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November 01, 2016 07:00 ET | Source: Flexion Therapeutics
- Results Demonstrate a Markedly Lower Rise in Blood Glucose in Patients Receiving a Zilretta Injection Compared to Patients Receiving an Immediate-Release Triamcinolone Acetonide Injection -
- Difference was Both Statistically Significant and Clinically Relevant -
- Conference Call Scheduled for Today, November 1, 2016, at 9:00 a.m. ET -
BURLINGTON, Mass., Nov. 01, 2016 (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 sedate hopeful, Zilretta (otherwise called FX006), on blood glucose levels in grown-ups with osteoarthritis (OA) of the knee who likewise have Type 2 diabetes. Comes about because of the trial exhibited Zilretta is connected with a factually noteworthy (p<0.05, 2-sided) and clinically applicable decrease in the ascent of blood glucose contrasted with that watched taking after quick discharge (IR) triamcinolone acetonide (TCA) infusion in patients who additionally have knee OA. Zilretta has beforehand exhibited clinically important change of torment, firmness and capacity in its Phase 3 essential trial in patients with knee OA.
The target of the twofold visually impaired, randomized, parallel gathering, single-measurement study was to analyze if Zilretta had impacts on blood glucose levels that vary from IR TCA. Specialists 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 a sum of 3 weeks (one week before infusion and two weeks post infusion) utilizing a constant glucose checking gadget. Patients returned for follow up visits at Day 8, Day 15 and Week 6/Day 43. The essential endpoint thought about 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 quick 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 crest plasma focuses. Since pharmacokinetic examines have demonstrated that Zilretta is connected with much lower top plasma focuses, we speculated that any ascent in glucose after a Zilretta infusion would be irrelevant. The information are steady with this theory and we are eagerly anticipating exhibiting the point by point consider comes about at an up and coming logical gathering," said Michael Clayman, M.D., Flexion Therapeutics' President and Chief Executive Officer. "We trust these information exhibit that Zilretta may restrain consequences for blood glucose which, if affirmed, could have future ramifications for the numerous knee OA patients in the U.S. who likewise 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 examination of the information from this deliberately planned study proposes that Zilretta may not disturb glucose control in individuals with sort 2 diabetes who require intra-articular steroid infusions for knee osteoarthritis. Empowering steroid treatment without glucose interruption would be a critical clinical progress for patients with diabetes who are possibility for glucocorticoid infusions."
Phone call Details
At 9:00 a.m. ET today, Flexion's administration will have a phone call to examine the clinical results assessing Zilretta in Type 2 diabetes patients. The dial-in number for the phone call is (855) 770-0022 for U.S. members and (908) 982-4677 for universal 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 at present 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 tremendous weight on the U.S. human services 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 predominance, 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 constrained alleviation, and no option injectable treatment has been endorsed in over 10 years.
About Zilretta
Zilretta is being examined as the principal intra-articular broadened discharge, non-opioid treatment for patients with direct to extreme knee OA torment. Zilretta utilizes restrictive microsphere innovation joining TCA – an ordinarily managed, short-acting corticosteroid – with a polymer (PLGA) proposed to give steady groupings of medication locally to both open up the extent and draw out the term of torment alleviation.
To date, more than 600 patients have been treated with Zilretta in clinical trials. No medication related genuine unfavorable occasions have been seen in these trials and unfriendly occasions have normally been limited, gentle and equivalent to those saw with quick discharge TCA and fake treatment. The information from these trials are steady with Zilretta giving significant and sturdy torment alleviation.
About Flexion Therapeutics
Flexion is a claim to fame pharmaceutical organization concentrated on the improvement and commercialization of novel, nearby treatments for the treatment of patients with musculoskeletal conditions, starting with OA. The organization's lead item competitor, Zilretta, is being explored for its capability to give enhanced pain relieving treatment to the a great many U.S. patients who get intra-articular infusions for knee OA every year.
Forward-Looking Statements
Articulations in this official statement in regards to matters that are not authentic actualities, including, but rather not restricted to, explanations 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 proclamations. These forward-looking proclamations depend on administration's desires and suppositions as of the date of this public statement and are liable to various dangers and vulnerabilities, which could bring about real results to vary tangibly from those communicated or suggested by such explanations. These dangers and vulnerabilities incorporate, without constraint, dangers connected with the way toward finding, creating, fabricating and acquiring administrative endorsement for medications that are sheltered and compelling for use as human therapeutics; our dependence on outsiders to make and lead clinical trials of Zilretta, which could postpone or confine its future advancement or administrative endorsement; the way that we will require extra capital, including before commercializing Zilretta or whatever 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 most likely be unable to keep up and authorize our protected innovation, including licensed innovation identified with Zilretta; rivalry from option treatments; administrative improvements and wellbeing issues, incorporating challenges or deferrals in getting administrative endorsements to advertise Zilretta; the hazard that the FDA and remote administrative powers may not concur with our understanding 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 an aftereffect 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 instabilities 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 ensuing filings with the SEC. The forward-looking explanations in this public statement talk just as of the date of this official statement, and we attempt no commitment to redesign or reconsider any of the announcements. We alert financial specialists not to put impressive dependence on the forward-looking proclamations contained in this public statement.
Financial specialist Contact
David Carey
Lazar Partners LTD
T: 212-867-1768
dcarey@lazarpartners.com
Media Contact
Danielle Lewis
Lazar Partners LTD
T: 212-843-0211
dlewis@lazarpartners.com
Corporate Contact
Fred Driscoll
CFO
Flexion Therapeutics, Inc.
