HAPPITUM™ LAUNCHES NATIONWIDE IN THE GI MARKET: A NATURAL, MULTIFACTORIAL APPROACH TO GUT WELLNESS
Miami, FL — 5/23/24 — Happitum™, a Gastroenterologist – formulated natural gut wellness supplement, is now available nationwide after a focused launch in the New York and Florida markets. Happitum™ offers a comprehensive approach to supporting digestive health and overall well-being for Gastroenterology patients.
Happitum™ is distributed through Gastroenterology offices and can also be purchased by patients directly from the website happitum.com. Since its launch in early 2024, the product has received an overwhelmingly positive reception amongst the GI community and patients for its natural ingredients, which support common digestive issues such as bloating, digestion, and stress.
“Our goal at Happitum™ is to provide the Gastroenterology community a natural supplement that supports gut health effectively, and can be trusted by our physician partners and consumers alike,” said Matt Kurland, Co-Founder of Happitum™. “We have combined clinically supported, natural ingredients to promote calming, along with digestive enzymes to support bloating and digestion. The multifactorial formula can benefit a variety of patients who see their Gastroenterologist in need of a product that is safe and reliable without taking any drugs. Nearly everyone has gut issues due to their diet, lifestyle, and stress in general. The ingredients in Happitum™ directly address these root causes.”
Happitum™ is GI-formulated, vegan, gluten-free, made in the USA, and undergoes rigorous third-party lab testing to ensure the highest standards of safety and efficacy. Happitum™ is formulated with a blend of bioactive natural ingredients, including:
Peppermint, Ginger, Curcumin, Artichoke Leaf: Extensively studied ingredients that promote calming of the stomach.
Alpha Galactosidase and 5-Enzyme Blend (Amylase, Protease, Lipase, Cellulase, Lactase): Supports bloating and digestion by breaking down food.
Ashwagandha and Theanine: Gut-brain axis support from ingredients that promote wellness and reduce stress.
Marshmallow Root, Slippery Elm, and Fennel Seed: Barrier protective ingredients supporting a strong digestive tract lining.
Happitum™ is committed to supporting healthcare providers in delivering the best care to their patients. We invite Gastroenterologists to become a Happitum™ Sample Partner and offer complimentary samples to their patients. Additionally, we offer QR code discounts for medical offices, as well as a wholesale program for our Physician Partners should they choose to distribute products at their office.
About Happitum™
Happitum™ is based in Miami, Florida. We are dedicated to promoting gut health through GI-formulated, natural supplements. The Happitum™ Vision is to harness the power of clinically studied, natural ingredients to support multi-factorial benefits for gut wellness, create an enhanced sense of trust between consumers and wellness benefits from their gut-balancing supplement, and create a stronger gut-health community of physicians and consumers. The Happitum™ Mission is empowering individuals to achieve digestive harmony for a healthier and balanced lifestyle.
For more information or to join one of our Partner Programs, please contact us at:
info@happitum.com
or visit: happitum.com
MORE THAN ONE-HALF OF PATIENTS WITH CROHN’S DISEASE TREATED WITH LILLY’S MIRIKIZUMAB ACHIEVED CLINICAL REMISSION AT ONE YEAR, INCLUDING PATIENTS WITH PREVIOUS BIOLOGIC FAILURE
Nearly one-half of patients on mirikizumab achieved endoscopic response at 52 weeks; most of these patients were also in clinical remission
INDIANAPOLIS, May 21, 2024 /PRNewswire/ – In Eli Lilly and Company’s (NYSE: LLY) pivotal Phase 3 VIVID-1 study, patients with moderately to severely active Crohn’s disease, with or without previous biologic failure, achieved statistically significant and clinically meaningful improvements across multiple clinical and endoscopic endpoints at one year with mirikizumab compared to placebo. Data from this study – the first Phase 3 treat-through data reported for an IL23p19 antibody – was presented at Digestive Disease Week® (DDW), held in Washington, D.C. from May 18-21.
“Crohn’s disease is a complex condition that, if untreated, may result in irreversible damage to the digestive tract. Mirikizumab patients achieved high rates of combined clinical remission and endoscopic response, two important treatment targets that are difficult to achieve in the same patient, at one year. This is particularly impressive for patients with previous biologic failure who are generally considered hard-to-treat,” said Bruce Sands, M.D., M.S., Dr. Burrill B. Crohn Professor of Medicine and Chief of the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai.* “Consistent results across patient populations underscore the potential impact of mirikizumab in individuals living with this condition.”
Crohn’s disease is a chronic, inflammatory bowel disease associated with progressive bowel damage, disability and decreased health-related quality of life. If not adequately controlled, it may lead to complications that require hospitalization and surgical intervention. A substantial proportion of patients do not experience adequate treatment outcomes, have secondary loss of response to maintenance therapy or do not tolerate existing therapies, including biologic agents. Patients with previous biologic failure may be more difficult to treat.
