Burlington, MA (GLOBE NEWSWIRE) - Flexion Therapeutics, Inc. (Nasdaq:FLXN) today reported top-line comes about because of a clinical trial to evaluate the impacts of its investigational lead tranquilize competitor, Zilretta (otherwise called FX006), on blood glucose levels in grown-ups with osteoarthritis (OA) of the knee who additionally have Type 2 diabetes. Comes about because of the trial exhibited Zilretta is connected with a factually huge (p<0.05, 2-sided) and clinically important diminishment in the ascent of blood glucose contrasted with that watched taking after quick discharge (IR) triamcinolone acetonide (TCA) infusion in patients who likewise have knee OA. Zilretta has beforehand exhibited clinically important change of torment, firmness and capacity in its Phase 3 vital trial in patients with knee OA.
The goal of the twofold visually impaired, randomized, parallel gathering, single-dosage study was to inspect if Zilretta had consequences for blood glucose levels that contrast from IR TCA. Examiners from seven study locales enlisted 33 patients, randomized 1:1 to get a solitary intra-articular infusion of 40 mg Zilretta or 40 mg IR TCA. Blood glucose levels were assessed for an aggregate of 3 weeks (one week before infusion and two weeks post infusion) utilizing a nonstop glucose checking gadget. Patients returned for follow up visits at Day 8, Day 15 and Week 6/Day 43. The essential endpoint looked at the adjustment in normal glucose values from the time of 72 hours before to the period 72 hours after infusion with Zilretta versus IR TCA.
"It is outstanding that prompt discharge corticosteroids can bring about significant rises in blood glucose among patients with diabetes taking after an intra-articular infusion, an impact that is likely fixing to top plasma fixations. Since pharmacokinetic considers have demonstrated that Zilretta is connected with much lower crest plasma fixations, we theorized that any ascent in glucose after a Zilretta infusion would be irrelevant. The information are predictable with this speculation and we are excitedly anticipating displaying the point by point concentrate on results at an up and coming logical gathering," said Michael Clayman, M.D., Flexion Therapeutics' President and Chief Executive Officer. "We trust these information show that Zilretta may restrict consequences for blood glucose which, if affirmed, could have future ramifications for the numerous knee OA patients in the U.S. who additionally have Type 2 diabetes. We anticipate incorporating these topline information in the Zilretta new medication application (NDA) which we plan to submit before the year's over."
"Interruption of glucose control taking after intra-articular glucocorticoid infusions is an issue for patients with diabetes mellitus," said Steven J. Russell, M.D., Ph.D., Assistant Professor of Medicine, Diabetes Research Center and Department of Medicine, Massachusetts General Hospital and Harvard Medical School. "Introductory investigation of the information from this precisely composed study recommends that Zilretta may not upset glucose control in individuals with sort 2 diabetes who require intra-articular steroid infusions for knee osteoarthritis. Empowering steroid treatment without glucose disturbance would be an essential clinical progress for patients with diabetes who are contender for glucocorticoid infusions."
Phone call Details
At 9:00 a.m. ET today, Flexion's administration will have a phone call to talk about the clinical results assessing Zilretta in Type 2 diabetes patients. The dial-in number for the telephone call is (855) 770-0022 for U.S. members and (908) 982-4677 for worldwide members, with Conference ID # 11746484. A live webcast of the phone call can likewise be gotten to through the "Financial specialists" tab on the Flexion Therapeutics site at www.flexiontherapeutics.com. A webcast replay will be accessible online after the call.
About Osteoarthritis of the Knee
While OA is as of now being analyzed at progressively more youthful ages, commonness ascends after age 45. In 2015, more than 14 million Americans were determined to have OA of the knee. OA speaks to a huge weight on the U.S. social insurance framework, influencing more than 27 million people and representing more than $185 billion in yearly uses. These expenses are required to ascend with an anticipated increment in OA pervasiveness, which is relied upon to influence 67 million Americans by 2030.
Every year, more than five million OA patients in the U.S. get quick discharge corticosteroid and hyaluronic corrosive intra-articular infusions for knee torment, however these infusions for the most part give restricted alleviation, and no option injectable treatment has been endorsed in over 10 years.
About Zilretta
Zilretta is being explored as the main intra-articular expanded discharge, non-opioid treatment for patients with direct to extreme knee OA torment. Zilretta utilizes restrictive microsphere innovation joining TCA – a normally regulated, short-acting corticosteroid – with a polymer (PLGA) expected to give diligent groupings of medication locally to both open up the greatness and drag out the term of agony help.
