JPWO2020058755A5 - - Google Patents
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- JPWO2020058755A5 JPWO2020058755A5 JP2021531495A JP2021531495A JPWO2020058755A5 JP WO2020058755 A5 JPWO2020058755 A5 JP WO2020058755A5 JP 2021531495 A JP2021531495 A JP 2021531495A JP 2021531495 A JP2021531495 A JP 2021531495A JP WO2020058755 A5 JPWO2020058755 A5 JP WO2020058755A5
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- collagenase composition
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- collagenase
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- 206010049752 Peau d'orange Diseases 0.000 claims description 16
- 230000036232 cellulite Effects 0.000 claims description 16
- 102000020504 Collagenase family Human genes 0.000 claims 46
- 108060005980 Collagenase family Proteins 0.000 claims 46
- 229960002424 collagenase Drugs 0.000 claims 45
- 239000000203 mixture Substances 0.000 claims 45
- 238000004166 bioassay Methods 0.000 claims 13
- 238000002347 injection Methods 0.000 claims 10
- 239000007924 injection Substances 0.000 claims 10
- 241000282326 Felis catus Species 0.000 claims 9
- 210000001624 Hip Anatomy 0.000 claims 5
- 210000001217 Buttocks Anatomy 0.000 claims 3
- 239000002131 composite material Substances 0.000 claims 2
- 238000002203 pretreatment Methods 0.000 claims 2
- GDBQQVLCIARPGH-ULQDDVLXSA-N (2S)-2-acetamido-N-[(2S)-1-[[(2S)-5-(diaminomethylideneamino)-1-oxopentan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]-4-methylpentanamide Chemical compound CC(C)C[C@H](NC(C)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@H](C=O)CCCN=C(N)N GDBQQVLCIARPGH-ULQDDVLXSA-N 0.000 claims 1
- 108090001092 Clostripain Proteins 0.000 claims 1
- 208000008313 Contusions Diseases 0.000 claims 1
- 102000013382 Gelatinases Human genes 0.000 claims 1
- 108010026132 Gelatinases Proteins 0.000 claims 1
- 210000003491 Skin Anatomy 0.000 claims 1
- 238000004458 analytical method Methods 0.000 claims 1
- 230000001186 cumulative Effects 0.000 claims 1
- 238000004128 high performance liquid chromatography Methods 0.000 claims 1
- 239000012535 impurity Substances 0.000 claims 1
- 108010052968 leupeptin Proteins 0.000 claims 1
- 229940068196 placebo Drugs 0.000 claims 1
- 239000000902 placebo Substances 0.000 claims 1
- 238000004007 reversed phase HPLC Methods 0.000 claims 1
- 238000007665 sagging Methods 0.000 claims 1
- 230000001225 therapeutic Effects 0.000 claims 1
- 241001340526 Chrysoclista linneella Species 0.000 description 2
- 230000000144 pharmacologic effect Effects 0.000 description 2
- 229960003556 Aminophylline Drugs 0.000 description 1
- FQPFAHBPWDRTLU-UHFFFAOYSA-N Aminophylline Chemical compound NCCN.O=C1N(C)C(=O)N(C)C2=C1NC=N2.O=C1N(C)C(=O)N(C)C2=C1NC=N2 FQPFAHBPWDRTLU-UHFFFAOYSA-N 0.000 description 1
- 229960000278 Theophylline Drugs 0.000 description 1
- 238000002679 ablation Methods 0.000 description 1
- 238000010317 ablation therapy Methods 0.000 description 1
- 239000006071 cream Substances 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 238000002647 laser therapy Methods 0.000 description 1
- 238000007443 liposuction Methods 0.000 description 1
- 238000000694 mesotherapy Methods 0.000 description 1
- 230000035479 physiological effects, processes and functions Effects 0.000 description 1
