WO2024148128A1 - Formes pharmaceutique d'hormone de stimulation folliculaire et procédés - Google Patents

Formes pharmaceutique d'hormone de stimulation folliculaire et procédés Download PDF

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Publication number
WO2024148128A1
WO2024148128A1 PCT/US2024/010246 US2024010246W WO2024148128A1 WO 2024148128 A1 WO2024148128 A1 WO 2024148128A1 US 2024010246 W US2024010246 W US 2024010246W WO 2024148128 A1 WO2024148128 A1 WO 2024148128A1
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WIPO (PCT)
Prior art keywords
fsh
composition
subject
structured
ingestible device
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Application number
PCT/US2024/010246
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English (en)
Inventor
Mir Imran
Mir Hashim
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Rani Therapeutics, Llc
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Publication of WO2024148128A1 publication Critical patent/WO2024148128A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/24—Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A61M31/002—Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis

Definitions

  • the present disclosure relates generally to compositions, dosage forms, devices, and methods for delivery of follicle stimulating hormone (FSH) by ingestion. More specifically, the present disclosure relates to ingestible dosage forms (e.g., ingestible devices) that contain a composition comprising FSH that are structured and formulated to deliver therapeutically effective amounts of FSH into a gastrointestinal (GI) lumen wall (e.g., stomach wall, intestinal wall, colon, etc.) of the subject or surrounding tissue thereof (e.g., peritoneum or peritoneal cavity) to achieve desired pharmacokinetic and therapeutic results.
  • GI gastrointestinal
  • compositions, devices, and methods may be useful, for example, for treating infertility (e.g., stimulating follicle development or stimulating ovulation induction in a female patient or treating hypogonadotropic hypogonadism or idiopathic infertility in a male patient (e.g., for stimulation of spermatogenesis)) and other conditions in which treatment with FSH may be indicated.
  • infertility e.g., stimulating follicle development or stimulating ovulation induction in a female patient or treating hypogonadotropic hypogonadism or idiopathic infertility in a male patient (e.g., for stimulation of spermatogenesis)
  • FSH idiopathic infertility
  • FSH pharmaceutical products that are administered by subcutaneous or intramuscular injection.
  • FSH products contain FSH extracted from the urine of post-menopausal women (e.g., REPRONEX®, MENOPUR®, and BRAVELLE®).
  • Other approved FSH products contain recombinant FSH, e.g., recombinant human FSH expressed in mammalian cells, such as Chinese Hamster Ovary (CHO) cells (e.g., GONAL-F® and FOLLISTIM®) or expressed in a human cell line such as the Per.C6 cell line (REKOVELLE®).
  • mammalian cells such as Chinese Hamster Ovary (CHO) cells (e.g., GONAL-F® and FOLLISTIM®) or expressed in a human cell line such as the Per.C6 cell line (REKOVELLE®).
  • Urinary-derived and CHO-cell derived FSH products are dosed in terms of international units, with typical doses ranging from 50 IU to 450 IU depending on the patient and condition being treated.
  • GONAL-F® follitropin alfa
  • GONAL-F® follitropin alfa
  • REKOVELLE® follitropin delta
  • REKOVELLE® follitropin delta
  • ART assisted reproductive technologies
  • IVF in vitro fertilization
  • ICSI intracytoplasmic sperm injection
  • REKOVELLE® follitropin delta
  • AMH serum anti -Mullerian hormone
  • Reported clinical trial data suggest that a daily dose of 10.0 pg REKOVELLE® (follitropin delta) provides, for the majority of patients, an ovarian response close to that obtained with 150 lU/day GONAL-F® (follitropin delta).
  • ingestible devices containing a payload formed from, or containing, a composition comprising FSH, wherein the device is structured to deliver the composition into a gastrointestinal (GI) lumen wall of the subject or surrounding tissue thereof.
  • the FSH may be urinary-derived human FSH.
  • the FSH may be recombinant human FSH.
  • the device may contain a dose of FSH of from about 75 IU to about 450 IU, optionally wherein the FSH is follitropin alfa.
  • the device may contain a dose of FSH selected from 75 IU, 100 IU, 125 IU, 150 IU, 175 IU, 200 IU, 225 IU, 250 IU, 275 IU, 300 IU, 325 IU, 350 IU, 375 IU, 400 IU, 425 IU, and 450 IU, optionally wherein the FSH is follitropin alfa.
