By Ed Miseta, Editor-in-Chief, Clinical Leader
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If you say that Lyndra Therapeutics makes a range of treatments based around an extended release capsule, don’t be surprised if someone from the company corrects you. To call their technology an extended-release capsule is a gross understatement.
“We’re not just extending the publication,” says Dr. Patricia Hurter, President and CEO of Lyndra. “Other companies have been doing this for decades. We enable patients to take their medication once a day instead of several times a day, or once a month instead of daily, in the form of an oral dose. Our tablet could stay in a patient’s stomach for several days, slowly releasing their treatment. Nobody has done that yet. “
This approach has two advantages. For other treatments, patients take a product that their body usually absorbs within three hours. In patients who need relief over time, their bodies will receive too much of the drug when they take it and too little of it later as it metabolizes and wears off.
The other problem with traditional treatments is lack of drug compliance. Effective drugs are available for diseases such as diabetes, high blood pressure, and cardiovascular disease, but many patients, intentionally or unintentionally, do not adhere to the regimen. According to the CDC, approximately 70% of American adults have at least one chronic illness and 50% of chronic disease medications are not taken as prescribed. Medication failure compliance is now a $ 300 million problem in the US alone.
“Our capsule can stay in a patient’s stomach as long as we want,” says Hurter. “The drug is gradually released over time and eventually cleared from the body at the end of the dosing period. Long-lasting medications were usually patches, implants, and injections. While these products play a role, most patients would prefer to swallow a pill. That is a unique advantage of our technology. “
Avoid costly delays
Lyndra could apply its technology to almost any treatment. But like most drug development companies, it is faced with limited resources. Because of this, the company wants to apply it where it will bring the greatest benefit to patients. One of these areas is neuroscience.
“When the brain is diseased, someone else is usually involved,” says Hurter. “When we think of a disease like schizophrenia, these patients need help to keep up with their therapies. Generally, they will be reminded of this by a parent or sibling, and psychiatrists have told us that it creates poor dynamic in these relationships. The daily memories are often perceived as disrespectful or nagging. ”
Since it is important for patients to take their medications, it is critical that they need to be taken less often. Hurter points out that Alzheimer’s disease is another area that the Lyndra product can help, as it would require fewer reminders from family members about medication adherence.
Lyndra is also testing its technology in other areas. The company has filed for five INDs in the past 18 months and is investigating the use of its extended-release capsule in cardiovascular and metabolic disease, HIV, malaria and women’s health.
A focus on security
While that number of studies may seem like a lot for a small business, Dr. Richard Scranton, CMO of Lyndra, shared the company’s agile and adaptable approach to conducting clinical trials. The company has experienced researchers, but Scranton credits the company’s success to the deep relationships Lyndra has with its study partners, especially its CROs.
“We have good, ongoing relationships with our CROs and work closely with our investigators in Australia,” he says. “We have a master’s protocol that is used across multiple studies and allows us to introduce changes to our platform and conduct studies very quickly.”
While some studies were shut down in 2020 due to the pandemic, Lyndra had already put COVID protocols in place. As a result, patients felt safe to participate in the studies, and Scranton notes that Lyndra was able to continue her work without any delays.
“Australian regulators have a very flexible approach to drug development,” added Hurter. “The hurdle to start studying there is much lower, as the requirements for acquiring an IND are less strict than in other parts of the world. There were also overall cost benefits, including tax benefits, to conduct studies there. These factors make it a very attractive place to conduct studies. “
Trustworthy and flexible partner
RedHill takes a slightly different approach to CRO partner selection than many sponsors. The most important factors Scranton looks for when selecting a CRO are flexibility and willingness to work as part of the in-house clinical team.
“We need a CRO who understands our business, can adapt flexibly to our needs and doesn’t want to bill us for every question we have,” explains Scranton. “When you’re a small business, drug development is a team effort and we need that mentality in our CRO. Unfortunately, these properties can be very difficult to find. “
For the work Lyndra does in Australia, Scranton notes that Novotech and Worldwide Clinical Trials are preferred partners. The company also works with Syneos Health. While these aren’t the biggest names in the CRO space, Scranton notes that each company was big enough to have the core competencies and willingness to make connections for required skills that the CRO did not have.
“Some have regional expertise in areas like Asia or Australia,” he says. “We have found this expertise to be helpful in conducting our studies. These vendors also had existing relationships with the lead investigators that we worked with which was very helpful. They also had contacts with other companies unknown to us and were ready to make recommendations. When they didn’t have the resource we needed, such as imaging, we trusted them to connect with a company that did. “
Speed study startup
The start of studies is critical to Lyndra, and Scranton notes that sometimes the start of studies has to be postponed for a week or two. In this case, the flexibility of the partners comes into play so that the two weeks don’t turn into two months. He can rely on his CROs and locations to accommodate him and still attract patients promptly. When that happens, he feels like Lyndra, its locations and CROs are all one company working towards a common goal.
Another decision that worked well for the company was the decision to build its own GMP manufacturing facility to supply all of the research and development material for clinical trials. Hurter notes that the company’s technology is so unique that outsourcing manufacturing would not be beneficial.
“We knew we were essentially buying the equipment needed for the manufacturing process, and buying that equipment for another company wasn’t much for us,” says Hurter. “That’s why we decided to build it ourselves. This decision has paid off for us because if we didn’t have a facility of our own, I think we would have had major delays last year when the pandemic broke out. We were very aggressive in our manufacture and I’m not sure if other CMS would have been that aggressive in their approach to dealing with COVID. “
Lyndra had no work-related transmissions of COVID and was able to provide all of the material needed for his studies.
Although the tests went smoothly, Lyndra had challenges to overcome. The company conducted multiple studies at the same time and even ended two studies at the same time. This forced Lyndra to work aggressively with the sites on its Phase 1 / Phase 2 studies to ensure that they are safe for patients. Lyndra was ahead of the curve when she incorporated remote monitoring into her attempts. Hurter believes the company’s ability to recruit patients so quickly has to do with making patients feel safe participating in the study.
This innovation will continue even after Covid. Lyndra will incorporate continuous glucose monitoring into a diabetes study. An addiction disease study is testing wearable devices to assess patients wherever they are.
“Lyndra’s mission is to reinvent medicine for a healthier world,” added Hurter. “To this end, we will continue to act very flexibly, openly and globally. We don’t want to do anything the traditional way. We live in interesting times and will continue to be creative and global in the development of new drugs. “