Rani Therapeutics, LLC

A device includes an inflatable balloon, a reservoir disposed within the inflatable balloon, a needle compartment attached to the balloon and to the reservoir, an injection needle disposed within the needle compartment, and an inflation mechanism. The reservoir contains a therapeutic preparation. The inflation mechanism is structured to inflate the balloon, and upon inflation, the injection needle is structured to enter the reservoir. A method includes making an autoinjector available to a subject with instructions to ingest the autoinjector. The autoinjector is structured to inject a therapeutic preparation into a wall of a gastrointestinal tract of the subject responsive to ingestion of the autoinjector. The autoinjector includes an injection needle disposed in a needle compartment attached to a reservoir. The injection needle is initially separated from the reservoir, and is structured to enter the reservoir for delivery of the fluid therapeutic preparation through the needle into the wall.

Embodiments of the invention provide shaped masses comprising one or more drugs such as proteins or polypeptides and methods for forming such shaped masses. One embodiment provides a shaped mass comprising a drug such as a protein or polypeptide having a biological activity in the body of a mammal. The shaped mass is formed by compression of a precursor material comprising the drug wherein an amount of biologically active drug in the mass is a preserved above a minimum level. Drugs which may be incorporated into the shaped mass may include one or more glucose regulating proteins such as insulin, incretins; and immunoglobulins such as TNF-inhibiting antibodies or interleukin neutralizing antibodies. Embodiments of the shaped mass may be incorporated into a tissue penetrating member which is inserted into the intestinal wall allowing for the oral delivery of proteins and peptides which would otherwise be degraded in the intestinal tract.

The present disclosure relates generally to ingestible devices containing anti-interleukin antibodies that bind to one or both of human interleukin-23 and human interleukin-12, such as ustekinumab, wherein the devices are structured and formulated to deliver therapeutically effective amounts of the antibodies into a gastrointestinal (GI) lumen wall or into and through a GI lumen wall into a peritoneum or peritoneal cavity after ingestion of the device, and achieve desired pharmacokinetic and therapeutic effects.

Embodiments provide devices, preparations and methods for delivering therapeutic agents (TAs) such as clotting factors (CFs, e.g., Factor 8 ) within the GI tract. Many embodiments provide a swallowable device e.g., a capsule for delivering TAs into the intestinal wall (IW). Embodiments also provide TA preparations configured to be contained within the capsule, advanced from the capsule into the IW and/or surrounding tissue (ST) and degrade to release the TA into the bloodstream to produce a therapeutic effect (e.g., improved clotting). The preparation can be operably coupled to delivery means having a first configuration where the preparation is contained in the capsule and a second configuration where the preparation is advanced out of the capsule into the IW or ST (e.g., the peritoneal cavity). Embodiments are particularly useful for delivery of CFs for treatment of clotting disorders (e.g., hemophilia) where such CFs are poorly absorbed and/or degraded within the GI tract.

Embodiments provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Particular embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. Embodiments also provide various drug preparations that are configured to be contained within the capsule, advanced from the capsule into the intestinal wall and degrade within the wall to release the drug to produce a therapeutic effect. The preparation can be coupled to a delivery mechanism having one or more balloons or other expandable devices which are expandable responsive to a condition in the small intestine or other GI lumen to advance the preparation out of the capsule into the intestinal wall. Embodiments are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.

Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Some embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. The device comprises a capsule sized to be swallowed and pass through the intestinal tract. The capsule can include at least one guide tube, one or more tissue penetrating members positioned in the guide tube, a delivery member, an actuating mechanism and a release element. The release element degrades upon exposure to various conditions in the intestine so as to release and actuate the actuating mechanism. Embodiments of the invention are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.

Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Particular embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. Embodiments also provide various drug preparations that are configured to be contained within the capsule, advanced from the capsule into the intestinal wall and degrade within the wall to release the drug to produce a therapeutic effect. The preparation can be coupled to a delivery mechanism having one or more balloons or other expandable devices which are expandable responsive to a condition in the small intestine or other GI lumen to advance the preparation out of the capsule into the intestinal wall. Embodiments of the invention are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.

An ingestible device for delivering a therapeutic preparation into a lumen wall or a surrounding tissue of a gastrointestinal (GI) tract of a subject includes an enclosure, a support, an arm, a delivery assembly, an extender, an actuator, and a release. The support is disposed in the enclosure and defines a longitudinal axis of the device. The delivery assembly includes a delivery structure coupled to the arm, and a therapeutic preparation disposed in the delivery structure. The extender is coupled to at least one of the support or the delivery assembly. The extender is structured to extend along the longitudinal axis to substantially align the delivery structure relative to the lumen wall. The actuator is coupled to the delivery assembly. The release is coupled to the actuator and is activated in response to a condition in the GI tract to cause actuation of the actuator. When the release is activated, the actuator causes the arm to pivot relative to the support such that the delivery assembly extends outwardly away from the longitudinal axis toward the lumen wall to deliver the therapeutic preparation from the delivery structure into the lumen wall or surrounding tissue.

A delivery assembly for an ingestible device for delivering a fluid preparation into a GI lumen wall or surrounding tissue of a subject includes a housing, a piston-needle assembly, a membrane, and a valve member. The housing defines a chamber. The piston-needle assembly is movably disposed in the chamber and includes an inlet and a channel. The membrane is coupled to the housing such that the membrane and the housing cooperatively define a reservoir for containing the fluid preparation. The housing further defines an opening extending between the chamber and the reservoir. In response to sufficient movement of the piston-needle assembly relative to the housing, the valve member opens to allow the fluid preparation to flow from the reservoir through the opening into the chamber where the fluid preparation is directed to the inlet and the channel for delivery into the GI lumen wall or surrounding tissue thereof.

A delivery assembly for an ingestible device to deliver a fluid preparation into a GI lumen wall or surrounding tissue of a subject includes a housing, a piston, a needle, a conduit, and a valve member. The housing defines a piston chamber. The piston is movably disposed in the piston chamber. The needle is coupled to, or integrally formed with, the piston. The conduit is structured to direct the fluid preparation from a fluid source to the needle. The valve member has a first state and a second state. In the first state, the valve member substantially impedes a flow of the fluid preparation from the conduit to the needle. In the second state, the valve member is structured to allow the fluid preparation to flow through the conduit to the needle.