PECTIN’S PROMISE
Grads help harness apple byproduct’s healing power By Jeff Holmquist
wo USAFA graduates are on the front line in the battle against irritating skin disease. Maj. Simon Ritchie ’03 and Maj. Casey Bowen ’04 — both Air Force dermatologists stationed in Texas — have partnered with pharmaceutical company Galectin Therapeutics to conduct research on a new treatment that shows great promise against severe cases of psoriasis and eczema. The new drug (GR-MD-02) was initially developed to address a serious liver disease — Non-Acoholic Steatohepatitis or NASH (fibrosis or cirrhosis of the liver that is not the result of alcohol abuse). The drug is derived, in part, from apple pectin — a powdery substance extracted from the pulp of apples and other fruits. During the clinical trials on several hundred patients with liver disease, one patient who also had a severe case of psoriasis told doctors that her skin disease started clearing up after taking the experimental medication. “That was very significant, in my opinion as a dermatologist, because psoriasis doesn’t just get better,” Ritchie explains. “It doesn’t just go away.” Interestingly, drugs targeting one disease can often end up being effective against other health problems, according to Ritchie. GR-MD-02 appears to be one such promising drug. “We kind of know, as investigators, to always ask about a patient’s other health problems,” he says. “Sometimes it’s just by happenstance that we figure out how things work. We’ve seen some major breakthroughs that way.”
Clinical Trial
Since Galectin Therapeutics remains focused on finding effective treatments for liver disease, the company asked Ritchie if he’d be willing to conduct a separate drug trial on psoriasis patients. (Pso58 · usafa.org
riasis is a chronic inflammatory skin disease and between 2 and 3 percent of the U.S. population suffers from the malady. Psoriasis also can affect the joints and pre-dispose people to other risks — heart attacks, strokes and diabetes.) The USAFA grad agreed to help out and recruited five individual patients to participate. After establishing a medical baseline for each patient — recording measurements for height, weight, physical fitness, severity of the disease, etc. — the research began. Every two weeks, the patients visited Ritchie’s clinic and received a dose of GR-MD-02 — higher dosages for heavier patients and lower levels for smaller patients. After completing 13 infusions over six months, Ritchie concluded the initial trial. Even though Ritchie was skeptical about the new drug when he started the trial, he’s now optimistic that GR-MD-02 will relieve the pain and irritation psoriasis patients suffer with every day.
Promising Results
The severity of each patient’s psoriasis is measured by a Psoriasis Area Severity Index (PASI) score, Ritchie explains. By the end of the trial, the average patient in Ritchie’s clinical trial showed a 50 percent improvement in their PASI score. One patient — who was the heaviest patient in the trial and thus received the highest dosage of GR-MD-02 — realized an 80 percent improvement in his skin condition. “He was essentially clear,” Ritchie reports. “We have photos that are just jaw dropping. They are absolutely striking.” Some of the patients who stopped the drug infusions have since reported that their psoriasis has not returned, even though many months have passed since the trial ended. “I would never, ever say that we’re going to cure psoriasis,” he says. “But we may be able to induce a remission. That would be Checkpoints · June 2017 · 59
an incredible advantage to the patient, to the insurance company that’s paying for the medicine, to the physicians, and to access to care. It would be an all-around benefit.” Another positive sign from the clinical trial was the lack of side effects reported by patients taking the drug, Ritchie reports. Many psoriasis treatment drugs on the market today suppress a patient’s immune system or can cause serious side effects. “Hundreds of patients have received this drug and not a single person has had an adverse event related to the drug,” he notes. “That’s very, very significant.” The fact that the drug is derived from a polymer of sugar molecules — apple pectin — likely has something to do with the lack of negative outcomes, Ritchie suggests. “Drugs based on sugar molecules, rather than the typical organic chemicals or proteins, may have fewer side effects,” he says. The good news doesn’t stop there. If the drug eventually is approved by the Food and Drug Administration (FDA), the expected lower retail cost of GR-MD-02 could save patients thousands of dollars every year. Current medications on the
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market (both shots and pills) can run patients $30,000 to $40,000 a year, Ritchie estimates. “The cost is massive,” he says. “And sometimes those drugs aren’t very effective.” Even with all the positive results from the study so far, Ritchie is hesitant to get psoriasis and eczema patients’ hopes up. “It all has to play out in the research,” he says. “We won’t know until we know.”