- 231100000486 side effect Toxicity 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 239000003860 topical agent Substances 0.000 description 1
- 230000004580 weight loss Effects 0.000 description 1
Description
セルライトを治療するために利用されてきた治療法があるが、承認された薬理学的治療法はない。複数の治療法があるにもかかわらず、現在の非薬理学的治療が有益であるという科学的根拠はほとんどない。実際、多くの根拠は逸話的、主観的、または患者の自己評価のみに基づいている。ＥＦＰの歴史的な治療法には、減量、外用剤、マッサージ、脂肪吸引、メソセラピー、高周波、切除、動力切除、レーザー治療などがある。これらの治療法の多くは望ましくない副作用がある（Avram MM, "Cellulite: a review of its physiology and treatment,"J Cosmet Laser Ther.2004;6(4):181-185; Collisら, "Cellulite treatment: a myth or reality: a prospective randomized, controlled trial of two therapies, endermologie and aminophylline cream, " Plast Reconstr Surg. 1999;104(4):1110-1114; Khan MH, Victor F, Rao B, Sadick NS. "Treatment of cellulite:Part I. Pathophysiology."J Am Acad Dermatol.2010;62(3):361-370; Hexsel DM, Mazzuco R. "Subcision: a treatment for cellulite. ".Int J Dermatol.2000;39(7):539-544; Boyce ら、, "Clinical evaluation of a device for the treatment of cellulite:Triactive." Am J Cosmet Surg. 2005;22:233-237; DiBernardo BE. "Treatment of cellulite using a 1440-nm pulsed laser with one year follow-up."Aesthet Surg J. 2011;31(3):328-341)。このように、多くの医師は美的状態の改善は簡単には得られないという見解を持っている。そのため、セルライトを持つ女性の審美的な結果を改善するための安全で効果的な非外科的治療法は、依然として満たされていない需要である。
この出願の発明に関連する先行技術文献情報としては、以下のものがある（国際出願日以降国際段階で引用された文献及び他国に国内移行した際に引用された文献を含む）。
（先行技術文献）
（特許文献）
（特許文献１） 国際公開第２０１３／０５９６１９号
（特許文献２） 国際公開第２００７／１００６７５号
（特許文献３） 国際公開第２０１８／１６０９０５号
Although there are treatments that have been utilized to treat cellulite, there are no approved pharmacological treatments. Despite multiple treatments, there is little scientific evidence that current non-pharmacological treatments are beneficial. In fact, much of the evidence is anecdotal, subjective, or based solely on patient self-assessment. Historical treatments for EFP include weight loss, topical agents, massage, liposuction, mesotherapy, radiofrequency, ablation, power ablation, and laser therapy. Many of these treatments have unwanted side effects (Avram MM, "Cellulite: a review of its physiology and treatment," J Cosmet Laser Ther. 2004;6(4):181-185; Collis et al., "Cellulite treatment : a myth or reality: a prospective randomized, controlled trial of two therapies, endermologie and aminophylline cream, "Plast Reconstr Surg. 1999;104(4):1110-1114; Khan MH, Victor F, Rao B, Sadick NS." Treatment of cellulite: Part I. Pathophysiology."J Am Acad Dermatol.2010;62(3):361-370; Hexsel DM, Mazzuco R. "Subcision: a treatment for cellulite.".Int J Dermatol.2000;39( 7):539-544; Boyce et al., "Clinical evaluation of a device for the treatment of cellulite: Triactive." Am J Cosmet Surg. 2005;22:233-237; DiBernardo BE. nm pulsed laser with one year follow-up."Aesthet Surg J. 2011;31(3):328-341). Thus, many physicians hold the view that improvement in aesthetic conditions cannot be easily obtained. Therefore, a safe and effective non-surgical treatment for improving the aesthetic results of women with cellulite remains an unmet need.
Prior art document information related to the invention of this application includes the following (including documents cited in the international phase after the international filing date and documents cited in the national phase of other countries).