As previously reported, mirikizumab achieved both co-primary endpoints and all major secondary endpoints at Week 52 compared to placebo (p<0.000001), including:
Proportion of participants achieving clinical response by patient reported outcomes (PRO)** at Week 12 and clinical remission (defined as a Crohn’s Disease Activity Index [CDAI] Total Score <150) at Week 52 compared to placebo
Proportion of participants achieving clinical response by PRO at Week 12 and endoscopic response (defined as ≥50% reduction from baseline in Simple Endoscopic Score – Crohn’s Disease [SES-CD] Total Score) at Week 52 compared to placebo
Consistent response rates and treatment effects were observed in patients with no prior biologic failure (bio-naïve) and harder-to-treat patients with previous biologic failure:
39.3% of bio-naïve and 36.7% of bio-failed patients taking mirikizumab achieved composite Week 12 PRO clinical response and Week 52 endoscopic response compared to 11.8% and 6.2% of placebo, respectively
47.3% of bio-naïve and 43.4% of bio-failed patients taking mirikizumab achieved composite Week 12 PRO clinical response and Week 52 clinical remission by CDAI, compared to 26.5% and 12.4% of placebo, respectively
At one year, clinical remission and endoscopic response were achieved by 54.1% and 48.4% of patients on mirikizumab, respectively. Notably, of the patients who received mirikizumab, 56.7% of bio-naïve and 51.2% of bio-failed patients achieved clinical remission at Week 52.
Patients taking mirikizumab achieved combined Week 52 clinical remission and endoscopic response at nominally statistically significant higher rates compared to patients on ustekinumab (34.4% versus 27.9%), with greater difference among those patients with previous biologic failure. At multiple time points, including Week 52, mirikizumab also achieved nominal statistical significance compared to ustekinumab in decreasing fecal calprotectin and C-reactive protein, two key biomarkers for inflammation. Superiority to ustekinumab was not achieved for endoscopic response.
Additionally, in the population with previous biologic failure, numerically greater rates were observed with mirikizumab compared to ustekinumab for endoscopic response, endoscopic remission (SES-CD total score ≤4, a ≥2-point reduction from baseline and no subscore >1 in any individual variable), and corticosteroid-free CDAI clinical remission at Week 52. These observed differences were not statistically significant.
The overall safety profile of mirikizumab in patients with moderately to severely active Crohn’s disease was consistent with the known safety profile in patients with ulcerative colitis. The frequency of serious adverse events was greater in placebo than mirikizumab. The most common adverse events were COVID-19, anemia, arthralgia, headache, upper respiratory tract infection, nasopharyngitis and injection site reaction.
“After one year of treatment, more than one-half of patients treated with mirikizumab achieved clinical remission and nearly one-half achieved endoscopic response. Remarkably, the majority of patients who achieved either of these endpoints, achieved both together,” said Mark Genovese, M.D., senior vice president of Lilly Immunology development. “Lilly is committed to developing innovative treatments, like mirikizumab, that may improve upon the standard of care for people impacted by inflammatory bowel disease and immune-mediated diseases.”
Lilly submitted a supplemental Biologics License Application for mirikizumab in Crohn’s disease to the U.S. Food and Drug Administration and European Medicines Agency this year. Additional global regulatory submissions are planned.
Lilly is committed to finding solutions to elevate care and improve treatment outcomes for people living with inflammatory bowel diseases. Lilly has ongoing studies to evaluate the efficacy and safety of mirikizumab in other populations with Crohn’s disease, including a Phase 3 study in pediatric patients (NCT05509777) and a long-term extension study of patients with moderately to severely active Crohn’s disease (NCT04232553). Omvoh™ (mirikizumab-mrkz) is approved for the treatment of moderately to severely active ulcerative colitis (UC) in adults and has additional ongoing trials in UC, including a study in pediatric patients (NCT05784246) and a study to evaluate the long-term efficacy and safety of mirikizumab in adults (NCT03519945). Lilly is continuing to lead the science with an open-label UC trial studying two new endpoints in the assessment of bowel urgency with frequency and deferral time, both of which impact the quality of life for patients (NCT05767021).
*
Disclosure: Dr. Sands is a paid consultant for Lilly. He has not been compensated for any media work.
About the VIVID-1 Clinical Trial Program
VIVID-1 was a Phase 3, randomized, double-blind, treat-through study that evaluated the safety and efficacy of mirikizumab compared with placebo and an active control (ustekinumab) in adults with moderately to severely active Crohn’s disease. Patients randomized to mirikizumab were administered 900 mg of mirikizumab intravenously every four weeks from Week 0-12, then 300 mg subcutaneously every four weeks from Weeks 12-52. In this study, 49% of patients taking mirikizumab or placebo had experienced a prior biologic failure.
**
Clinical response by PRO is defined as ≥30% decrease in stool frequency and/or abdominal pain, and neither score worse than baseline.
Indications and Usage for Omvoh™ (mirikizumab-mrkz) (in the United States)
Omvoh™ is indicated for the treatment of moderately to severely active ulcerative colitis in adults.
Important Safety Information for Omvoh (mirikizumab-mrkz)
CONTRAINDICATIONS
Omvoh is contraindicated in patients with a history of serious hypersensitivity reaction to mirikizumab-mrkz or any of the excipients.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Serious hypersensitivity reactions, including anaphylaxis during intravenous infusion, have been reported with Omvoh administration. Infusion-related hypersensitivity reactions, including mucocutaneous erythema and pruritus, were reported during induction. If a severe hypersensitivity reaction occurs, discontinue Omvoh immediately and initiate appropriate treatment.
