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公开(公告)号:WO2020146640A1
公开(公告)日:2020-07-16
申请号:PCT/US2020/012942
申请日:2020-01-09
Applicant: SPIRAL THERAPEUTICS, INC.
Inventor: HERRERO, Carmen , AYOOB, Andrew , HANES, Justin , PERIS, Hugo
Abstract: A solution for sustained release of therapeutic, prophylactic and/or diagnostic agent in the inner ear has been developed. The formulation can be injected through a small gauge needle into the inner ear, where it gels to form a sustained release depot for controlled delivery of drug over a few days. In the preferred embodiment, the formulation includes a thermoresponsive sol-gel polymer such as POLOXAMER 407 which forms a stable hydrogel after trans-tympanic injection. As demonstrated by the examples, the hydrogel provides sustained release of an apoptosis inhibitory agent, LPT99, an anti-apoptosis agent that inhibits apoptotic protease activating factor 1 (APAF-1), as well as safety and efficacy in in vitro and in vivo models.
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公开(公告)号:WO2021163610A1
公开(公告)日:2021-08-19
申请号:PCT/US2021/018019
申请日:2021-02-12
Applicant: SPIRAL THERAPEUTICS INC. , DE JUAN, Eugene , AYOOB, Andrew , ERICKSON, Signe , FARINAS, Kathleen
Inventor: DE JUAN, Eugene , AYOOB, Andrew , ERICKSON, Signe , FARINAS, Kathleen
Abstract: Active agents that bind to VEGF or a VEGF receptor and reduce the severity of a condition associated with BLB disruption and/or angiogenesis, for example anti-VEGF antibodies or tyrosine kinase inhibitor small molecules, can be locally, regionally or systemically administered to an individual with an otic disease or condition, such as Ménière's Disease, Autoimmune Inner Ear Disease, sensorineural hearing loss and noise-induced hearing loss, to alleviate symptoms of the disease or condition, for example, due to edema and endolymphatic dysfunction. An effective amount of these compounds can be delivered by intratympanic or intracochlear administration. Other methods of administration include, but are not limited to, topical, parenteral, subcutaneous, intraperitoneal and intranasal. Formulations may be, for example, for immediate release, sustained release, or controlled release.
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公开(公告)号:WO2021150894A2
公开(公告)日:2021-07-29
申请号:PCT/US2021/014618
申请日:2021-01-22
Applicant: SPIRAL THERAPEUTICS INC.
Inventor: DE JUAN, Eugene , ERICKSON, Signe , LIMB, Charles , PERIS, Hugo , AYOOB, Andrew , LEVERING, Vrad
IPC: A61F11/00 , A61F2/18 , A61B1/018 , A61B1/227 , A61B17/29 , A61B17/320068 , A61B17/3205 , A61B17/3423 , A61B17/3468 , A61B17/3478 , A61B18/04 , A61B18/1485 , A61B18/20 , A61B2017/00115 , A61B2017/00323 , A61B2017/00331 , A61B2017/00787 , A61B2017/00867 , A61B2017/32007 , A61B2017/345 , A61B2018/00327 , A61B2217/005 , A61F11/002 , A61F11/004 , A61F2/958 , A61F2002/183 , A61F2250/0067 , A61M2037/0023 , A61M2037/0046 , A61M2205/04 , A61M2210/0662 , A61M2210/0668 , A61M31/00 , A61M31/002 , A61M37/0015 , G02B21/0012 , G02B21/0032 , G02B21/22
Abstract: Systems and methods can be employed for trans-tympanic membrane access to the middle ear for delivery of a therapeutic agent, for example, to the round window niche adjacent to the cochlea under direct visualization. The systems and methods can also be used to improve accessibility and visualization for various otological surgical procedures, such as, but not limited to, cholesteatoma removal, tympanic membrane repair and ossicular chain repair.
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公开(公告)号:WO2020176419A1
公开(公告)日:2020-09-03
申请号:PCT/US2020/019517
申请日:2020-02-24
Applicant: SPIRAL THERAPEUTICS, INC.
Inventor: SACHERMAN, Kevin W. , AYOOB, Andrew , ERICKSON, Signe , PERIS, Hugo , LIMB, Charles , DE JUAN, Jr., Eugene
Abstract: A system for delivering one or more therapeutics to a region of the ear, the region being internal to a tympanic membrane. The system includes a canal guide configured to be inserted within and fittingly engaged with walls of the ear canal and needle assembly having a flexible shaft sized to extend through the canal guide. The canal guide provides alignment of the needle assembly within the ear canal relative to the tympanic membrane. The canal guide includes a viewing lumen extending between a proximal end to a distal-most end of the canal guide and is sized to remain external to the tympanic membrane. The canal guide includes a guide lumen extending to a distal opening near the distal-most end of the canal guide. The guide lumen curves from a first axis to a second axis. Related devices, systems, and methods are provided.
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公开(公告)号:WO2021150858A1
公开(公告)日:2021-07-29
申请号:PCT/US2021/014561
申请日:2021-01-22
Applicant: SPIRAL THERAPEUTICS INC.
Inventor: DE JUAN, Eugene , ERICKSON, Signe , LIMB, Charles , PERIS, Hugo , TALREJA, Nikhil , AYOOB, Andrew
IPC: A61F11/00 , A61B1/018 , A61B1/227 , A61B17/29 , A61B17/320068 , A61B17/3205 , A61B17/3423 , A61B17/3468 , A61B17/3478 , A61B18/04 , A61B18/1485 , A61B18/20 , A61B2017/00115 , A61B2017/00787 , A61B2017/00867 , A61B2017/32007 , A61B2018/00327 , A61B2217/005 , A61F11/002 , A61F11/004 , A61F2/958 , A61F2002/183 , A61F2250/0067 , A61M2037/0023 , A61M2037/0046 , A61M2205/04 , A61M2210/0662 , A61M2210/0668 , A61M31/00 , A61M31/002 , A61M37/0015 , G02B21/0012 , G02B21/0032 , G02B21/22
Abstract: Intra-tympanic injections of therapeutics into the inner ear can be used to treat conditions such as hearing loss. One or more stabilizing devices that define working channels can be temporarily implanted in the tympanic membrane. Purpose-built instruments such as endoscopes, forceps, and injections instruments can be passed through the working channels of the stabilizer devices to access the inner ear where the therapy can be administered. Afterwards, the stabilizing devices can be removed from the tympanic membrane and the tympanic membrane can heal, typically without the need for sutures.
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公开(公告)号:WO2021231563A1
公开(公告)日:2021-11-18
申请号:PCT/US2021/031977
申请日:2021-05-12
Applicant: SPIRAL THERAPEUTICS INC. , DE JUAN, Eugene , ERICKSON, Signe , AYOOB, Andrew , FARINAS, Kathleen
Inventor: DE JUAN, Eugene , ERICKSON, Signe , AYOOB, Andrew , FARINAS, Kathleen
Abstract: Provided herein are polymer compositions and extended release otic agents. In one aspect, provided herein is a polymer composition including about 5% to about 15% by weight of the polymer composition of a functional polymer, wherein the functional polymer includes a first functional group, about 0.05% to about 0.6% by weight of the polymer composition of a crosslinker, wherein the crosslinker includes a second functional group, and water, wherein a crosslinking reaction can occur between the first functional group and the second functional group to form a gel, and wherein the polymer composition has a gelation time of about 45 seconds to about 60 minutes at a temperature of about 20 °C.
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