(Prior art document)
(Patent document)
(Patent Document 1) International Publication No. 2013/059619
(Patent Document 2) International Publication No. 2007/100675
(Patent Document 3) International Publication No. 2018/160905
Claims (28)
以下の特徴：
ｉ．約０．０８～７．７０（ＳＲＣアッセイ）、または約０．３～３０．５（ＧＰＡアッセイ）のＶｍａｘ（分－１）；
ｉｉ．約４．１～４１０ナノモル（ＳＲＣアッセイ）、または約０．０３～３．１ｍＭ（ＧＰＡアッセイ）のＫＭ；
ｉｉｉ．約１．１～１０７（ＳＲＣアッセイ）、または約９３～９，１７９（ＧＰＡアッセイ）のＫｃａｔ（秒－１）；
ｉｖ．約３７６～３７，２２２（ＳＲＣアッセイ）、または約４～４２８（ＧＰＡアッセイ）の１／Ｋｃａｔ、マイクロ秒；
ｖ．約５，１４０～５０８，８１４（ＳＲＣアッセイ）、または約６０～５，９３４（ＧＰＡアッセイ）のＫｃａｔ／ＫＭ、ｍＭ－１秒－１；
ｖｉ．約６０ｋＤａ～約１３０ｋＤａ、または約７０ｋＤａ～約１３０ｋＤａ、または約８０ｋＤａ～約１２０ｋＤａ、または約９０ｋＤａ～約１２０ｋＤａ、または約１００ｋＤａ～約１１０ｋＤａの分子量；
ｖｉｉ．逆相ＨＰＬＣ（高圧液体クロマトグラフィー）で測定した面積比の純度が少なくとも８０％であること；
ｖｉｉｉ．約５，０００～約３０，０００ｆ－ＳＲＣ単位／ｍｇの力価；
ｉｘ．約１７５，０００～約５００，００ｆ－ＧＰＡ単位／ｍｇの力価；
ｘ．約５，０００～約２５，０００ＡＢＣ単位／ｍｇの力価；
ｘｉ．クロストリパイン、ゼラチナーゼおよびロイペプチンからなる群から選択される不純物が面積比で１％以下；
ｘｉｉ．１ｃｆｕ／ｍＬ以下のバイオバーデン；
のうち少なくとも２つを有し、
前記コラゲナーゼ組成物は、その治療有効量が前記患者の臀部の陥凹部に注射されるものであり、
前記セルライトの外観における改善が、ヘクセルセルライト重症度尺度（ヘクセルＣＳＳ）、ヘクセルくぼみ深さスコア、リッカート尺度、陥凹部分析、臨床医が報告したフォト数値セルライト重症度尺度（ＣＲ－ＰＣＳＳ）、患者が報告したフォト数値セルライト重症度尺度（ＰＲ－ＰＣＳＳ）、調査員グローバル美的改善尺度（Ｉ－ＧＡＩＳ）、被験者グローバル美的改善尺度（Ｓ－ＧＡＩＳ）、患者報告式セルライトインパクト尺度（ＰＲ－ＣＩＳ）、ＰＲ－ＣＩＳ省略形、被験者自己評価尺度（ＳＳＲＳ）、セルライト治療に対する被験者の満足度（ＳＳＣＴ）、セルライトの重症度の臨床医アセスメント（写真またはその他の画像）、Ｂｏｄｙ－Ｑ、セルライトの重症度、改善度、および／または患者の満足度を評価するために臨床医および／または患者が使用する検証済みのフォト数値またはその他の尺度、からなる群から選択される尺度または他の測定ツールによって確立されるものである、または、
あざが、治療後約３日から２０日の間に、色の濃さが有意に減少または消失する、
コラゲナーゼ組成物。 A collagenase composition for reducing the severity of cellulite in the buttocks of a human patient, said collagenase composition comprising:
Features below :
i. V max (min -1 ) of about 0.08-7.70 (SRC assay), or about 0.3-30.5 (GPA assay);
ii. a K M of about 4.1-410 nmol (SRC assay), or about 0.03-3.1 mM (GPA assay);
iii. K cat (sec −1 ) from about 1.1 to 107 (SRC assay), or from about 93 to 9,179 (GPA assay);
iv. 1/K cat of about 376-37,222 (SRC assay), or about 4-428 (GPA assay), microseconds;
v. K cat /K M of about 5,140-508,814 (SRC assay), or about 60-5,934 (GPA assay), mM −1 sec −1 ;
vi. a molecular weight of about 60 kDa to about 130 kDa, or about 70 kDa to about 130 kDa, or about 80 kDa to about 120 kDa, or about 90 kDa to about 120 kDa, or about 100 kDa to about 110 kDa;
vii. at least 80% area ratio purity as determined by reverse phase HPLC (high pressure liquid chromatography);
viii. a titer of about 5,000 to about 30,000 f-SRC units/mg;
ix. a potency of about 175,000 to about 500,00 f-GPA units/mg;
x. a potency of about 5,000 to about 25,000 ABC units/mg;
xi. An impurity selected from the group consisting of clostripain, gelatinase and leupeptin is 1% or less by area;
xii. bioburden of 1 cfu/mL or less;
having at least two of
wherein a therapeutically effective amount of the collagenase composition is injected into the gluteal recess of the patient;
The improvement in the appearance of cellulite was measured by the Hexel Cellulite Severity Scale (Hexel CSS), Hexel Cavity Depth Score, Likert Scale, Cavity Analysis, Clinician-Reported Photo-Numeric Cellulite Severity Scale (CR-PCSS), Patient-Reported Photo-Numeric Cellulite Severity Scale (PR-PCSS), Investigator Global Aesthetic Improvement Scale (I-GAIS), Subject Global Aesthetic Improvement Scale (S-GAIS), Patient Reported Cellulite Impact Scale (PR-CIS) , PR-CIS abbreviation, Subject Self-Rating Scale (SSRS), Subject's Satisfaction with Cellulite Treatment (SSCT), Clinician Assessment of Cellulite Severity (photograph or other image), Body-Q, Cellulite Severity , improvement, and/or validated photometric or other measures used by clinicians and/or patients to assess patient satisfaction. or
the bruise significantly decreases or disappears in color intensity between about 3 and 20 days after treatment;
Collagenase composition .