To date, more than 600 patients have been treated with Zilretta in clinical trials. No medication related genuine antagonistic occasions have been seen in these trials and unfriendly occasions have commonly been limited, mellow and practically identical to those saw with prompt discharge TCA and fake treatment. The information from these trials are predictable with Zilretta giving important and tough agony alleviation.
About Flexion Therapeutics
Flexion is a claim to fame pharmaceutical organization concentrated on the improvement and commercialization of novel, neighborhood treatments for the treatment of patients with musculoskeletal conditions, starting with OA. The organization's lead item applicant, Zilretta, is being explored for its capability to give enhanced pain relieving treatment to the a large number of U.S. patients who get intra-articular infusions for knee OA every year.
Forward-Looking Statements
Explanations in this official statement in regards to matters that are not chronicled actualities, including, but rather not constrained to, proclamations identifying with the eventual fate of Flexion; the potential advantages of Zilretta, incorporating into patients with knee OA and Type 2 diabetes; and anticipated development of OA and the potential market for Zilretta, are forward-looking articulations. These forward-looking explanations depend on administration's desires and suppositions as of the date of this public statement and are liable to various dangers and instabilities, which could bring about real results to contrast substantially from those communicated or inferred by such proclamations. These dangers and instabilities incorporate, without restriction, dangers connected with the way toward finding, creating, fabricating and getting administrative endorsement for medications that are protected and viable for use as human therapeutics; our dependence on outsiders to make and lead clinical trials of Zilretta, which could postpone or confine its future improvement or administrative endorsement; the way that we will require extra capital, including preceding commercializing Zilretta or some other item competitors, and might be not able get such extra capital in adequate sums or on terms worthy to us; the hazard that we will be unable to keep up and authorize our licensed innovation, including protected innovation identified with Zilretta; rivalry from option treatments; administrative advancements and wellbeing issues, incorporating challenges or deferrals in acquiring administrative endorsements to advertise Zilretta; the hazard that the FDA and remote administrative powers may not concur with our translation of the information from our clinical trials of Zilretta and may oblige us to direct extra clinical trials; Zilretta may not get administrative endorsement or be effectively popularized, including as a consequence of the FDA's or other administrative powers' choices in regards to naming and different matters that could influence its accessibility or business potential; dangers identified with key workers, markets, monetary conditions, medicinal services change, costs and repayment rates; and different dangers and vulnerabilities depicted in our filings with the Securities and Exchange Commission (SEC), including under the heading "Chance Factors" in our latest Annual Report on Form 10-K and consequent filings with the SEC. The forward-looking proclamations in this public statement talk just as of the date of this official statement, and we attempt no commitment to overhaul or reconsider any of the announcements. We alert financial specialists not to put impressive dependence on the forward-looking articulations contained in this public statement.
The goal of the twofold visually impaired, randomized, parallel gathering, single-dosage study was to inspect if Zilretta had consequences for blood glucose levels that contrast from IR TCA. Examiners from seven study locales enlisted 33 patients, randomized 1:1 to get a solitary intra-articular infusion of 40 mg Zilretta or 40 mg IR TCA. Blood glucose levels were assessed for an aggregate of 3 weeks (one week before infusion and two weeks post infusion) utilizing a nonstop glucose checking gadget. Patients returned for follow up visits at Day 8, Day 15 and Week 6/Day 43. The essential endpoint looked at the adjustment in normal glucose values from the time of 72 hours before to the period 72 hours after infusion with Zilretta versus IR TCA.
"It is outstanding that prompt discharge corticosteroids can bring about significant rises in blood glucose among patients with diabetes taking after an intra-articular infusion, an impact that is likely fixing to top plasma fixations. Since pharmacokinetic considers have demonstrated that Zilretta is connected with much lower crest plasma fixations, we theorized that any ascent in glucose after a Zilretta infusion would be irrelevant. The information are predictable with this speculation and we are excitedly anticipating displaying the point by point concentrate on results at an up and coming logical gathering," said Michael Clayman, M.D., Flexion Therapeutics' President and Chief Executive Officer. "We trust these information show that Zilretta may restrict consequences for blood glucose which, if affirmed, could have future ramifications for the numerous knee OA patients in the U.S. who additionally have Type 2 diabetes. We anticipate incorporating these topline information in the Zilretta new medication application (NDA) which we plan to submit before the year's over."
"Interruption of glucose control taking after intra-articular glucocorticoid infusions is an issue for patients with diabetes mellitus," said Steven J. Russell, M.D., Ph.D., Assistant Professor of Medicine, Diabetes Research Center and Department of Medicine, Massachusetts General Hospital and Harvard Medical School. "Introductory investigation of the information from this precisely composed study recommends that Zilretta may not upset glucose control in individuals with sort 2 diabetes who require intra-articular steroid infusions for knee osteoarthritis. Empowering steroid treatment without glucose disturbance would be an essential clinical progress for patients with diabetes who are contender for glucocorticoid infusions."
