Altavant Sciences Initiates Phase 2a Study of Rodatristat Ethyl in Pulmonary Arterial Hypertension - BioSpace
Altavant Sciences Initiates Phase 2a Study of Rodatristat Ethyl in Pulmonary Arterial Hypertension - BioSpace |
- Altavant Sciences Initiates Phase 2a Study of Rodatristat Ethyl in Pulmonary Arterial Hypertension - BioSpace
- PH-ILD Trial's Second Patient Group Is Enrolled to Test INOpulse Therapy - Pulmonary Hypertension News
- Dangerous elevations | Front Features - High Plains Journal
| Posted: 05 Aug 2019 04:45 AM PDT | | CARY, N.C. and BASEL, Switzerland, Aug. 5, 2019 /PRNewswire/ -- Altavant Sciences, a clinical-stage biopharmaceutical company focused on patient-centric drug development in rare respiratory diseases, announced that it has dosed the first patient in the ELEVATE 1 proof-of-concept Phase 2a study of the company's lead candidate, rodatristat ethyl, in patients with pulmonary arterial hypertension (PAH). The study is designed to provide valuable safety, target engagement and biomarker information, which will be used to inform a comprehensive Phase 2b efficacy study of rodatristat ethyl in PAH. "Initiating the ELEVATE 1 Study is a significant milestone for Altavant, and represents our commitment to the rare respiratory disease community and our approach to patient-centric, transparent clinical development," said William T. Symonds, Pharm.D., Chief Executive Officer of Altavant. "Rodatristat ethyl is a first-in-class investigational medicine for the treatment of PAH. Our goal for ELEVATE 1 is to establish proof-of-concept for this new mechanism in PAH, which we believe could halt or reverse the pulmonary vascular remodeling characteristic of the disease. Success in this study would take us one step closer to being able to provide a much-needed, new therapeutic option to PAH patients." Marc Humbert, M.D., Ph.D., Professor of Respiratory Medicine at the South Paris University (Université Paris-Saclay), Director of the French Pulmonary Hypertension Reference Center, and member of Altavant's Scientific Advisory Board, added, "While the introduction of vasodilators was a significant advancement in treating PAH, having improved exercise capacity, hemodynamics and quality of life for countless patients, there is still a need to develop novel treatment options to further improve lifespan. New R&D efforts, such as those pursued at Altavant, may ultimately give us an opportunity to offer a new treatment option to PAH patients that provides better outcomes. I'm excited to help further that R&D effort and elevate the conversation about PAH and the need for new therapies within the medical community." About the ELEVATE 1 Study About Rodatristat Ethyl About Altavant Sciences About Roivant Pharma About Roivant Sciences Contact:
SOURCE Altavant Sciences |  |
| Posted: 05 Aug 2019 08:00 AM PDT Bellerophon reached its enrollment goal for the second group of patients in its ongoing Phase 2/3 trial evaluating different doses of INOpulse therapy for pulmonary hypertension associated with interstitial lung disease (PH-ILD), a illness for which no treatments exist. PH-ILD patients in group (or cohort) 2 will test a higher dose — 45 mcg/kg ideal body weight (IBW) per hour — of inhaled nitric oxide (iNO, which is a potent vasodilator that relaxes blood vessels) and for a longer 16-week period than the first cohort of patients who experienced meaningful improvements with a lower dose (30 mcg/kg ideal body weight per hour). The optimal dose identified from these studies will be used in a subsequent Phase 3 part, which is necessary for Bellerophon to apply for INOpulse's approval. This last phase is expected to start in the first quarter of 2020. "We have been extremely pleased with the rate of enrollment in cohort 2, and are thankful for the continued support and enthusiasm from our sites. We look forward to study completion by year-end 2019," Fabian Tenenbaum, Bellerophon's CEO, said in a news release. In January, results from the first group of patients (cohort 1, with 41 patients) in the clinical trial (NCT03267108) demonstrated that an eight-week treatment with the lowest dose of iNO (30 mcg/kg IBW/hr) is safe, and produces clinically meaningful improvements in moderate to vigorous physical activity, or MVPA, as well as other physical activity parameters. This dose of iNO, delivered through INOpulse, made it easier to walk, climb stairs, or do yardwork in 23% of the patients, compared with no improvements observed in these parameters in the placebo group. Bellerophon has now reached its target enrollment of 44 subjects for cohort 2. In this group, patients will be randomized to a higher dose of iNO45 (45 mcg/kg IBW/hr) or a placebo, over 16 weeks. Subjects can then proceed to a long-term open-label study. Cohort 3 includes the larger and pivotal Phase 3 part, which is hoped to provide key data to allow Bellerophon to request INOpulse's approval. It is expected to enrol about 300 subjects who will be randomly and blindly assigned to either iNO or a placebo for 16 weeks. MVPA will be the primary efficacy measure, or endpoint, as recently agreed upon between Bellerophon and the U.S. Food and Drug Administration. "PH-ILD is a debilitating and life threatening disease where patients suffer severe functional impairment that limit their capacity to perform even the most basic daily tasks," Tenenbaum said. "The capability of INOpulse to improve MVPA would directly benefit a patient's ability to function, and provides the potential for the first approved therapy in this unmet medical need."  | |||
