Discussion Group Report

Oral Biologics Discussion Group Report

By Oliver Picken |
23 November 2021
This September, our formulation series discussion group focused on the delivery of oral biologics. Biologic-based therapies have soared in popularity and now account for approximately 12% of the pharmaceutical market.

Oxford Global’s discussion groups bring together a select group of 15-20 key industry leaders for approximately one hour.  

This September, our formulation series discussion group focused on the delivery of oral biologics. Biologic-based therapies have soared in popularity and now account for approximately 12% of the pharmaceutical market. Hundreds of biologics have been approved for a wide range of conditions, including cancer. It is estimated that around 40% of drugs currently in trials and development drugs are biologics. Oral delivery of biologics has long been a subject of interest, but it has not proved easy to create efficacious drugs. 

Patrick Garidel (Head of Process Development and Pharma Development, Boehringer Ingelheim) opened this month’s discussion group proceedings with an introductory presentation titled “Oral Delivery of Biologics – Quo Vadis?”. Some of the key topics covered included the successes and failures of oral biologics, novel delivery methods and the difficulties of overcoming biological barriers.  

Joining Patrick to foster discussion were Shawn Davis (Head of Drug Delivery, Biopharmaceuticals Development, R&D, AstraZeneca), Joel Richards (Chief Technology Officer, Medincell) and Robert Niichel, (Founder & Chief Executive Officer, SmartTab). 

Bioavailability: Overcoming Oral Delivery Barriers 

One of the most significant issues facing oral biologics is poor bioavailability compared to standard practices such as injection. Bioavailability is the percentage of a dose that reaches the bloodstream, typically expressed as a percentage. When delivered orally, proteins have extremely low bioavailability, usually less than 1%. This is because their half-life is relatively short, and their ability to permeate through the patient’s gastrointestinal walls is inadequate. Shawn Davis points out that “when you have low bioavailability, you’re probably taking pills a lot more frequently than you’re going to be giving yourself an injection for many of these therapies.” 

Low bioavailability has been an economic barrier to oral biologics as to get the same therapeutic effect to other methods requires far higher quantities of the same active ingredients. However, with that said, costs for large-scale production of biologics have come down significantly in the last few years. In addition, the fact that only a portion of the payload is delivered across the gut is becoming less of a problem as larger doses become more economically viable.  

Macro of background made from pills and capsules, example of oral biologics

Patient Centricity: Improving Compliance and Comfort 

Most biologics are delivered by intravenous or subcutaneous injection, which is practical but not desirable for patients. In addition, these medicines are occasionally self-administered by trained patients but more often require healthcare staff and practice visits. Alternative administration of such drugs through oral delivery would eliminate the need for such visits while being far more comfortable for the patient.  

Robert Niichel states that patient focus groups have shown that “there seems to be a large demand to move away from the self-injections.” Furthermore, he believes that oral delivery has the potential to increase patient compliance, saying that “We believe that if you could take an oral capsule once a week that matches the effect on an injection, we can obtain very high compliance.” 

Exploring Novel Delivery Systems 

Many technologies have been created to boost the delivered dose of orally delivered biologics, including enzyme inhibitors, absorption and permeation enhancers, adhesive and carrier molecules. However, despite this extensive toolset, most oral biologics have failed in trials due to viability. 

One example of an orally delivered biologic drug is linaclotide. This drug targets receptors within the stomach, which reduces the need for costly and complex enhancements. Another novel technique for developing oral biologics includes pills that are embedded with medicine-containing microneedles. They work by implanting themselves in the intestine lining and enabling the drug to penetrate the mucosal and epithelial walls. While the idea of swallowing needles may sound dangerous, Robert Niichel explains that “the stomach is a very robust environment. The stomach gets nicked all the time; whether it’s something you eat or something else, it heals very fast. Beyond that, being a robust area, our needles are very small. The solid state is 0.5 millimetres; the liquid state is even smaller. So, you’re making a very small injection hole into the bottom of the stomach that heals very quickly.” 

Conclusion 

The discussion group concluded with a debate around when oral delivery should be explored as an option and optimism due to the increasing amounts of data available to base decisions on. Oral delivery faces some difficult biological barriers to overcome but the potential for greater compliance and patient centricity are driving innovation in novel delivery systems.   

At Oxford Global, we couldn’t have been more pleased with the turnout for our first ever Formulation & Delivery discussion group. The conversation was engaging, the debate stimulating, and the event provided the perfect setting for exchanging ideas.  

We will continue our monthly discussion group series next month when we focus on Inhaled Biologics. Learn more about Oxford Global’s discussion group series and our other events here. 

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