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EVOK $6.17 800k small floater
Compelling Data Unveiled at American College of Gastroenterology 2024 Meeting in OctoberPresented posters with data showing statistically significant improvement in patient outcomes for GLP-1 users with diabetic gastroparesis while taking GIMOTI.Poster won the Presidential Poster Award as one of the top 5% of data accepted by the conference and also selected as the Outstanding Research Award in the Stomach Category.
Robust Balance Sheet with Extended Runway As of September 30, the Company had cash and cash equivalents of approximately $11.3 million which includes approximately $10.8 million from warrant exercise financing activities through 3Q 2024.In October 2024, the Company also raised approximately $3.5 million through the exercise of warrants by existing investors.The Company anticipates its current cash on hand will fund its operations into the fourth quarter of 2025.Based on net sales generated in the first three quarters of 2024, Evoke is revising its 2024 guidance to $9.5-10.0 million from a range of $11- 12 million, still reflecting almost a doubling from the previous year, if achieved. Evoke’s 2024 guidance is dependent on its current business and expectations, including recent growth rates in net sales, assumptions regarding reimbursements and prescription fills, as well as factors that are outside of our control, such as the global macroeconomic and geopolitical environment, continued supply chain constraints and inflationary pressures.About Evoke Pharma, Inc.Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The company developed, commercialized and markets GIMOTI, a nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults.Diabetic gastroparesis is a GI disorder affecting millions of patients worldwide, in which the stomach takes too long to empty its contents resulting in serious GI symptoms as well as other systemic complications. The gastric delay caused by gastroparesis can compromise absorption of orally administered medications. Prior to FDA approval to commercially market GIMOTI, metoclopramide was only available in oral and injectable formulations and remains the only drug currently approved in the United States to treat gastroparesis.
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Hey bro the News is outstanding! voke Pharma & EVERSANA Announce Statistically Significant Improvement in Patient Outcomes for GLP-1 users with Diabetic Gastroparesis using GIMOTI®
Analysis of real-world data compared patients on GIMOTI (n=51) to Oral Metoclopramide (n=41), both taking GLP-1s, showing significant statistical improvement for GIMOTI over Oral Metoclopramide in All Cause Emergency Department Visits (-91%, p=0.001), All Cause Office Visits (-41%, p=0.027) and All Cause Hospital Outpatient Visits (-89%, p=0.032) within 6-month index period
Data presented at American College of Gastroenterology (ACG) 2024; the submission garnered both the Presidential Poster Award as one of the top 5% of data accepted to the conference and selected as the Outstanding Research Award in the Stomach Category
First study to show Gimoti’s potential as supportive care for GLP-1 therapy
SOLANA BEACH, Calif., Oct. 28, 2024 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on developing treatments for gastrointestinal (GI) diseases, with a particular emphasis on GIMOTI® (metoclopramide) nasal spray, together with EVERSANA, a leading provider of global commercial services to the life sciences industry, today announced the presentation of data for GLP-1 users with diabetic gastroparesis using GIMOTI at the American College of Gastroenterology (ACG) 2024 Annual Meeting.
The real-world retrospective study evaluated the impact of GIMOTI (metoclopramide nasal spray) in patients with diabetic gastroparesis (DGP) who were concurrently using GLP-1 receptor agonists. GLP-1 drugs are commonly prescribed for type 2 diabetes, and with the approval of GLP-1 medications, there have been increasing reports of these drugs exacerbating GI symptoms, specifically gastroparesis. GLP-1 medications function, in part, by causing delayed gastric emptying. Delayed gastric emptying, in the absence of mechanical obstruction, is the definition of gastroparesis. In a recent National Institute of Health (NIH) study (https://pubmed.ncbi.nlm.nih.gov/38399414/), an estimated 5.1% of patients in their study (n=10,328) on GLP-1 medications had gastroparesis.
The GIMOTI study compared healthcare resource utilization (HRU) between patients using GIMOTI nasal metoclopramide (NMCP) and those on oral metoclopramide (OMCP), specifically focusing on individuals with a prior GLP-1 prescription. Significant reductions across a collection of outcomes were observed in patients treated with GIMOTI versus oral metoclopramide.
