect clinically meaningful changes in very small cohorts of asthma patients on standard of care.” He further added, “The LEARN study will evaluate whether at-home mobile spirometry can detect treatment effects of a known positive control (LABA) in a significantly smaller population than would traditionally be assumed for an in-clinic proof-of-concept study.”
(Source – Business Wire)
Based out of New York, Koneksa is a patient-centric digital biomarker firm that develops end-to-end solutions for remotely obtained clinical data to expedite clinical research and guide decision-making in drug development and market strategy for the pharmaceutical and biotechnology industries. It seeks to revolutionize effect detection in clinical research by providing integrated solutions for efficient trial designs that yield more meaningful data. Its evidence-based biomarker solutions allow for more efficient clinical trial designs, allowing novel medicines to reach patients sooner.
PHARMACY MARKET, PHARMA TECH
Jazz Pharmaceuticals plc and Zymeworks Inc. | December 28, 2022
Jazz Pharmaceuticals plc and Zymeworks Inc. recently informed that the former has chosen to keep its exclusive rights to develop and sell Zymeworks' Zanidatamab in key markets, such as the U.S., Europe, and Japan, as part of the license and collaboration agreement made in October 2022.
A pivotal trial in previously treated HER2-amplified biliary tract tumors (BTC) found that 41.3% (95% CI: 30.4, 52.8) of recruited patients with HER2-amplified and expressing (IHC2+ and 3+) illness achieved an objective response as judged by independent central review. The median response length was 12.9 months (95% CI: 5.95 to not attained). In this trial, Zanidatamab's safety profile was similar to what had been found in previous studies of monotherapy, while no new safety signals were found.
Jazz Pharmaceuticals stated that the compelling top-line clinical data from the pivotal study in patients with BTC demonstrated the transformative potential of Zanidatamab. This big win gives the company more confidence that it can make this medicine better for cancer patients who have big unmet needs. Even though its main focus will be on the ongoing clinical trials for BTC and GEA, these data will add to the growing amount of evidence that Zanidatamab is effective against a wide range of HER2-expressing cancers.
Zymeworks expressed that the collaboration with Jazz is going well, which will speed up the global development of Zanidatamab in many types of cancer and may give patients with hard-to-treat cancers and few treatment options access to a basic HER2-targeted drug.
Jazz will pay Zymeworks $325 million to exercise its option to develop and sell Zanidatamab in all countries except Asia-Pacific in the fourth quarter of 2022.
About Jazz Pharmaceuticals
Jazz Pharmaceuticals, founded in 2003 and located in Dublin (Ireland), innovates to improve the lives of patients and their families. The company transforms biopharmaceutical discoveries into innovative medications to reimagine what's possible.
Zymeworks develops next-generation multifunctional biotherapeutics. Zanidatamab is a new Azymetric™ HER2-targeted bispecific antibody being examined in numerous Phase 1, Phase 2, and pivotal clinical trials globally as a targeted therapeutic option for patients with HER2-positive solid tumors. Zanidatamab Zovodotin (ZW49) is a bispecific antibody-drug combination in Phase 1 clinical development. It combines Zanidatamab's unique design and antibody framework with Zymeworks' ZymeLink™ linker-cytotoxin.
VIEWS AND ANALYSIS, PHARMACY MARKET
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. They were chosen based on factors including R&D activity, proprietary Mosaic scores, market potential, business relationships, investor profile, news sentiment analysis, competitive landscape, team strength, and tech novelty. The research team also reviewed over 3,000 Analyst Briefings submitted by applicants.
MedRhythms is pioneering the development of next-generation neurotherapeutics designed to improve walking, mobility and related functional outcomes via a proprietary, patented technology platform. The company's platform combines sensors, software, and music with advanced neuroscience to target neural circuitry. The company is developing a pipeline of digital therapeutics across a range of neurological conditions, including stroke, multiple sclerosis and Parkinson's disease. In 2021, MedRhythms announced an oversubscribed Series B financing round of $27M co-led by Morningside Ventures and Advantage Capital. 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.
About Fast Company
Fast Company is the only media brand fully dedicated to the vital intersection of business, innovation, and design, engaging the most influential leaders, companies, and thinkers on the future of business. The editor-in-chief is Brendan Vaughan. Headquartered in New York City, Fast Company is published by Mansueto Ventures LLC.
About Reuters Events Pharma
More open so that the strongest ideas and insights are brought to the fore in a transparent, trustworthy manner. More valued by having an authentic approach to building products and services that matter to patients.
MedRhythms is pioneering the development of next-generation neurotherapeutics designed to improve walking, mobility and related functional outcomes via a proprietary, patented technology platform. The company's platform combines sensors, software, and music with advanced neuroscience to target neural circuitry. The company is developing a pipeline of digital therapeutics across a range of neurological conditions, including stroke, multiple sclerosis and Parkinson's disease. The company's pipeline product for chronic stroke walking deficits received Breakthrough Device designation in 2020 and the company raised a Series B financing round in 2021 led by Morningside Ventures and Advantage Capital. MedRhythms is headquartered in Portland, Maine.