September 25, 2019 07:30 ET | Source: Aerami Therapeutics
Aerami is exploring inhaled therapies beyond human insulin in multiple chronic conditions
Launched three new pipeline programs aimed at treatment of type 2 diabetes, hypoparathyroidism and human growth hormone deficiency
Plans to advance an inhalable fast acting GLP-1 receptor agonist into clinic in 2020
DURHAM, N.C., Sept. 25, 2019 (GLOBE NEWSWIRE) — Dance Biopharm, a clinical-stage company reimagining the treatment of chronic diseases with inhaled therapies, today announced it is rebranding as Aerami Therapeutics and moving its headquarters to Durham, North Carolina. The new brand, which will be implemented immediately, comes as the company pursues strategic partners for its lead asset, Dance 501 inhaled human insulin, to progress into pivotal registration studies, and expands its pipeline to include inhaled therapeutics for endocrinology diseases – designed to provide patients an alternative to routine injectable treatments.
The new brand better reflects the Company’s broadened focus beyond diabetes to include additional chronic conditions that could potentially achieve better treatment efficiency from the patient friendly administration afforded by Aerami’s gentle mist, smart inhaler. Aerami plans to advance new pipeline programs in hypoparathyroidism and human growth hormone (HGH) deficiency in addition to its existing inhalable GLP-1 receptor agonist candidate. Each of these programs could enter clinical development in 2020, subject to our ability to obtain additional funding.
“We are proud to launch Aerami, which is derived from a combination of Greek and Latin words. ’Aero’ means air/wind and ’ami’ means friend/friendly. The new brand reflects our commitment to provide patients living with chronic diseases, a patient-friendly alternative to routine injections, with our gentle mist inhaler,” said Anne Whitaker, chief executive officer of Aerami Therapeutics. “Our initial focus going forward is on rare and severe diseases in the endocrinology, respiratory and cardiovascular space. We have launched new pipeline programs in hypoparathyroidism and human growth hormone deficiency, which could benefit from the frequent pulsatile administration of inhaled parathyroid hormone and HGH, respectively, afforded by our smart inhaler. In addition, we are targeting advancing our inhalable pre-meal GLP-1 receptor agonist into the clinic in 2020, subject to additional funding, for treatment of type 2 diabetes patients who are not meeting their HbA1c goals with their current oral anti-diabetic treatments.”
About Aerami Therapeutics
Aerami Therapeutics is a clinical-stage company reimagining the treatment of chronic diseases with inhaled therapies. The Company’s gentle mist inhaler is designed with smart technology to optimize the precise delivery of biologic therapies through the lungs. In addition to its Phase 3-ready inhaled insulin product Dance-501, Aerami is building a diverse pipeline of inhaled therapies with an initial focus on rare and severe diseases in the endocrinology, respiratory and cardiovascular space, where its platform and expertise present a unique opportunity to achieve better treatment efficiency and patient experience. Aerami has initiated development programs for inhaled glucagon-like peptide-1 (GLP-1) for the treatment of type 2 diabetes, inhaled parathyroid hormone (PTH) for the treatment of hypoparathyroidism and inhaled human growth hormone (HGH) for the treatment of HGH deficiency.
September 19, 2019 08:30 ET | Source: Dance Biopharm
Data demonstrated earlier onset of action and higher early effect of Dance 501 inhaled insulin compared to injected insulin lispro in patients with type 2 diabetes
Validated smart inhaler delivers optimal and precise doses of inhaled therapy through the lungs with good tolerability
DURHAM, N.C., Sept. 19, 2019 (GLOBE NEWSWIRE) — Dance Biopharm Holdings, Inc., a clinical-stage company reimagining the treatment of chronic diseases with inhaled therapies, today presented data from its Phase 2 clinical study of Dance 501, a novel gentle mist formulation of human insulin administered with its smart inhaler, in patients with type 2 diabetes (T2D). The data were presented at the 55th Annual Meeting of the European Association for the Study of Diabetes on September 19, 2019, in Barcelona, Spain. Study results showed Dance 501 inhaled human insulin (INH) had comparable glucodynamic properties to injected insulin lispro (LIS), but delivered a faster onset of action.