Key Study Findings Presented at ACG 2024:
Patients with prior GLP-1 history had reduced HRU after taking NMCP In NMCP patients, all-cause emergency department (ED) visits decreased by 55% (mean [SD]: 0.25 [1.13] post-index vs. 0.55 [1.30] pre-index; p=0.063); andDGP-related ED visits decreased by 28% (mean [SD]: 0.18 [0.99] post-index vs. 0.25 [1.28] pre-index; p=0.203).
In patients taking GLP-1, those that took NMCP had fewer healthcare visits compared to those taking OMCP All-cause and DGP-related ED visits were 91% lower (cIRR: 0.09, 95% CI: 0.01, 0.42; p=0.001) and 89% lower (cIRR: 0.11, 95% CI: 0, 0.93; p=0.046) for NMCP vs. OMCP; andAll-cause Hospital Outpatient visits were 89% lower (cIRR = 0.11, 95% CI: 0.01, 0.73; p = 0.032)All-cause and DGP-related office visits were 41% lower (cIRR: 0.59, 95% CI: 0.37, 0.94; p=0.027) and 66% lower (cIRR: 0.34, 95% CI: 0.017, 0.65; p=0.001) for NMCP vs. OMCP.
NMCP can be used to effectively treat patients with gastroparesis taking GLP-1 treatment and avoid costly healthcare visits All-cause clinic, outpatient, and inpatient visits showed similar trends favoring NMCP vs. OMCP.In DGP patients with a prior claim for GLP-1, NMCP use was associated with numerically and significantly reduced all-cause and DGP-related HRU compared to pre-treatment utilization and OMCP-treated controls.
https://ml.globenewswire.com/Resource/Download/cfc46127-a976-498b-8e19-d5c879171b81/comparison-of-healthcare-resource-utilization-in-glp-1-agonist-patients-with-dgp.png
"This data is particularly encouraging given the rising number of patients using GLP-1 agonists for diabetes, many of whom also suffer from gastroparesis," said Matt D’Onofrio, CEO of Evoke Pharma. "Our goal is to provide data regarding Gimoti as supportive care for diabetic gastroparesis for those also on GLP-1 agonists. This study, combined with the earlier real-world data presented at key conferences, reinforces GIMOTI's potential to improve outcomes for patients and reduce the overall financial burden on the healthcare system."
The study's specific cohort consisted of 92 total patients between the nasal metoclopramide (NMCP, N=51) and oral metoclopramide (OMCP, N=41) groups. The NMCP group had a slightly older average age (55.1 years) compared to the OMCP group (53.1 years). A notable portion of the NMCP group (31.4%) had experienced hospitalizations or emergency department visits before treatment, compared to 19.5% in the OMCP group.
In a separate study, a post-hoc analysis focused on safety data for a female subgroup from a previous Phase 3 study that included 36 women using GLP-1 drugs during the 28-day study. Among these, 13 were treated with GIMOTI and 23 with placebo. The majority (94%) of the participants completed the study, with no serious adverse events reported in either group. This analysis indicated no series safety issues and a trend toward nausea improvement when GLP-1 drugs were used with NMCP.
"Our continued focus is helping patients that have gastroparesis and diabetes. The fact that up to 20 million patients (KFF Health Tracking Poll (April 23-May 1, 2024) (kff.org/KFF Health Tracking Poll)) may have taken or are currently taking GLP-1s for their diabetes, indicates this is an important patient constituency the medical community needs to monitor and address," said Chris Quesenberry, Chief Commercial Officer of Gimoti. "Evoke Pharma, through its clinical development program and real-world evidence studies, is uniquely positioned to provide clinicians with information that may inform treatment decisions. This study provides insight that clinicians who treated their patients with diabetic gastroparesis, who were also taking a GLP-1, benefitted in taking GIMOTI®, an innovative, non-oral therapy that does not rely on a dysfunctional gut to work."
The results presented at ACG 2024 build on a growing body of real-world data that underscores GIMOTI's ability to significantly reduce HRU in patients with diabetic gastroparesis. Earlier studies presented at Digestive Disease Week (DDW) 2024 and ACG 2023 demonstrated that patients treated with GIMOTI showed fewer hospitalizations, emergency department visits, and physician office visits compared to those using oral metoclopramide. Also, these studies highlighted that GIMOTI reduced healthcare costs by over $15,000 per patient in a six-month period compared to oral metoclopramide??.