Phone call Details
At 9:00 a.m. ET today, Flexion's administration will have a phone call to talk about the clinical results assessing Zilretta in Type 2 diabetes patients. The dial-in number for the telephone call is (855) 770-0022 for U.S. members and (908) 982-4677 for worldwide members, with Conference ID # 11746484. A live webcast of the phone call can likewise be gotten to through the "Financial specialists" tab on the Flexion Therapeutics site at www.flexiontherapeutics.com. A webcast replay will be accessible online after the call.
About Osteoarthritis of the Knee
While OA is as of now being analyzed at progressively more youthful ages, commonness ascends after age 45. In 2015, more than 14 million Americans were determined to have OA of the knee. OA speaks to a huge weight on the U.S. social insurance framework, influencing more than 27 million people and representing more than $185 billion in yearly uses. These expenses are required to ascend with an anticipated increment in OA pervasiveness, which is relied upon to influence 67 million Americans by 2030.
Every year, more than five million OA patients in the U.S. get quick discharge corticosteroid and hyaluronic corrosive intra-articular infusions for knee torment, however these infusions for the most part give restricted alleviation, and no option injectable treatment has been endorsed in over 10 years.
About Zilretta
Zilretta is being explored as the main intra-articular expanded discharge, non-opioid treatment for patients with direct to extreme knee OA torment. Zilretta utilizes restrictive microsphere innovation joining TCA – a normally regulated, short-acting corticosteroid – with a polymer (PLGA) expected to give diligent groupings of medication locally to both open up the greatness and drag out the term of agony help.
To date, more than 600 patients have been treated with Zilretta in clinical trials. No medication related genuine antagonistic occasions have been seen in these trials and unfriendly occasions have commonly been limited, mellow and practically identical to those saw with prompt discharge TCA and fake treatment. The information from these trials are predictable with Zilretta giving important and tough agony alleviation.
About Flexion Therapeutics
Flexion is a claim to fame pharmaceutical organization concentrated on the improvement and commercialization of novel, neighborhood treatments for the treatment of patients with musculoskeletal conditions, starting with OA. The organization's lead item applicant, Zilretta, is being explored for its capability to give enhanced pain relieving treatment to the a large number of U.S. patients who get intra-articular infusions for knee OA every year.
Forward-Looking Statements
Explanations in this official statement in regards to matters that are not chronicled actualities, including, but rather not constrained to, proclamations identifying with the eventual fate of Flexion; the potential advantages of Zilretta, incorporating into patients with knee OA and Type 2 diabetes; and anticipated development of OA and the potential market for Zilretta, are forward-looking articulations. These forward-looking explanations depend on administration's desires and suppositions as of the date of this public statement and are liable to various dangers and instabilities, which could bring about real results to contrast substantially from those communicated or inferred by such proclamations. These dangers and instabilities incorporate, without restriction, dangers connected with the way toward finding, creating, fabricating and getting administrative endorsement for medications that are protected and viable for use as human therapeutics; our dependence on outsiders to make and lead clinical trials of Zilretta, which could postpone or confine its future improvement or administrative endorsement; the way that we will require extra capital, including preceding commercializing Zilretta or some other item competitors, and might be not able get such extra capital in adequate sums or on terms worthy to us; the hazard that we will be unable to keep up and authorize our licensed innovation, including protected innovation identified with Zilretta; rivalry from option treatments; administrative advancements and wellbeing issues, incorporating challenges or deferrals in acquiring administrative endorsements to advertise Zilretta; the hazard that the FDA and remote administrative powers may not concur with our translation of the information from our clinical trials of Zilretta and may oblige us to direct extra clinical trials; Zilretta may not get administrative endorsement or be effectively popularized, including as a consequence of the FDA's or other administrative powers' choices in regards to naming and different matters that could influence its accessibility or business potential; dangers identified with key workers, markets, monetary conditions, medicinal services change, costs and repayment rates; and different dangers and vulnerabilities depicted in our filings with the Securities and Exchange Commission (SEC), including under the heading "Chance Factors" in our latest Annual Report on Form 10-K and consequent filings with the SEC. The forward-looking proclamations in this public statement talk just as of the date of this official statement, and we attempt no commitment to overhaul or reconsider any of the announcements. We alert financial specialists not to put impressive dependence on the forward-looking articulations contained in this public statement.
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