Eczema Trial
Because of GR-MD-02’s effectiveness with psoriasis, Simon and his fellow dermatologist Casey Bowen are now conducting a six-month, “compassionate use” study on the drug’s ability to counteract severe adult atopic dermatitis, a.k.a. eczema. “I have kind of become our department guru on atopic dermatitis over the last few years,” Bowen reports. “I’ve been lecturing on the topic for four years now.” The FDA allows “compassionate use” studies for drugs that show promise in treating conditions or diseases for which there currently are no effective treatment options.
Maj. Casey Bowen ‘04 (left) and Maj. Simon Ritchie ‘03 examine a slide while doing research on a new drug aimed at skin diseases. (Photos by SSgt Kevin Iinuma.)
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Bowen recruited three patients who suffer from severe cases of eczema. The first patient has already finished six months of infusions but, because of the positive results, that patient’s involvement in the study has been extended for six more months. The other two patients are nearing the end of their infusion schedule. According to the Galectin Therapeutics website, the new drug has shown promise among eczema patients as well, although the final report has yet to be compiled. Early indications are that GR-MD-02 may be even more effective against eczema — which affects between 10 and 15 percent of the nation’s population — than with psoriasis, Bowen suggests. Incidents of severe adult atopic dermatitis are much more rare, however. Bowen expects to complete his study in the weeks ahead and compile his final report on the drug’s effectiveness against eczema. Whatever the final outcome, Bowen says he’s enjoyed being part of the research. “It is cool to be involved in the cutting edge of dermatology and try to make a name for our program,” Bowen says.
Next Steps
Ritchie recently presented the results of his research at a dermatology conference and he’s hoping to publish a paper on the subject in the next month or two. Next, Ritchie and Bowen hope to launch the next phase of FDA trials on psoriasis and eczema. The next phase of the research will require medical researchers to sign up 200 to 250 patients willing to take the new drug. Each patient will receive different dosages of the medication and the results will be tabulated. “We’re basically looking to see how each one responds and if there are any safety events,” Ritchie explains. Eventually, the drug will go through double-blind studies where both the patients and doctors don’t know who is receiving the drug and who is receiving a placebo during the course of the infusions. If the patients who are given the actual drug show significantly more improvement than the placebo group, the FDA will likely approve the treatment for use.
“Hundreds of patients have received this drug and not a single person has had an adverse event ... That’s very, very significant.” “We’re not sure yet if we’re going to do the next step study with psoriasis patients or if we’re going to do it with eczema patients,” Ritchie reports. “That hasn’t been determined.”
Military Partnerships
It’s somewhat unusual for Air Force physicians to participate in clinical trials for drugs being developed by civilian companies, but it’s not unheard of, according to Ritchie. Part of the challenge is the initial set-up of the project. “It took about a year to go through the whole process, and that’s with being very proactive and working very, very diligently,” Ritchie notes. “It still takes a long time to get studies approved.” Military members have to gain approval for proposed research projects through their institutional review boards, and then the entire process is tightly monitored to ensure the safety of patients and to eliminate any potential conflicts of interest with the military personnel involved. “It all has to be above board, obviously,” Ritchie explains. “I don’t get paid by the pharmaceutical company — no military physician gets paid by a pharmaceutical company. We just do Checkpoints · June 2017 · 61
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Maj. Simon Ritchie ‘03 examines a patient at his clinic. (Photos by SSgt Kevin Iinuma.) this because we’re interested in furthering the science and getting better care for our patients.” Bowen adds that Air Force doctors have another stumbling block when it comes to conducting research. Because they move to a new location every three or four years, military physicians have a hard time committing to long-term projects. “It’s a tough thing to do clinical research as an active duty physician,” he admits. “That’s why not a whole lot of it is done. Just to start clinical research is kind of a daunting task. When you’re only at a base for three or four years, it’s hard to get something off the ground and running.” Bowen is PCSing in July and Ritchie is moving to his next assignment in September. Both dermatologists hope to be involved in the next phase of GR-MD-02 research at their next locations, but they can’t be certain. “I’m hoping to be involved in the actual studies themselves, but that will be left up to my next base that I’m PCSing to,” Ritchie says. “I’m hoping to enroll patients locally and continue with the treatments. But, at a minimum, I’m going to be an advisor to the company — unpaid.”
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