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Basking Biosciences Doses First Patients In Phase 2 Clinical Trial Of Reversible Thrombolytic BB-031 For Acute Ischemic Stroke

Novel RNA aptamer designed to inhibit the function of von Willebrand Factor and promote thrombolysis

COLUMBUS, Ohio, September 10, 2024--(BUSINESS WIRE)--Basking Biosciences (Basking), a clinical-stage biopharmaceutical company developing a novel acute thrombolytic therapy, today announced that the first patients have been dosed in RAISE, a Phase 2 clinical trial evaluating BB-031 in patients presenting with acute ischemic stroke (AIS).

"We are excited to announce the initiation of patient enrollment in the RAISE trial," said Richard Shea, Chief Executive Officer of Basking. "This milestone brings us closer to delivering a next-generation therapy that we believe will offer patients a new targeted thrombolytic option beyond traditional fibrinolytics."

RAISE is a two-part, Phase 2 clinical trial designed to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of BB-031 in 156 patients with acute ischemic stroke who present within 24 hours of onset. The trial is a multicenter, double-blind, placebo-controlled, randomized single ascending dose study. For additional trial details, see clinicaltrials.Gov.

"Effectively and safely targeting recanalization of acutely occluded intracranial arteries with novel pharmacology has the potential to expand access to treatment for stroke patients and will address a significant unmet need in acute stroke care," said Michael Hill, M.D., Professor for the Departments of Clinical Neurosciences, Community Health Sciences, Medicine and Radiology at the University of Calgary and Foothills Medical Centre, and Clinical Program Advisor and Principal Investigator of RAISE. "Many patients are simply not eligible for current drug treatments or cannot reach a comprehensive stroke center in time to benefit from advanced endovascular treatment."

"We are thrilled to have this study underway – patients are waiting," said Shahid M. Nimjee, M.D., Ph.D., co-founder, Chief Medical Officer of Basking, and Professor of Neurosurgery and Surgical Director of the Comprehensive Stroke Center at The Ohio State University Wexner Medical Center. "We believe BB-031 will greatly expand the therapeutic options for stroke patients. Recanalization may also be performed more safely given that our reversal agent, BB-025, which will enter clinical development next year, has been shown in preclinical studies to neutralize BB-031 within minutes."

About Acute Ischemic Stroke

Acute Ischemic Stroke (AIS) is the leading cause of combined mortality and morbidity worldwide, and 87% of all strokes are ischemic. According to WHO, 15 million people suffer strokes each year, leading to more than 5 million deaths. Global incidence is rising with aging populations. In high-income countries alone, annual direct stroke-related medical costs plus indirect costs due to premature mortality and loss of productivity are projected to exceed $826 billion by 2050. While intravenous recombinant tissue plasminogen activators (alteplase, tenecteplase) and endovascular mechanical thrombectomy are available to treat acute ischemic stroke, either or both treatments can only be applied to a ceiling of 20% of all ischemic stroke patients even in the best centers worldwide. Among ischemic stroke patients, 80% or more do not receive acute intervention.

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About Basking Biosciences

Basking Biosciences, a clinical-stage biopharmaceutical company, was founded to solve the biggest need in acute thrombosis – for a rapid-onset, short-acting thrombolytic drug capable of reopening blocked arteries, and whose activity can be quickly reversed in the event of a bleeding complication. Leveraging RNA aptamer technology, our lead drug candidate, BB-031, targets von Willebrand Factor (vWF), an important structural component of blood clots and driver of the clotting process, and is designed to be safer, more effective, and able to significantly expand the population receiving acute revascularization therapy.

For more information, visit BaskingBiosciences.Com and follow us on LinkedIn.

View source version on businesswire.Com: https://www.Businesswire.Com/news/home/20240910196771/en/

Contacts

Susan SharpeLinnden Communicationssusan@linndencom.Com

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What Is Acquired Von Willebrand Disease (AvWD)?