ａ．少なくとも５０％の患者が、２２、４３、または７１日目に、前記臀部の臨床医がライブで評価したＣＲ－ＰＣＳＳの重症度がベースラインから少なくとも１レベル改善していること；
ｂ．少なくとも５０％の患者が、２２、４３、または７１日目に、前記臀部のデジタル画像を見ながら被験者が評価したＰＲ－ＰＣＳＳの重症度がベースラインから少なくとも１レベル改善していること；
ｃ．患者の少なくとも５％が、２２、４３、または７１日目に、前記臀部の臨床医がライブで評価したＣＲ－ＰＣＳＳの重症度がベースラインから少なくとも２レベル改善していること；
ｄ．患者の少なくとも５％が、２２、４３、または７１日目に、前記臀部のデジタル画像を見ながら被験者が評価したＰＲ－ＰＣＳＳの重症度がベースラインから少なくとも２レベル改善していること；および
ｅ．少なくとも５％の患者が、陥凹部サイズの減少を経験すること；
から選択される結果をもたらすものである、コラゲナーゼ組成物。 2. The collagenase composition of claim 1, wherein the injection of said collagenase composition is targeted to a patient population who all have a CR-PCSS baseline assessment of moderate or severe, said injection comprising a group consisting of:
a. At least 50% of patients had at least 1 level of improvement from baseline in the live clinician-assessed severity of CR-PCSS on Days 22, 43, or 71;
b. At least 50% of patients had at least 1 level of improvement from baseline in subject-assessed severity of PR-PCSS while viewing the digital images of the buttocks on Days 22, 43, or 71;
c. At least 5% of patients had at least 2 levels of improvement from baseline in the live clinician-assessed CR-PCSS severity of the hip on Days 22, 43, or 71;
d. at least 5% of patients had at least 2 levels of improvement from baseline in subject-assessed severity of PR-PCSS while viewing said digital images of the buttocks on Days 22, 43, or 71; and e . At least 5% of patients experience a reduction in pit size;
A collagenase composition that provides a result selected from :
ａ．ＡＵＸ－Ｉ（ＳＲＣアッセイ）：
ｉ．Ｖｍａｘ ：約０．０８～７．７０分 －１
ｉｉ．ＫＭ：約４．１～４１０ナノモル
ｉｉｉ．Ｋｃａｔ ：約１．１～１０７秒 －１
ｉｖ．１／Ｋｃａｔ ：約３７６～３７，２２２マイクロ秒
ｖ．ｋｃａｔ／Ｋ Ｍ ：約５，１４０～５０８，８１４ｍＭ －１ 秒 －１
ｂ．ＡＵＸ－ＩＩ（ＧＰＡアッセイ）
ｉ．Ｖｍａｘ ：約０．３～３０．５分 －１
ｉｉ．Ｋ Ｍ ：約０．０３～３．１ｍＭ
ｉｉｉ．Ｋｃａｔ ：約９３～９，１７９秒 －１
ｉｖ．１／Ｋｃａｔ：約４～４２８マイクロ秒
ｖ．ｋｃａｔ／ＫＭ：約６０～５，９３４ｍＭ －１ 秒 －１
を有するＡＵＸ－ＩおよびＡＵＸ－ＩＩを有する、コラゲナーゼ組成物。 2. The collagenase composition of claim 1, characterized by:
a. AUX-I (SRC assay):
i. V max : about 0.08 to 7.70 min -1
ii. K M : about 4.1-410 nmol iii. K cat : about 1.1 to 107 sec -1
iv. 1/K cat : about 376-37,222 microseconds
v. k cat /K M : about 5,140 to 508,814 mM −1 sec −1
b. AUX-II (GPA assay)
i. V max : about 0.3 to 30.5 min -1
ii. KM : about 0.03-3.1 mM
iii. K cat : about 93 to 9,179 sec -1
iv. 1/K cat : about 4 to 428 microseconds
v. k cat /K M : about 60 to 5,934 mM −1 sec −1
A collagenase composition having AUX-I and AUX-II having
ａ．２２、４３、７１、９０、１８０、または３６５日目に、前記臀部の臨床医がライブで評価したＣＲ－ＰＣＳＳの重症度がベースライン（治療前の「１日目」）から少なくとも２レベル改善していること；
ｂ．２２、４３、７１、９０、１８０、または３６５日目に、前記臀部のデジタル画像を見ながら患者が評価したＰＲ－ＰＣＳＳの重症度が、ベースライン（１日目）から少なくとも２レベル改善していること；
ｃ．前記ＣＲ－ＰＣＳＳにおいてベースラインから少なくとも２レベルの重症度の改善があり、および、前記ＰＲ－ＰＣＳＳにおいてベースラインから少なくとも２レベルの重症度の改善がある患者と定義される、２２、４３、７１、９０、１８０、または３６５日目に、２レベルの複合応答によって示された改善；
ｄ．２２、４３、７１、９０、１８０、または３６５日目に、前記臀部の臨床医がライブで評価したＣＲ－ＰＣＳＳの重症度が、ベースライン（１日目）から少なくとも１レベル改善していること；
