Nuvo Research (TSX:NRI) plans to release, in the first quarter of 2015, the results of a confirmatory Phase 2 study for a potential blockbuster allergic rhinitis drug, WF10, which could be a game-changing treatment for moderate-to-severe allergies.
“We are targeting a large unmet medical need among some 10 million people in the U.S. who get only limited relief from conventional products and are eligible for allergy shots,” John London, president and co-CEO, says in an interview with BioTuesdays.com.
“Drugs in the over-the-counter and prescription markets are mostly old and mainly treat symptoms, without treating the underlying cause or providing long-term relief,” he adds.
Nuvo is best known for developing Pennsaid and its follow-on, Pennsaid 2%, two topical treatments for osteoarthritis of the knee. Pennsaid is sold in the U.S., Canada, Italy and Greece. Pennsaid 2% is currently sold only in the U.S., having been approved by the FDA earlier this year.
The company has developed three other topical products: Pliaglis, a local analgesia used prior to dermatological treatments and cosmetic surgery, and sold globally by Galderma; HLT Patch, a local analgesia used prior to painful needle injections, mainly in children, which has been licensed for the U.S. to Galen and for Europe to Eurocept; and Oxoferin, a treatment for chronic wounds, which is sold in parts of Europe, Asia and South America by several marketing partners, including Ranbaxy.
“We know how to get products approved, and we know how to partner,” Mr. London says. “At this point, we consider ourselves to be something of a hybrid company in that we have approved products generating revenue like a specialty pharma company while, as a biotech company, we have a highly promising development stage asset in WF10.”
In an earlier Phase 2 trial at one clinical site in Germany, with 60 refractory patients sensitive to multiple allergens, WF10 posted statistically significant results as measured by total nasal symptom score (TNSS) and other secondary endpoints, compared with a placebo.
“We did a follow-up after one year and found that the WF10 patients were still virtually symptom-free,” Mr. London contends. “Key opinion leaders were very excited when we showed them evidence of WF10’s superior efficacy, compared with other treatments.”
According to Nuvo chairman and co-CEO, Dan Chicoine, WF10 has significant advantages, compared with existing immunotherapies like allergy shots, for severe allergy sufferers.
He points out that WF10 covers a broad range of allergens, with duration of effect of 18 months to two years, while allergy shots are allergen-specific and require multiple needles for each allergy over many years. WF10 is administered intravenously for 60-to-90 minutes over five consecutive treatment days.
“We have a favorable safety profile, while the side effects of immunotherapy include possible anaphylactic shock from injections,” he adds. “That’s why patients need to wait in a doctor’s office for 15 or 30 minutes after their allergy shots.”
Mr. Chicoine says that in the earlier Phase 2 study, WF10 demonstrated a significant clinical benefit, with a reduction in nasal symptoms of over 70%. On the other hand, many immunotherapy patients discontinue treatment because of a moderate clinical benefit and the inconvenience of multiple series of allergy shots over several years.
A recent survey by Psscion Consulting of patients, allergists and insurers forecast that WF10 would capture 10% to 15% of the U.S. refractory allergic rhinitis market, with peak U.S. annual sales of $700-million to $1.1-billion.
In the course of the survey, Psscion found that physicians were impressed with WF10’s efficacy, long-lasting therapeutic effect, its ability to treat multiple allergens with one dosing regimen and its favorable safety profile.
Patients and physicians suggested that WF10 could be an attractive alternative to allergy shots, which are highly specific to one particular allergen and must be dosed for months or years. Insurance payers also rated WF10 positively and observed that it would be unlikely to face significant barriers to coverage.
Nuvo recently dosed the final patient in its confirmatory Phase 2 trial at 15 clinical sites in Germany. The company had aimed for 160 patients, but Mr. London says the study was overenrolled with 183 patients.
In addition to a WF10 arm and placebo arm, the company has two other WF10 treatment arms, in which certain constituent elements of WF10 have been removed. This should shed additional light on the active ingredient in WF10 that is contributing most to its therapeutic benefit.
The study is measuring TNSS and secondary endpoints at weeks 3, 6, 9, 12 and 16. Patients will be followed up at months six, 12, 18 and 24 to confirm the long-term benefits of WF10.
If the study is successful, Nuvo plans to seek a meeting with the FDA next year as a stepping-stone to start a Phase 3 clinical trial of WF10 in 2016 in the U.S. and Europe. Mr. London says the studies may differ slightly because of different allergens common to both areas.
Nuvo also plans to conduct a dosing study in 2015 to determine whether fewer than five days of infusion with WF10 can be effective. It also plans more animal studies to better understand WF10’s mechanism of action at the cellular level.
Nuvo is currently sitting on a pile of cash. In September, the company settled its litigation against former U.S. marketing partner, Mallinckrodt, regaining the U.S. rights to Pennsaid and Pennsaid 2% and receiving a payment of $10-million. A month later, it resold the Pennsaid 2% U.S. marketing rights to Horizon Pharma (NASDAQ:HZNP) for $45-million.
Earlier this month, Nuvo reacquired the Pennsaid 2% marketing rights in South America, Central America, South Africa and Israel. It now owns all rights to Pennsaid 2% outside of the U.S., with the exception of Canada, Russia and Greece where it already has marketing partnerships in place.
In the second quarter next year, Nuvo plans to begin a Phase 3 trial in Germany, with data expected at the end of 2015. The study will assess the efficacy of Pennsaid 2% for the relief of pain associated with acute, localized muscle or joint injuries such as sprains, strains or sports injuries.
According to Mr. Chicoine, the Phase 3 study will support regulatory approval in many jurisdictions, including Europe and is an “integral part of our plan to seek a partner or partners to market Pennsaid 2% internationally and make Pennsaid 2% a global brand.”