“These encouraging study results demonstrate the potential of Dance 501 INH to offer a clinically meaningful benefit over rapid-acting insulin injections for patients with type 2 diabetes, while also providing a more comfortable patient experience,” said Melissa Rhodes, Ph.D., chief development officer of Dance Biopharm. “This study also further validates our smart inhaler’s ability to deliver an optimal and precise dose of inhaled therapies through the lungs. A number of diseases could benefit from the frequent pulsatile administration afforded by an inhaled delivery option, so we are exploring inhaled therapies beyond human insulin where our platform could achieve better treatment efficiency.”
“Dance 501 inhaled human insulin demonstrated faster onset and greater action in the first hour of administration compared to subcutaneous insulin lispro, with good tolerability in patients with type 2 diabetes,” said Eric Zijlstra, Ph.D., lead study author and presenter. “Not only does this allow for Dance 501 INH to be administered shortly before meals, but the ease of use could potentially motivate more patients to better comply with standard medical guidance.”
Trial Design and Results
The randomized, controlled clinical study evaluated the pharmacodynamic action and safety of Dance 501 inhaled human insulin in comparison to injected insulin lispro in T2D patients. The study enrolled 24 subjects with type 2 diabetes on daily insulin therapy. Each patient received three doses 12, 24 and 48 U of Dance 501 (assuming a 13% relative biopotency) and subcutaneous insulin lispro. Patients received a total of six doses, administered over six visit that occurred 3 to 17 days apart. Insulin action was measured using the automated glucose clamp method over a 10-hour period following dosing.
Key findings from the clinical trial:
Dance 501 showed comparable pharmacodynamic properties and more rapid onset of action compared to insulin lispro, with median differences of 6.5 to 20 min, p<0.02.
Dance 501 showed greater action in the first hour of administration to lispro at all three doses with median relative differences of 45% to 107%, p < 0.05.
Time to maximum insulin action was comparable for each dose level.
No safety issues, cough or acute changes in lung function were observed with any inhalation.
About Dance Biopharm
Dance Biopharm is a clinical-stage company reimagining the treatment of chronic diseases with inhaled therapies. Our gentle mist inhaler is designed with smart technology to optimize the precise delivery of biologic therapies through the lungs. We are building a diverse pipeline of inhaled biologic products with initial focus on rare and severe diseases in the endocrinology, respiratory and cardiovascular space, where our platform and expertise present a unique opportunity to achieve better treatment efficiency. We have initiated development programs in glucagon-like peptide-1 (GLP-1), parathyroid hormone (PTH) and human growth hormone (HGH). For more information, visit: https://www.dancebiopharm.com.
Dance Biopharm signs an agreement with DarioHealth to integrate Dance’s gentle mist smart inhaler into DarioHealth’s platform allowing for automated, real-time treatment data through a mobile application
Combined platforms have potential to improve patient engagement and compliance
DURHAM, North Carolina and NEW YORK, Sept. 11, 2019 /PRNewswire/ — Dance Biopharm Holdings, Inc., a clinical-stage company reimagining the treatment of chronic diseases with inhaled therapies, announced today it has formed a strategic alliance with DarioHealth Corp. “Dario” (Nasdaq: DRIO), a leading, global digital therapeutics company, to expand access to a personalized digital health management platform for patients with chronic diseases. Under the terms of the agreement, Dance Biopharm will integrate its gentle mist smart inhaler into DarioHealth’s digital therapeutics platform to provide patients automated, real-time treatment data through an advanced mobile application. Dario will immediately start the design of the integrated solution for Dance to accommodate clinical trials and, upon regulatory approval, any marketed solutions.