| Dangerous elevations | Front Features - High Plains Journal Posted: 05 Aug 2019 06:00 AM PDT When you visit the mountains, you anticipate the thinner air that causes your breathing to become labored and your head to spin a little. What you're feeling is the affects of hypoxia, or a lack of oxygen. Hypoxia brings on pulmonary vascular shunting, which is your body's way of moving blood around in your lungs searching for an area with more oxygen. Humans eventually feel better as their body adjusts to the conditions or when they return to lower elevations. Every person will experience these same symptoms, but for cattle there is no recovery. Cattle are known as exaggerated responders to elevation change. Their bodies cannot make the necessary adjustments and High Mountain Disease, also known as brisket disease, advances with fatal results. According to Dr. Tim Holt, associate professor at Colorado State University's Veterinary Teaching Hospital, HMD causes pulmonary vessels in the cattle's lungs to become so small, sometimes to the point of complete obliteration, that the body increases the amount of blood pushed out by the heart. With this drastic tightening of the blood vessels, pulmonary hypertension develops. This type of hypertension eventually brings on congestive right heart failure with death not far behind. No vaccination or supplement can be given to prevent HMD. Holt says the best way to determine if an animal will respond adversely to higher elevations is through a Pulmonary Arterial Pressure test. A PAP test tries to predict the degree of pulmonary hypertension in relation to the exaggerated shunting taking place.  By Scott Strickland, Westwood, Kansas. Holt performs the test by running a catheter down in the pulmonary artery to measure the pressure within, using millimeters of mercury, or mmHg, measurement units. Human blood pressure is measured in the same way just using an external monitor. "A normal PAP test in elevation is most commonly below 41mmHg," Holt said. "Pressures about 50mmHg are considered elevated and are indicative of a possible heritable trait leading to the exaggerated response to hypoxia." Animals with a 50mmHg measurement are more likely to die due to the condition. Holt uses test results to help ranchers make decisions by genetically selecting resistant animals. Who should test their cattle? Those genetically resistant animals are the backbone of ranchers in the higher elevations. No matter your current elevation, PAP tests are a good investment if you have aspirations of being a seedstock producer and want to sell your animals to any and all buyers. This information will give buyers confidence that your stock can survive the environment at their new home. Seed stock producers are Holt's main customers for PAP testing, but commercial producers should be aware too. "The losses (from HMD) can be devastating, ranging from 5 to 27% percent calf loss per year." Angus Genetics Inc. launched a research expected progeny difference for HMD earlier this year. With Colorado State University, the American Angus Association and AGI, Holt assisted in the development an EPD that will help producers identify cattle less susceptible to HMD. According to a press release distributed by AGI, the EPD will identify low-risk genetics to be used as parents for the next generation. Kelli Retallick, AGI director of genetic service, cautions that the EPD will not replace individual PAP tests for animals living at altitude. "If we send a calf that does not PAP well up to high altitude, it could now be a life or death situation," Retallick said. "This is probably one of the most important traits that we need to think about from a phenotypic standpoint. Relate it to something like scrotal size and scrotal EPD for instance. In this case, an animal can have the genetics to produce larger scrotal sizes as indicated by the EPD, but the scrotal EPD does not replace breeding soundness exams." A cautious program Anne Nielsen, Saguache, Colorado, has implemented PAP testing for the last 15 years. At 12,000-feet elevation, her family's Flying X Cattle Company tests every bull they use on their Angus herd. "We bring several out at a time," she said, then if the bulls test in the high range they get sent back with the knowledge that they are only suitable to be used in the immediate area of where they were raised. The Nielsens don't stop with just the bulls either. "We just tested 150 calves and 12% came back susceptible," she said. Nielsen said she has had bunches test as high as 30 to 40%. The Flying X works with Holt to test calves that are six weeks to three months old each spring and fall. Holt cautions producers not to single out one side or the other. "This is not a gene that is just carried by the male, it can be female related as well," Holt said. A shifting line When Holt started PAP testing years ago, he had never seen HMD below 7,000 feet. While Holt and his colleagues aren't sure it is the exact same disease, they have seen similar symptoms in feedlots below 5,000 feet. "Now as we have changed our genetics, we have changed our breeding, we've changed our husbandry or we've changed our feedlot status," he said, "we're seeing it at lower elevations." Jennifer Theurer can be reached at 620-227-1858 or jtheurer@hpj.com.  |
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