  • the device may contain a dose of FSH of about 12 pg, optionally wherein the FSH is follitropin delta.
  • the composition may comprise the FSH, a lubricant, a bulking agent, an antioxidant, and, optionally, a buffering agent.
  • the composition may comprise the FSH, a phosphate salt, PEG-3350, D-mannitol, and L-methionine.
  • the composition may comprise about 1 % w/w of FSH, about 2 % w/w of phosphate salts, about 5 % PEG-3350, about 52 % D mannitol, and about 40% w/w L-methionine.
  • the composition may comprise about 3.5 % w/w of FSH, about 6.5 % w/w of phosphate salts, about 5 % PEG- 3350, about 45 % D mannitol, and about 40% w/w L-methionine.
  • the payload may be in the form of a solid tissue penetrating member structured to be inserted into a GI lumen wall of the subject or surrounding tissue thereof.
  • the composition may be fdled in a hollow, biodegradable microneedle constituting the solid tissue penetrating member.
  • the composition may be a shaped mass constituting the solid tissue penetrating member.
  • the device may comprise one or multiple payloads of the FSH.
  • the device may be structured to deliver one or more payloads into the GI lumen wall or surrounding tissue thereof at different times.
  • the ingestible device may be comprised within a swallowable capsule.
  • the device may be structured to deliver the composition into a stomach wall of the subject.
  • the device may be structured to deliver the composition into an intestinal wall of the subject.
  • the device may be structured to deliver the composition into a wall of the small intestine.
  • the device may be structured to deliver the composition into the peritoneum, or peritoneal cavity of the subject.
  • the bioavailability of FSH administered by the device may be substantially the same as a bioavailability of subcutaneously administered FSH.
  • a device as described herein in methods of administering FSH to a subject in need thereof.
  • the uses and methods include administering to the subject by ingestion an ingestible device as described herein containing a payload formed from, or containing, a composition comprising FSH in accordance with any embodiments described herein, wherein the device is structured to deliver the composition into a gastrointestinal (GI) lumen wall of the subject surrounding tissue thereof (e.g., peritoneum or peritoneal cavity).
  • GI gastrointestinal
  • the uses and methods may be for treatment of infertility.
  • the uses and methods may be for stimulating follicle development in a female patient.
  • the uses and methods may be for stimulating ovulation induction in a female patient.
  • the uses and methods may be for one or more of treating hypogonadotropic hypogonadism in a male patient, treating idiopathic infertility in a male patient, and stimulation of spermatogenesis in a male patient.
  • the uses and methods may comprise once daily administration of the ingestible device.
  • the uses and methods may comprise twice daily administration of the ingestible device.
  • GI gastrointestinal
  • FIG. 1A shows an example of an embodiment of an expandable component of a selfsizing device as disclosed herein prior to being folded and/or rolled, and an example of an embodiment of a capsule as disclosed herein.
  • Figure IB shows the expandable component of FIG. 1A in an embodiment of a folded and/or rolled arrangement prior to disposing the expandable component in the capsule.
  • FIG. 4A shows an example of an embodiment of a self-sizing device as disclosed herein including an expandable component with one non-compliant section and no hinge.
  • FIG. 4B shows an example of an embodiment of a self-sizing device including an expandable component with two non-compliant sections and one hinge.
  • FIG. 5 shows an embodiment of a capsule as disclosed herein encompassing an ingestible device.
  • Inset A shows a fully assembled enteric-coated capsule.
  • Schematic B shows various parts and components of the capsule.
  • FIG. 9 shows results of a computer-based pharmacokinetic model simulation of FSH dosing, plotting simulated plasma concentration vs. time curves from a pharmacokinetic model simulation of FSH dosing at 100 IU twice daily with one missed dose on Day 3 vs. 100 IU twice daily without missed dose vs. 150 IU once daily vs. 225 IU once daily.
  • a GI lumen wall e.g., stomach wall, intestinal wall, colon, etc.
  • tissue thereof e.g., a peritoneum or peritoneal cavity
  • the payload may be in the form of a solid tissue penetrating member structured to penetrate a GI lumen wall of the subject and/or be inserted into a peritoneum or peritoneal cavity of the subject after ingestion of the device.