Dance Biopharm’s smart inhaler paired with proprietary gentle mist biologic formulations allows for optimal and precise delivery of therapies through the lungs. The vibrating mesh within the device facilitates the transmission of a soft mist that allows for a lung deposition 2-4 times higher than conventional inhalers. In clinical trials, the device delivered a gentle mist formulation of human insulin with a faster drug onset and comparable duration to subcutaneous delivery of a rapid insulin (Humalog) in patients with type 2 diabetes (T2D). Dance is also advancing a convenient inhalable pre-meal GLP-1 receptor agonist to improve postprandial glucose control in T2D patients.
Dario’s digital therapeutics platform combines data analytics, high-quality software and personalized coaching to empower individuals with information to make healthy behavioral changes. The user-centric platform is comprised of MyDario™, a mobile application that is data-driven, with an all-in-one blood glucose monitoring system and an optional connected blood pressure monitoring system. It is complemented by DarioEngage™, a healthcare solutions platform for health and wellness providers to customize and integrate a patient’s data into their care continuum.
“We are excited to partner with DarioHealth in empowering patients to take charge of their chronic illness. This platform is well established in the digital therapeutics space and has demonstrated positive behavior change in patients with chronic diseases through its user-centered approach,” said Anne Whitaker, chief executive officer of Dance Biopharm. “We share a similar goal of adapting our platforms to chronic diseases beyond diabetes. Dance Biopharm is exploring opportunities to pair the smart inhaler with gentle mist biologic formulations beyond insulin. Our initial focus is on rare and severe diseases in the endocrinology, respiratory, and cardiovascular space, where our platform and expertise present a unique opportunity to achieve better treatment efficiency.”
“Diabetes is a complex chronic condition that evolves over time, making real-time, streamed patient data essential to care,” said Erez Raphael, chief executive officer of DarioHealth. “Through this strategic alliance, we are excited to expand the potential for our patient-centered, diabetes care and management solutions by integrating the smart inhaler, optimized to deliver a gentle mist formulation of insulin through the lungs, into our digital therapeutics platform, which includes blood glucose and blood pressure monitoring systems. Our goal is to place control of diabetes management directly into the hands of our users and, pending completion of clinical trials and regulatory approval, we believe that this alliance will help advance that critical objective.”
About Dance Biopharm
Dance Biopharm is a clinical-stage company reimagining the treatment of chronic diseases with inhaled therapies. Our gentle mist inhaler is designed with smart technology to optimize the precise delivery of biologic therapies through the lungs. We are building a diverse pipeline of inhaled biologic products with initial focus on rare and severe diseases in the endocrinology, respiratory and cardiovascular space, where our platform and expertise present a unique opportunity to achieve better treatment efficiency. We have initiated development programs in glucagon-like peptide-1 (GLP-1), parathyroid hormone (PTH) and human growth hormone (HGH).