Acquired von Willebrand disease (AvWD) is a type of von Willebrand disease (vWD) that isn't inherited. Instead, it can be due to other medical conditions or certain medications.

vWD is a condition of the blood that slows the clotting process. It's usually inherited, but people can also develop it secondary to a different condition. This is called AvWD.

Both genetic and acquired vWD are uncommon. The genetic form affects fewer than 200,000 people in the United States, but estimates are as high as 1 in 100 because those with mild symptoms might not have diagnoses. AvWD is even more uncommon.

vWF is a type of cellular protein that's critical to blood clotting. It forms a bridge between platelets and the lining of blood vessels. When vWF doesn't work properly, this bridging is slow to occur, and blood is slow to clot.

In genetic vWD, vWF doesn't work properly because of an inherited genetic difference. In type 3 vWD, vWF is missing completely. In AvWD, the problems with vWF function are because of another condition, like an autoimmune condition.

With the acquired form of the condition, vWF works effectively to support blood clotting until the secondary condition disrupts its normal function. How this happens depends on the underlying condition. One example is myeloproliferative disorders, which are types of blood cancers. They cause the immune system to develop antibodies against vWF.

Doctors diagnose genetic vWD based on the amount of vWF in the blood, though no one test is conclusive. Typically, doctors don't test if there's no personal history of bleeding or no family history of vWD or a bleeding condition. There are detailed guidelines about how to test for specific types of genetic vWD.

There's no specific diagnostic procedure for AvWD. Doctors diagnose it through laboratory findings and symptoms that look like the genetic form of vWD.

If a person has gastrointestinal bleeding, a doctor might use endoscopy to examine the gastrointestinal tract to search for other causes, like polyps, ulcers, or cancer. If there's no other cause, they might look to a malfunction of vWF as the cause.


Nederlandse Kooikerhondje: Breed Profile

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Active, affectionate, and easy to train; the Nederlandse Kooikerhondje makes the perfect canine companion. This lively little breed originates from the Netherlands and the name is pronounced 'ney-der-lan-dsuh koy-ker-hoon-tyeh' (or 'koy-ker' for short).

This breed has been around since the 16th century and was originally bred to help hunters catch ducks. Thanks to their intelligence, confidence, and responsive nature, they make excellent working dogs, and they are still used by hunters today.

If you're thinking about getting a Kooikerhondje, they require lots of mental and physical stimulation, so you'll need the best dog toys to keep them entertained and happy. Below, we've revealed everything you need to know about this beautiful red-and-white breed.

Nederlandse Kooikerhondje breed profile. Height: 15-17

Are Nederlandse Kooikerhondjes easy to train?

Yes, Nederlandse Kooikerhondjes are easy to train — especially when they're rewarded with the best dog treats! Ruth Mollema, an expert at Pets4Homes, explains that this breed is known for being quite trainable when they're approached with patience and a gentle touch.

She says: "They're smart dogs who pick up commands quickly, but they do best with positive reinforcement - think treats, play, and lots of praise. They can be a bit sensitive and even a little stubborn at times, so staying consistent and keeping things fun makes a big difference."

Positive reinforcement for dogs is when you reward the desired behavior, as opposed to punishing the 'bad'; encouraging your dog to repeat the good in the future. This can be done using toys, food, or praise and is the most effective training method.

What temperament and personality do Nederlandse Kooikerhondjes have?

Kooikerhondjes are lively and affectionate with heaps of personality, explains Ruth. They have a sensitive side which means that when you first meet them, they might be a little bit reserved until they get to know you. However, once they're comfortable and feel they can trust you, they're "friendly and loyal for life".

Ruth says: "They're alert and curious, which comes from their background as working dogs, so they like being engaged and having a job to do - whether that's a fun game, training, or exploring."

If you decide to bring home a Kooikerhondjes, these eight fun games to play with dogs will keep their brain ticking. You might also want to read our guide on how to play with a dog.

Nederlandse Kooikerhondje running towards the camera

Are Kooikerhondjes good with children?

If you have children, choosing the right dog breed is a big decision. Due to their gentle and affectionate nature, Kooikerhondjes can be great with children when they've been brought up together.