  • the ingestible device may be disposed within a capsule, such as a swallowable capsule.
  • the terms “substantially” and “about” when used with a numerical value mean the numerical value stated as well as up to and including plus or minus 10% of the numerical value. For example, “about 10” should be understood as both “10” and “in a range between and including 9 and 11”.
  • a phrase in the form “A/B” or in the form “A and/or B” means (A), (B), or (A and
  • the phrase “therapeutically effective amount” with reference to FSH means a dose that provides the specific pharmacological effect for which the drug is administered in a subject in need of such treatment. It is emphasized that a therapeutically effective amount of FSH will not always be effective in treating the condition for which it is administered in every individual subject, even though such dose is deemed to be a therapeutically effective amount by those of skill in the art. Those skilled in the art can adjust what is deemed to be a therapeutically effective amount in accordance with standard practices as needed to treat a specific subject. A therapeutically effective amount may vary based on, for example, the age and weight of the subject, and/or the subject’s overall health, the condition being treated, and/or the severity of the condition of the subject being treated.
  • a “therapeutic level” of circulating FSH in a human subject means a plasma level associated with the specific pharmacological effect for which the drug is administered in a subject in need of such treatment.
  • a “therapeutic level” of circulating FSH in a human female patient being treated for infertility may be a plasma level sufficient to stimulate follicle development or to stimulate ovulation induction, such as a plasma level of about 10-12 IU/L (10-12 mIU/mL).
  • lumen refers herein to the inside space of a tubular structure. Examples of lumens in a body include arteries, veins, and tubular cavities within organs.
  • gastrointestinal lumen or “GI lumen” refers generally to any lumen of the GI tract (e.g., a lumen of the esophagus, stomach, small intestine, large intestine, or colon); the term “GI lumen wall” refers to a lumen wall of a GI lumen.
  • lumen wall refers to a wall of a lumen, where the wall includes all layers from an inner perimeter to an outer perimeter of the lumen, such as, with respect to lumens in a body, the mucosa, submucosa, muscularis, serosa, and an outer wall of the lumen, with the constituent blood vessels and tissues.
  • gastrointestinal tract refers herein to the intake/expulsion system of a body including, for example, the mouth, pharynx, esophagus, stomach, pylorus, small intestine, cecum, large intestine, colon, rectum, anus, and valves or sphincters therebetween.
  • degrading or a grammatical variation thereof (e.g., “degrading”, “degraded”, “degradable”, and “degradation”) refers herein to weakening, partially degrading, or fully degrading, such as by dissolution, chemical degradation (including biodegradation), decomposition, chemical modification, mechanical degradation, or disintegration, which encompasses also, without limitation, dissolving, crumbling, deforming, shriveling, or shrinking.
  • non-degradable refers to an expectation that degradation will be minimal, or within a certain acceptable design percentage, for at least an expected duration in an expected environment.
  • FSH composition follicle stimulating hormone composition
  • composition of FSH composition of FSH
  • the FSH composition can include FSH either as the sole active agent or along with one or more additional active agents.
  • ingestible dosage forms useful for delivering FSH to a subject in need thereof.
  • the devices contain a payload formed from, or containing, a composition comprising FSH, and are structured to deliver the composition into a GI lumen wall of the subject or surrounding tissue thereof, e.g., a peritoneum or peritoneal cavity of the subject, after ingestion.
  • the FSH provided in the devices may be any form of human FSH, including one or more of FSH isolated from human urine (human urinary-derived FSH) (e.g., REPRONEX®, MENOPUR®, and BRAVELLE®), and recombinant FSH, including recombinant human FSH expressed in mammalian cells, such as CHO cells (e.g., GONAL-F® (follitropin alfa) and FOLLISTIM® (follitropin beta)) or expressed in a human cell line such as the Per.C6 cell line (REKOVELLE® (follitropin delta).
  • any devices disclosed or referenced herein optionally may be disposed within a capsule, such as a swallowable capsule.
  • the materials used to form the components of the devices are classified as food grade, food additive, active or inactive food ingredient or GRAS (Generally Recognized As Safe by the FDA).
  • the devices may be biodegradable.