"These studies further confirm the important role of GIMOTI in managing diabetic gastroparesis and supports its use for patients concurrently on GLP-1 agonists," said Dr. Michael Cline, Medical Director of the Gastroparesis Clinic at Cleveland Clinic, an author of the study. "In my practice, I’ve treated patients arriving with gastroparesis while on a GLP-1. This data demonstrates a significant reduction in emergency room visits, office visits, and overall healthcare resource utilization, which not only improves patient outcomes but also reduces the strain on healthcare systems. The nasal delivery of metoclopramide offers a distinct advantage for patients with delayed gastric emptying, ensuring they receive the relief they need without the complications or unknown absorption associated with oral medications."
EVERSANA was named Evoke’s commercialization partner to support commercialization efforts of GIMOTI, first in 2020 and then an extended partnership was announced in February 2022.
Slides referencing data to the studies can be found under news and presentations of the Evoke Pharma investor relations website.
About Evoke Pharma, Inc.
Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The company developed, commercialized and markets GIMOTI, a nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults.
Diabetic gastroparesis is a GI disorder affecting millions of patients worldwide, in which the stomach takes too long to empty its contents resulting in serious GI symptoms as well as other systemic complications. The gastric delay caused by gastroparesis can compromise absorption of orally administered medications. Prior to FDA approval to commercially market GIMOTI, metoclopramide was only available in oral and injectable formulations and remains the only drug currently approved in the United States to treat gastroparesis.
Visit www.EvokePharma.com for more information.
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About Gimoti® (metoclopramide) nasal spray
GIMOTI is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Important Safety Information:
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2 년 전
Evoke Pharma Announces Approval of GIMOTI® to Florida State Medicaid Program
June 15, 2022 08:30 ET | Source: Evoke Pharma, Inc.
...
SOLANA BEACH, Calif., June 15, 2022 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI® (metoclopramide) nasal spray, today announced that the Florida Medicaid Pharmaceutical & Therapeutics Committee has approved adding GIMOTI, the Company’s novel treatment solution meant to treat symptoms associated with acute and recurrent diabetic gastroparesis, to the Florida Medicaid Preferred Drug List (PDL) effective immediately.
To prescribe Gimoti under the plan, healthcare providers need to attest to the patient being at least 18 years of age, having a diagnosis of diabetic gastroparesis, and being unable to use oral metoclopramide. These criteria are typical for Gimoti coverage under state Medicaid programs and consistent with Company expectations for utility in helping patients who suffer from this debilitating disease. Patients taking oral metoclopramide are often unable to achieve relief due to a delay in gastric emptying and erratic absorption of oral medication. We believe many patients can benefit from the novel nasal delivery of Gimoti to treat symptoms such as nausea, vomiting and abdominal pain. The Florida Medicaid formulary and related programs provide healthcare to approximately 5 million beneficiaries.
With this addition, we are building a strong foundation and momentum for positive access to GIMOTI within Medicaid lives in the US. “We view this addition to the Florida Medicaid PDL as a win for patient access to this important medicine for diabetic gastroparesis patients, who have very limited options to obtain symptomatic relief. In a world where many new products are excluded from formularies and patient access is denied, this decision is a significant commercial milestone for GIMOTI,” stated Matt D’Onofrio, MBA, Evoke Pharma’s Chief Business Officer. “Medicaid approvals across various jurisdictions are one of the primary components of our business plan to increase GIMOTI access. With this addition, we believe we are steadily executing the right strategies to ensure that healthcare providers around the country have the option to make GIMOTI the standard of care for diabetic gastroparesis.”
About Evoke Pharma, Inc.
Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The company developed, commercialized and markets GIMOTI, a nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults.
Diabetic gastroparesis is a GI disorder affecting millions of patients worldwide, in which the stomach takes too long to empty its contents resulting in serious GI symptoms as well as other systemic complications. The gastric delay caused by gastroparesis can compromise absorption of orally administered medications. Prior to FDA approval to commercially market GIMOTI, metoclopramide was only available in oral and injectable formulations and remains the only drug currently approved in the United States to treat gastroparesis. Visit www.EvokePharma.com for more information.
Follow GIMOTI on Facebook: https://www.facebook.com/GIMOTI-metoclopramide-nasal-spray-104672345100289
Follow Evoke Pharma on Facebook: https://www.facebook.com/Evoke-Pharma-Inc-131313647029724
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