Our Disease Target: Chronic Rhinosinusitis
What is Chronic Rhinosinusitis?
Chronic rhinosinusitis (CRS) represents inflammation of the nose and sinuses lasting 3 months or more and which does not result from ongoing infection. It affects individuals of all races and ethnicities and is a global disease. Although other symptoms may be present¹, its medical diagnosis is based on four cardinal symptoms:
• Nasal/sinus congestion
• Postnasal drip
• Loss of sense of smell
• Facial pain/pressure
Effects of CRS on Patients
The effects of CRS produce significant pain and suffering for patients including:
• Chronic headaches²
• Sleep problems/severe fatigue³
• Depression rates 2-4x the general population³
• Reduced cognitive function³
• Diminished productivity at work and home⁴
In fact, CRS patients have a reduced Quality of Life – lower than patients with congestive heart failure, chronic obstructive pulmonary disease, angina, back pain/sciatica⁵, and comparable to asthma and early Parkinson’s Disease⁶.
Many People Have CRS But Most Are Untreated. Many Who Are Treated Fail Current Therapy.
Research analysts indicate CRS affects ~30M adults in the US (20M without nasal polyps and 10M with nasal polyps). Further, CRS represents one of the most common diagnoses in adult outpatient medicine annually at 10M⁷. The prevalence is similar in Europe. Yet patient data indicates only about 17% of individuals with CRS have a formal diagnosis for the disease, suggesting a large unmet medical need. For those that seek treatment, current treatment modalities are often inadequate.
Current Treatments and Limitations
Antibiotics are used for acute and chronic bacterial infections of the sinonasal system but fail to address the chronic inflammation associated with CRS and may lead to significant side effects such as antibiotic resistance, allergic reactions, and disruption of the healthy microbiome of the nose and body.
One effective treatment for CRS is sinonasal irrigation with saline. This irrigation involves flushing the sinonasal cavity with a high volume (120-240ml) of saline similar to using a neti pot. However, this treatment does not address the underlying inflammation caused by CRS.
Nasal corticosteroid sprays have an anti-inflammatory action but achieve coverage only in the front part of the nose and fail to distribute widely into the back of the nose and sinuses where CRS related inflammation and any associated nasal polyps occur. For this reason, one of the most common treatments of CRS is the addition of corticosteroids to nasal saline irrigations in an off-label fashion to achieve improved sinonasal distribution and therapeutic efficacy. In fact corticosteroid off-label nasal corticosteroid irrigations are currently considered one of the gold standard in the treatments for CRS⁸ .
Corticosteroid eluting implants are costly, require a procedure for placement, can be associated with crusting, and may need to be actively removed if they do not fully dissolve
Surgery is effective in many patients but is restricted to patients with medically refractory disease and does not permanently address the long-term chronic inflammation associated with CRS. Furthermore, most patients with inflammatory CRS still require ongoing topical or systemic anti-inflammatory therapies even after surgery.
Biologic drug therapies such as monoclonal antibodies are extremely expensive, require injections, and chronic use. They may be associated with both local and systemic side effects.
In contrast to the treatments described above, Diceros’ lead product (Verasone) has a novel, evidence-based dual-action anti-inflammatory mechanism and will be dosed by sinonasal irrigation, the most direct and effective way to deliver drugs to treat CRS.
CRS is a Main Driver of Needless Use of Antibiotics.
Among all primary care visits where an antibiotic is prescribed, the diagnosis of CRS accounts for the most common indication at 7.1%. Thus, inappropriate CRS treatment is a major contributor to antibiotic resistance⁹.
Bibliography
¹ See, e.g. Mayo Clinic site.
² D. Hamilos, et al., Clin Allergy Immunol, 2007
³ R. Orlandi, et al., International Consensus Statement on Rhinosinusitis, 2021
⁴ L. Rudmik et al., Laryngoscope, 2014
⁵ R. Glikich and R. Metson, Otolarygology – Head and Neck Surg, 1995
⁶ Z. Soler, et al., Laryngoscope, 2011
⁷ Jefferies equity research, March 18, 2020 Q. Husain et al., Int Forum Allergy Rhinol, 2020⁹ Smith SS, et al. J Allergy Clin Immun, 2013
⁸ Q. Husain et al., Int Forum Allergy Rhinol, 2020
⁹ Smith SS, et al. J Allergy Clin Immun, 2013