DarioHealth Corp. (Nasdaq: DRIO) is a leading, global digital therapeutics company revolutionizing the way people with chronic conditions manage their health. By delivering evidence-based interventions that are driven by data, high-quality software and coaching, we empower individuals to make healthy adjustments to their daily lifestyle choices to improve their overall health. Our cross-functional team operates at the intersection of life sciences, behavioral science and software technology to deliver highly engaging therapeutic interventions. Dario is one of the highest-rated diabetes solutions in the market, and its user-centric MyDario™ mobile app is loved by tens of thousands of consumers around the globe. DarioHealth is rapidly moving into new chronic conditions and geographic markets, using a performance-based approach to improve the health of users managing chronic disease. To learn more about DarioHealth and its digital health solutions, please go to: http://mydario.com/
This news release and the statements of representatives and partners of DarioHealth Corp. (the “Company”) related thereto contain or may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “plan,” “project,” “potential,” “seek,” “may,” “will,” “expect,” “believe,” “anticipate,” “intend,” “could,” “estimate,” or “continue” are intended to identify forward-looking statements. For example, when the Company discusses the integration of Dance Biopharm’s gentle mist inhaler with its digital platform, that Dario will immediately start the design of the integrated solution for Dance to accommodate clinical trials and, upon regulatory approval, any marketed solutions and the belief that Dario’s alliance with Dance, pending completion of clinical trials and regulatory approval, will help advance the critical objective of placing control of diabetes management directly into the hands of its users, it is using forward-looking statements. Readers are cautioned that certain important factors may affect the Company’s actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release. Factors that may affect the Company’s results include, but are not limited to, regulatory approvals, product demand, market acceptance, impact of competitive products and prices, product development, commercialization or technological difficulties, the success or failure of negotiations and trade, legal, social and economic risks, and the risks associated with the adequacy of existing cash resources. Additional factors that could cause or contribute to differences between the Company’s actual results and forward-looking statements include, but are not limited to, those risks discussed in the Company’s filings with the U.S. Securities and Exchange Commission. Readers are cautioned that actual results (including, without limitation, the timing for and results of the Company’s commercial and regulatory plans for Dario) may differ significantly from those set forth in the forward-looking statements. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
– This trial, conducted in patients with type 2 diabetes, compared three doses each of Dance 501 inhaled insulin and subcutaneous insulin lispro –
SAN FRANCISCO–(BUSINESS WIRE)– Dance Biopharm Holdings, Inc., a privately-held clinical stage biopharma company focused on the development of novel soft mist inhalable formulations of biologics for people living with chronic diseases, today announced presentations of Phase 2 clinical trial results for its inhaled preservative-free human insulin, Dance 501, for the treatment of diabetes. The data will be presented at the 79th Scientific Sessions of the American Diabetes Association (#ADA2019), which will be held June 7-11, 2019 at the Moscone Center in San Francisco.
Details of the poster presentations are as follows:
Title: Dance 501 Inhaled Human Insulin (INH): Linear Dose Response, Earlier Onset of Action, and Higher Early Effect than s.c. Insulin Lispro (LIS) Abstract: Control #2019-A-5548-Diabetes Poster Board: 1085-P in category 12-E Clinical Therapeutics/New Technology–Insulins Presenter: Eric Zijlstra, Ph.D. Presentation Details: Session Type: General Poster Session Session Title: Saturday General Poster Session Session Date/Time: Saturday June 8, 2019 11:30 a.m. – 12:30 p.m. PT Location: Poster Hall (Hall F, North, Exhibition Level)
Session Type: ePoster Theater Session Title: Newest Insulins Session Date/Time: Sunday June 9, 2019 12:00 p.m. – 1:00 p.m. PT Location: Exhibit Hall (ePoster Theater B)
About Dance Biopharm
Dance Biopharm is a private company focused on developing novel inhaled formulations of biologics to treat severe and chronic diseases. The company’s novel inhalation delivery technology platform may be utilized with liquid formulations of biologics with the goal of providing effective and convenient treatment options to patients along with wireless connectivity to improve disease management. Dance, headquartered in the San Francisco Bay Area, was founded by John Patton, Ph.D., who has over 25 years of experience developing numerous inhaled therapies. For more information, please visit http://dancebiopharm.com.
FORWARD-LOOKING STATEMENTS
All statements other than statements of historical fact included in this press release are forward-looking statements that are subject to certain risks, trends and uncertainties that could cause actual results and achievements to differ materially from those expressed in such statements. We have based these forward-looking statements upon information available to management of Dance as of the date of this release and management’s expectations and projections about certain future events. It is possible that the assumptions made by management for purposes of such statements may not materialize. Actual results may differ materially from those projected or implied in any forward-looking statements. Such statements may involve risks and uncertainties, including but not limited to those relating to our limited operating history, our ability to successfully develop product candidates, including Dance 501, the cost and uncertainty of obtaining regulatory approvals, our ability to bring product candidates, including Dance 501, to multiple markets and our ability to develop inhaled formulations of other medicines.