Infections
Omvoh may increase the risk of infection. Do not initiate treatment with Omvoh in patients with a clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing Omvoh. Instruct patients to seek medical advice if signs or symptoms of clinically important acute or chronic infection occur. If a serious infection develops or an infection is not responding to standard therapy, monitor the patient closely and do not administer Omvoh until the infection resolves.
Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Omvoh. Do not administer Omvoh to patients with active TB infection. Initiate treatment of latent TB prior to administering Omvoh. Consider anti-TB therapy prior to initiation of Omvoh in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after Omvoh treatment. In clinical trials, subjects were excluded if they had evidence of active TB, a history of active TB, or were diagnosed with latent TB at screening.
Hepatotoxicity
Drug-induced liver injury in conjunction with pruritus was reported in a clinical trial patient following a longer than recommended induction regimen. Omvoh was discontinued. Liver test abnormalities eventually returned to baseline. Evaluate liver enzymes and bilirubin at baseline and for at least 24 weeks of treatment. Monitor thereafter according to routine patient management. Consider other treatment options in patients with evidence of liver cirrhosis. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct patients to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction.
Immunizations
Avoid use of live vaccines in patients treated with Omvoh. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating therapy, complete all age-appropriate vaccinations according to current immunization guidelines. No data are available on the response to live or non-live vaccines in patients treated with Omvoh.
ADVERSE REACTIONS
Most common adverse reactions (≥2%) associated with Omvoh treatment are upper respiratory tract infections and arthralgia during induction, and upper respiratory tract infections, injection site reactions, arthralgia, rash, headache, and herpes viral infection during maintenance.
NEW MULTILINGUAL TOOL, SPEECHMED+GI, REVOLUTIONIZES COLONOSCOPY PREPARATION AND ENHANCES COLON CANCER SCREENING EFFORTS
Enhancing Colonoscopy Prep with Technology: SpeechMED+GI Supports Early Detection and Expands Access in High-Risk Communities
MIAMI, Florida (June 13, 2024) – SpeechMED™, a pioneer in health literacy solutions, is excited to announce the launch of SpeechMED+GI, a groundbreaking multilingual audio tool designed to significantly improve the preparation process for colonoscopies. This innovative platform is tailored to not only streamline pre-procedure instructions but also to bolster colon cancer screening efforts, particularly in underserved communities with historically low screening rates but high risks of colon cancer.
SpeechMED+GI enhances the traditional patient preparation experience by replacing outdated paper-based instructions with an adaptive, user-friendly mobile app that communicates in the patient’s native language. This approach ensures that patients fully understand their pre-procedure requirements, which is crucial for effective screening and early detection of colon cancer.
Key Features and Community Impact:
Enhanced Accessibility: Multilingual capabilities make vital pre-procedure information accessible to diverse patient populations, promoting higher screening rates among communities at increased risk of colon cancer.
Improved Compliance and Understanding: Gastroenterologists have reported that despite distributing pre-procedure instructions, many patients arrive unprepared, often unaware of dietary restrictions essential for a successful colonoscopy. SpeechMED+GI addresses this gap by providing clear, engaging instructions with reminders that patients can easily follow.
Supporting Gastroenterologists: Amidst a growing shortage of gastroenterology specialists, SpeechMED+GI helps maximize the efficiency of existing providers by reducing the number of repeat procedures and patient no-shows due to inadequate preparation.
Benefits for Colonoscopy Facilities:
Reduce Inadequate Prep Rates: SpeechMED+GI addresses the common issue of inadequate bowel preparation, which can lead to repeated procedures, wasted resources, and increased healthcare costs.
Enhanced Patient Adherence: Patients can easily switch the instructions in multiple languages and with information presented in an easy-to-understand format, SpeechMED+GI significantly boosts patient compliance.
Improved Detection Rates: Proper preparation improves visibility during colonoscopies, increasing the likelihood of detecting anomalies at an early stage.
“Our commitment at SpeechMED is to bridge the communication gap in healthcare,” says Susan Perry, CEO of SpeechMED. “SpeechMED+GI is specifically designed to ensure that all patients, regardless of their language skills or literacy level, receive the best possible preparation for colonoscopies. We are proud to offer a tool that not only enhances patient experience but also supports the critical work of gastroenterologists.”
SpeechMED+GI expands on SpeechMED’s proven platform, which facilitates communication by allowing patients to receive medical instructions in their preferred language, both verbally and visually.
SpeechMED+GI is now available and can be integrated into healthcare systems immediately. Demonstrations and more detailed information about the product are available upon request by contacting GI@SpeechMED.com.
About SpeechMED
Taylannas, Inc. is a minority woman-owned and women-led health tech company on a mission of inclusion to make healthcare information understandable to everyone regardless of their language, vision, or ability to read. Their award-winning SpeechMED™ language and audio patient engagement platform is available for enterprise and personal use.
Learn more at:
speechmed.com