  • the device may contain a mechanism to effectuate delivery of the payload into a location of the GI tract, such as the intestinal wall or into and through an intestinal wall into, e.g., a peritoneum or peritoneal cavity of the subject.
  • the mechanism includes an actuator that is triggered when the device is at a target delivery site, such as within the intestine.
  • the mechanism may effectuate delivery of the pay load at another location in the GI tract, such as the stomach, large intestine, or colon.
  • a portion of the valve When exposed to fluid such as intestinal fluid (e.g., after the capsule degrades), a portion of the valve degrades and allows the two reactants to mix, which results in formation of a gas (e.g., carbon dioxide or other innocuous gas) that expands the balloon.
  • a gas e.g., carbon dioxide or other innocuous gas
  • Inflation of the balloon aligns the Microsyringe substantially perpendicular to the long axis of the intestine and builds pressure in the balloon sufficient to provide the force needed to eject the Microneedle from the Microsyringe and inject the Microneedle into the intestinal wall or surrounding tissue thereof.
  • the balloon deflates and the balloon and other components are excreted out through the GI tract with normal bowel movements.
  • the shell is approximately needle-shaped. Degradation of the payload may occur within 1, 2, 3, 4, or 5 minutes of injection into the intestinal wall, or may take longer. Properties of the payload (e.g., structure and/or material) may be selected to delay release of the FSH from the payload.
  • the device may include a detectable marker, such as a radiolabel, to assist in tracking the device as it proceeds through the subject’s GI tract.
  • a detectable marker such as a radiolabel
  • markers include, but are not limited to, barium sulfate (whose dispersion indicates fluid ingress inside the device and imminent delivery of the payload) and bismuth, which optionally may be included on or in a component contained in the device to radiographically track the component’s transit along the GI tract as well as to confirm its excretion.
  • a balloon is selfsizing.
  • the balloon is referred to herein as an “expandable component”. Such embodiments are described in more detail in the following paragraphs.
  • the expandable component includes multiple sections. In the expanded configuration of the expandable component, at least one of the sections is non-compliant and at least one of the sections is compliant. Compliant refers to a state in which the section may be readily deformed, and non-compliant refers to a state in which the section resists deformation.
  • each section will expand to a fully-extended state and the expandable component will reach its maximum dimensions, which may depend, for example, on materials used to form the expandable component and/or a capacity of an expansion module that is implemented (e.g., for expansion by inflation, maximum dimensions may be influenced by a limitation on an inflation force available from the expansion module, or by a stretch factor of a material or materials of the expandable component).
  • the expansion module is part of a mechanism to effectuate delivery of the payload into the intestinal wall.
  • This bending is due to the smaller dimension(s) of the hinge as compared to the corresponding dimension(s) of the non-compliant section(s), which in the expanded configuration of the expandable component leads to lower rigidity of the hinge as compared to rigidity of the non-compliant section(s).
  • FIG. 2C illustrates that, subsequent to (or concurrent with) capsule shell 1010 degrading, expandable component 1000 begins to unfurl from its folded and/or rolled arrangement.
  • the composition comprises about 3% w/w FSH, about 7% w/w phosphate salts, about 45% D-mannitol, about 5% PEG-3550, and about 40% L-methionine.
  • such a composition is used to provide a dose of 450 IU FSH (follitropin alfa).
  • FSH follitropin alfa
  • compositions can be formulated to provided other doses as described herein in about the same volume/mass, such as by adjusting the FSH concentration (higher or lower), and adjusting the concentrations of the excipients accordingly.
  • combination variations of these approaches e.g., adjustment of amount, adjustment of concentration
  • the payload of the ingestible device contains a dose of FSH of about 150 IU or about 450 IU, e.g., a dose of FSH (follitropin alfa) of about 150 IU or about 450 IU or a dose of FSH (follitropin beta) of about 150 IU or about 450 IU, or a dose effective to achieve comparable FSH plasma levels with twice daily administration, or a dose effective to achieve comparable FSH plasma levels with twice daily administration and one missed dose.
  • FSH follitropin alfa
  • FSH follitropin beta
  • the present disclosure also provides methods of treating one or more conditions such as infertility in female and male subjects, such as for stimulating follicle development or stimulating ovulation induction in a female patient or treating hypogonadotropic hypogonadism or idiopathic infertility in a male patient (e.g., for stimulation of spermatogenesis), and other conditions for which treatment with FSH may be indicated.