T: 781-305-7763
fdriscoll@flexiontherapeutics.com
November 01, 2016 07:00 ET | Source: Flexion Therapeutics
- Results Demonstrate a Markedly Lower Rise in Blood Glucose in Patients Receiving a Zilretta Injection Compared to Patients Receiving an Immediate-Release Triamcinolone Acetonide Injection -
- Difference was Both Statistically Significant and Clinically Relevant -
- Conference Call Scheduled for Today, November 1, 2016, at 9:00 a.m. ET -
BURLINGTON, Mass., Nov. 01, 2016 (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 sedate hopeful, Zilretta (otherwise called FX006), on blood glucose levels in grown-ups with osteoarthritis (OA) of the knee who likewise have Type 2 diabetes. Comes about because of the trial exhibited Zilretta is connected with a factually noteworthy (p<0.05, 2-sided) and clinically applicable decrease in the ascent of blood glucose contrasted with that watched taking after quick discharge (IR) triamcinolone acetonide (TCA) infusion in patients who additionally have knee OA. Zilretta has beforehand exhibited clinically important change of torment, firmness and capacity in its Phase 3 essential trial in patients with knee OA.
The target of the twofold visually impaired, randomized, parallel gathering, single-measurement study was to analyze if Zilretta had impacts on blood glucose levels that vary from IR TCA. Specialists 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 a sum of 3 weeks (one week before infusion and two weeks post infusion) utilizing a constant glucose checking gadget. Patients returned for follow up visits at Day 8, Day 15 and Week 6/Day 43. The essential endpoint thought about 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 quick 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 crest plasma focuses. Since pharmacokinetic examines have demonstrated that Zilretta is connected with much lower top plasma focuses, we speculated that any ascent in glucose after a Zilretta infusion would be irrelevant. The information are steady with this theory and we are eagerly anticipating exhibiting the point by point consider comes about at an up and coming logical gathering," said Michael Clayman, M.D., Flexion Therapeutics' President and Chief Executive Officer. "We trust these information exhibit that Zilretta may restrain consequences for blood glucose which, if affirmed, could have future ramifications for the numerous knee OA patients in the U.S. who likewise 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 examination of the information from this deliberately planned study proposes that Zilretta may not disturb glucose control in individuals with sort 2 diabetes who require intra-articular steroid infusions for knee osteoarthritis. Empowering steroid treatment without glucose interruption would be a critical clinical progress for patients with diabetes who are possibility for glucocorticoid infusions."
Phone call Details
At 9:00 a.m. ET today, Flexion's administration will have a phone call to examine the clinical results assessing Zilretta in Type 2 diabetes patients. The dial-in number for the phone call is (855) 770-0022 for U.S. members and (908) 982-4677 for universal 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 at present 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 tremendous weight on the U.S. human services 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 predominance, 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 constrained alleviation, and no option injectable treatment has been endorsed in over 10 years.
About Zilretta
Zilretta is being examined as the principal intra-articular broadened discharge, non-opioid treatment for patients with direct to extreme knee OA torment. Zilretta utilizes restrictive microsphere innovation joining TCA – an ordinarily managed, short-acting corticosteroid – with a polymer (PLGA) proposed to give steady groupings of medication locally to both open up the extent and draw out the term of torment alleviation.
To date, more than 600 patients have been treated with Zilretta in clinical trials. No medication related genuine unfavorable occasions have been seen in these trials and unfriendly occasions have normally been limited, gentle and equivalent to those saw with quick discharge TCA and fake treatment. The information from these trials are steady with Zilretta giving significant and sturdy torment alleviation.
About Flexion Therapeutics
Flexion is a claim to fame pharmaceutical organization concentrated on the improvement and commercialization of novel, nearby treatments for the treatment of patients with musculoskeletal conditions, starting with OA. The organization's lead item competitor, Zilretta, is being explored for its capability to give enhanced pain relieving treatment to the a great many U.S. patients who get intra-articular infusions for knee OA every year.
Forward-Looking Statements
Articulations in this official statement in regards to matters that are not authentic actualities, including, but rather not restricted to, explanations 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 proclamations. These forward-looking proclamations depend on administration's desires and suppositions as of the date of this public statement and are liable to various dangers and vulnerabilities, which could bring about real results to vary tangibly from those communicated or suggested by such explanations. These dangers and vulnerabilities incorporate, without constraint, dangers connected with the way toward finding, creating, fabricating and acquiring administrative endorsement for medications that are sheltered and compelling for use as human therapeutics; our dependence on outsiders to make and lead clinical trials of Zilretta, which could postpone or confine its future advancement or administrative endorsement; the way that we will require extra capital, including before commercializing Zilretta or whatever 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 most likely be unable to keep up and authorize our protected innovation, including licensed innovation identified with Zilretta; rivalry from option treatments; administrative improvements and wellbeing issues, incorporating challenges or deferrals in getting administrative endorsements to advertise Zilretta; the hazard that the FDA and remote administrative powers may not concur with our understanding 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 an aftereffect 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 instabilities 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 ensuing filings with the SEC. The forward-looking explanations in this public statement talk just as of the date of this official statement, and we attempt no commitment to redesign or reconsider any of the announcements. We alert financial specialists not to put impressive dependence on the forward-looking proclamations contained in this public statement.
Financial specialist Contact
David Carey
Lazar Partners LTD
T: 212-867-1768
dcarey@lazarpartners.com
Media Contact
Danielle Lewis
Lazar Partners LTD
T: 212-843-0211
dlewis@lazarpartners.com
Corporate Contact
Fred Driscoll
CFO
Flexion Therapeutics, Inc.
T: 781-305-7763
fdriscoll@flexiontherapeutics.com
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