However, Ruth says: "Because they are a bit sensitive, they might not appreciate rough play or too much noise. If kids are taught to interact with them respectfully, these dogs usually do well and can form strong bonds with younger family members."

You might also want to consider these friendliest dog breeds.

Do Nederlandse Kooikerhondjes shed alot?

Ruth explains that whilst Kooikerhondjes do shed, it's not excessive, so you won't have to worry too much about hairs around your home. Their coat is medium-length and sheds moderately all year round, but this is more noticeable during the spring and fall, she says.

To keep their fur healthy and under control, Ruth recommends brushing them regularly. Not only will this keep their coat in tip-top condition and prevent uncomfortable matting, but it's also one of the 32 ways for improving your relationship with your dog. If you're a first-time dog owner, we've created a guide on the best dog brushes to make grooming easier.

Hertzko Self Cleaning Slicker Dog BrushThis slicker brush is great for detangling medium-length fur and will keep it looking healthy. The retract button makes it easy to clean, and it has an ergonomic design that's comfortable to hold.View Deal

Do Nederlandse Kooikerhondjes bark a lot?

Kooikerhondjes are naturally alert and tend to be vocal when they notice something unusual, explains Ruth. So, if you're looking for one of the quietest dog breeds, they might not be the right fit for you.

Ruth says: "They're likely to bark to let you know if a stranger is near or if something catches their attention. While they can be a bit barky, this trait can be managed with training. Early socialization and teaching them when it's appropriate to be quiet can help tone down excessive barking."

If your dog won't stop barking and you need a helping hand, our vet has written a brilliant guide on how to train them out of it and why they might be doing it excessively.

Nederlandse Kooikerhondje standing on a dried grass field

Nederlandse Kooikerhondjes health problems

Kooikerhondjes are a fairly healthy breed with good longevity, according to vet Dr. MacMillan. However, since they're not very common and have a relatively small gene pool, this means that they can have inherited health problems such as the following:

Von Willebrand's diseaseDr. MacMillan says: "Von Willebrand's disease is a clotting disorder that can be passed down family lines in Nederlandse Kooikerhondjes. These dogs are deficient in a clotting factor called Von Willebrand factor, meaning they bleed abnormally and much more severely than a healthy dog. This can become apparent if your dog becomes injured or when they have routine surgery, like neutering."

Patella luxation Patella luxation is also common in Kooikerhondjes, and is where the dog's affected kneecap pops out of place. Dr. MacMillan says the severity can vary, but some dogs might need surgery if it causes painful lameness. Restlessness, shaking and decreased activity are some of the signs a dog is in pain.

Hereditary necrotizing myelopathy (ENM) Dr. MacMillan says: "Hereditary necrotizing myelopathy (ENM) is a spinal disease that is still being investigated, as there is currently no cure. Signs can start around three to 12 months of age leading to paralysis in the hind legs. Sadly, affected Nederlandse Kooikerhondjes will die of this disease."

Eye abnormalities Kooikerhondjes might also have eye abnormalities like cataracts and retinal dysplasia, explains Dr. MacMillan. Pedigree dogs are more likely to inherit these problems as their gene pool isn't as diverse.

Nederlandse Kooikerhondje dog in front of purple flowers

What health checks are reccomended for Nederlandse Kooikerhondjes?

If you're thinking about getting a Kooikerhondje, Dr. MacMillan recommends the following:

  • Buy from a reputable breeder: This reduces the risk of getting a dog with an inherited disease.

  • Take a test: You can buy DNA tests that detect myelopathy (ENM) and Von Willebrand's disease. She says: "Dogs that are found to be carriers of these conditions should not be bred. Breeding dogs can also be screened for heritable eye diseases to reduce the risk of them passing on issues to their offspring."

  • Attend regular vet check-ups: As well as visiting your vet regularly, you should keep an eye on your dog for lameness and bleeding abnormalities.

  • Enjoyed this? You might also want to learn about labrador retrievers and cavalier King Charles spaniels.






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