ｅ．２２、４３、７１、９０、１８０、または３６５日目に、前記臀部のデジタル画像を見ながら患者が評価したＰＲ－ＰＣＳＳの重症度が、ベースライン（１日目）から少なくとも１レベル改善していること；
ｆ．前記ＣＲ－ＰＣＳＳにおいてベースラインから少なくとも１レベルの重症度の改善があり、および、前記ＰＲ－ＰＣＳＳにおいてベースラインから少なくとも１レベルの重症度の改善がある患者と定義される、２２、４３、７１、９０、１８０、または３６５日目に、１レベルの複合応答によって示される改善；および
ｇ．ベースライン時に全員のＣＲ－ＰＣＳＳまたはＰＲ－ＰＣＳＳ評価が中等度または重度であった患者集団において、少なくとも１つの治療領域における改善がプラセボと比較して統計的に有意であり、その改善が上記ａ．からｆ．の１つ以上であること；
のうち少なくとも１つの結果をもたらすものである、コラゲナーゼ組成物。 The collagenase composition of claim 1, wherein the injection of said collagenase composition has the following efficacy endpoints as measured by CR-PCSS and/or PR-PCSS:
a. Improvement in the severity of CR-PCSS assessed live by the hip clinician by at least 2 levels from baseline (pre-treatment "Day 1") on Days 22, 43, 71, 90, 180, or 365 Doing things;
b. On Days 22, 43, 71, 90, 180, or 365, the severity of PR-PCSS, as assessed by the patient while viewing the digital image of the hip, improved by at least 2 levels from baseline (Day 1). to be;
c. defined as patients with at least 2 levels of improvement in severity from baseline in the CR-PCSS and at least 2 levels of improvement in severity from baseline in the PR-PCSS,22,43,71 improvement indicated by two levels of composite response on days , 90, 180, or 365;
d. At least 1 level of improvement from baseline (Day 1) in the severity of CR-PCSS as assessed live by the hip clinician on Days 22, 43, 71, 90, 180, or 365 ;
e. On Days 22, 43, 71, 90, 180, or 365, the severity of PR-PCSS, as assessed by the patient while viewing the digital image of the hip, improved by at least 1 level from baseline (Day 1). to be;
f. defined as patients with at least 1 level of improvement in severity from baseline in the CR-PCSS and at least 1 level of improvement in severity from baseline in the PR-PCSS,22,43,71 , 90, 180, or 365 days, an improvement indicated by a 1-level composite response; and g. Statistically significant improvement in at least one therapeutic area compared to placebo in the patient population with all CR-PCSS or PR-PCSS ratings of moderate or severe at baseline, and the improvement is above a . to f. be one or more of
A collagenase composition that provides at least one result of
ａ．深さが少なくとも５％減少する；
ｂ．幅が少なくとも５％減少する；
ｃ．長さが少なくとも５％減少する；
ｄ．全体の体積が少なくとも５％減少する；
ｅ．表面積が少なくとも５％減少する；
のうち少なくとも１つをもたらすものである、コラゲナーゼ組成物。 2. The collagenase composition of claim 1, wherein the injection of said collagenase composition has the following efficacy endpoints as measured by recession assay:
a. depth is reduced by at least 5%;
b. decrease in width by at least 5%;
c. decrease in length by at least 5%;
d. overall volume is reduced by at least 5%;
e. surface area is reduced by at least 5%;
A collagenase composition that provides at least one of
Applications Claiming Priority (13)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
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