  • Such methods may comprise administering by ingestion to a subject in need thereof an ingestible device as described herein.
  • Microtablets of FSH were manufactured as follows, targeting a dose of 150 IU FSH (follitropin alfa) or 450 IU FSH (follitropin alfa) per microtablet.
  • FSH stability in the microtablets was assessed after 1, 2, and 4 weeks storage at 2-8 °C, and met acceptance criteria (FSH content 80-120% of label claim; oxidation level ⁇ 10%).
  • SC subcutaneous injection of Gonal-F (follitropin alfa) (600 lU/mL) at a dose of 20 lU/kg •
  • Oral oral administration of one ingestible device (capsule) containing a 150 IU or 450 IU FSH (follitropin alfa) microtablet prepared as described in Example 1.
  • Radiographic imaging was used to monitor capsule transit and confirm deployment within the small intestine.
  • blood levels of FSH were assessed pre-dose, and at 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, and 120 hours post-deployment.
  • blood levels of FSH were assessed pre-dose and at 2, 4, 8, 12, 24, 48, 72, 96, and 120 hours post-deployment. Results are reported in FIG. 6 and in the table below (mean ⁇ SEM).
  • the results indicate that FSH dosing of 75 IU twice daily (BID) is comparable to 150 IU once daily (FIG. 7), and that after one missed BID dose FSH plasma levels may fall below once daily levels (FIG. 8).
  • the results also show that FSH dosing of 100 IU twice daily (BID) with one missed dose maintains FSH plasma levels at or above levels provided by 150 IU once daily (FIG. 9).
  • a dose for twice daily administration could be determined that would maintain FSH plasma concentration at a target level even with a missed dose (e.g., as shown for 100 IU BID relative to 150 IU once daily).
  • the ingestible devices as described herein are particularly advantageous in that regard, because a device can be loaded with any desired dose.

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Abstract

La présente divulgation concerne de manière générale des dispositifs ingérables contenant une hormone de stimulation folliculaire (FSH), les dispositifs étant structurés et formulés pour administrer des doses thérapeutiquement efficaces de FSH dans une paroi de lumière gastro-intestinale (GI) ou un tissu environnant de celle-ci (par exemple, le péritoine ou la cavité péritonéale) après ingestion du dispositif, et obtenir des effets pharmacocinétiques et thérapeutiques souhaités.
PCT/US2024/010246 2023-01-05 2024-01-04 Formes pharmaceutique d'hormone de stimulation folliculaire et procédés WO2024148128A1 (fr)

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ALYSON YAMAGUCHI: "Reproductive Endocrinology FRI415 Patient Preference And Proof-of-concept For A Once-daily Follicle Stimulating Hormone (FSH) Biosimilar Delivered Via An Orally Ingestible Robotic Pill (RT-112)", 5 October 2023 (2023-10-05), XP093159717, Retrieved from the Internet <URL:https://watermark.silverchair.com/bvad114.1608.pdf?token=AQECAHi208BE49Ooan9kkhW_Ercy7Dm3ZL_9Cf3qfKAc485ysgAAA4gwggOEBgkqhkiG9w0BBwagggN1MIIDcQIBADCCA2oGCSqGSIb3DQEHATAeBglghkgBZQMEAS4wEQQM9tz7AfrYxIp4X5UcAgEQgIIDO2dgINLzLMxlMys3ZXTo1PWMpZXyLEk-WRkMQJCdePHSITMagmFVpRk_Gq4bTn9LFSlU8ciTMjOmKx0NU-dI8K4> DOI: 10.1210/jendso/bvad114 *
DHALLA ARVINDER K ET AL: "A robotic pill for oral delivery of biotherapeutics: safety, tolerability, and performance in healthy subjects", DRUG DELIVERY AND TRANSLATIONAL RESEARCH, SPRINGER, GERMANY, vol. 12, no. 1, 19 February 2021 (2021-02-19), pages 294 - 305, XP037645571, ISSN: 2190-393X, [retrieved on 20210219], DOI: 10.1007/S13346-021-00938-1 *

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