WAKEFIELD, MA /ACCESSWIRE/July 22, 2022/ Innovation Pharmaceuticals (OTCQB: IPIX) (“the Company”), a clinical-stage biopharmaceutical company, today provided an update on the Company’s Brilacidin program in oral mucositis (OM). Brilacidine, administered as a mouthwash, has been shown in phase 2 clinical trials (NCT02324335) to reduce the incidence, delay the onset and decrease the duration of severe OM (WHO grade ≥ 3) in patients with head and neck cancer (HNC) receiving chemoradiotherapy. The company and the FDA have completed an end of phase 2 meeting and agreed on an acceptable phase 3 program.
To assess current insurance programs and the overall commercialization potential of Brilacidin in OM, the company engaged separate consulting firms to analyze the provider and payer landscape – in particular, the likelihood that clinicians prescribe and insurers reimburse a new OM treatment, such as Brilacidin, should it eventually gain marketing approval. The results of this analysis are summarized below.
- Great unmet need: Oral mucositis (OM) poses a significant socioeconomic cost to the healthcare system and to patients, as it can have a significant impact on quality of life, lead to hospitalization, and lead to disruption of cancer treatment and less good results. Current standard of care (SOC) treatment options (primarily devices) are lacking as they only act as symptom management and do not decrease the incidence of severe OM (SOM).
- Competitive positioning: The oral sachet formulation of Brilacidin was perceived as convenient and highly preferred by key opinion leaders (KOLs) over intravenous (IV) options, and KOLs are willing to prescribe Brilacidin to all HNC patients because preventive properties of the compound and its ease of use as a mouthwash. Brilacidin has the potential to be a first-line product for the prevention and treatment of SOM due to its perceived clinically significant efficacy.
- Development Considerations: KOLs considered the primary endpoint of reduced incidence of MOS favorable, but recommend additional secondary endpoints to promote greater uptake (i.e. maximizing overall efficacy (reduction of MOS) has been identified as a higher KOL priority than the specific mechanism of action (anti-inflammatory activity) through which efficacy is achieved.
- Coverage outlook: The development of Brilacidin as a New Drug Application (NDA), via the 505(b)(1) pathway, significantly improves the commercialization prospects of Brilacidin in the OM therapeutic area. OM products, such as MuGard, GelClair, Episil and Caphosol, which were developed as devices and not as drugs, have struggled to show clinical benefit, as they are primarily palliative in nature and, from the from the perspective of the government payer, are not covered by Medicare Part RE.
- Refund Landscape: At least 2 approved drugs in all therapeutic drug classes must be made available under Medicare Part D, according to USP Medicare model guidelines. The guidelines establish the framework (rules) that govern payer forms. Since there are no approved drugs for OM in HNC, if Brilacidin were approved, it is highly likely that it would be included in payer formularies as a pharmaceutical benefit.
- business opportunity: Annually, in the United States, Brilacidin has the potential to treat 52,000 OM patients in HNC, with a potential future expansion to 20,000 OM patients in hematopoietic stem cell transplant (HSCT) and 160,000 OM patients in all categories of chemotherapy. Based on physician estimates of Brilacidin uptake and other price-based assumptions, the annual US sales forecast is $188 million for OM in HNC patients in 2030, with a potential additional increase of $106 million for OM in HSCT and $598 million for OM in all chemotherapy categories.
“This analysis reinforces Brilacidin’s potential to become a breakthrough treatment for OM and a commercial success,” said Leo Ehrlich, CEO of Innovation Pharmaceuticals. “While we have focused on Brilacidin for the past several years in the antiviral space, in light of COVID-19, we have made significant progress in advancing Brilacidin in OM, including refining the formulation of the mouthwash in sachet form. We continue to seek partnership opportunities so that Brilacidin can be even more advanced in oral mucositis in the clinic.”
Additional information about Brilacidin-OM’s revenue opportunity based on this analysis is available on the Company’s website at the link below:
About oral mucositis
Oral mucositis (OM) is a painful and debilitating complication of chemoradiotherapy.1 Head and neck cancer (HNC) patients, including approximately 66,000 newly diagnosed cases in the United States in 20212and about 900,000 worldwide3, are at high risk of developing OM. By 2030, the global incidence of HNC cases is expected to exceed 1 million per year. Additionally, between 25 and 60 percent of cancer patients, regardless of cancer type, will also experience OM. Characterized by inflammation and ulceration, patients with OM are often unable to speak and eat (requiring insertion of a feeding tube) and are more susceptible to infections, with severe cases resulting in hospitalization at increased treatment costs of up to $25,000. There are currently no approved drugs for the prevention of OM in the HNC population, with only limited palliative care options available. Worldwide, the OM market was estimated at $1.5 billion in 2021.4
1 Expanding the scope of oral mucositis and oral ulcerative mucosal toxicities of cancer therapies – Elad – 2022 – CA: A Cancer Journal for Clinicians – Wiley Online Library
2 Cancer Statistics, 2021 – PubMed (nih.gov)
3 World Cancer Observatory (iarc.fr)
4 Oral Mucositis Market Size, Epidemiology, Market Research 2032 (delveinsight.com)
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About Innovation Pharmaceuticals
Innovation Pharmaceuticals Inc. (IPIX) is a clinical-stage biopharmaceutical company developing a portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer and infectious diseases. The Company is also active in evaluating other potential investment opportunities that can add value and diversify its portfolio.
Forward-looking statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding future product development plans, including with respect to relating to specific indications; statements regarding the therapeutic potential and capabilities of the StingRay System; future regulatory developments; and any other statements other than statements of historical fact. These statements involve risks, uncertainties and assumptions that could cause actual results and experience to differ materially from the anticipated results and expectations expressed in these forward-looking statements. In some cases, the Company has identified forward-looking statements by using words such as “anticipates”, “believes”, “hopes”, “estimates”, “looks”, “expects”, “plans”, “intends “, ” objective “. ,” “potential”, “may”, “suggest” and similar expressions. Other factors that could cause actual results to differ materially from those expressed in the forward-looking statements include risks relating to the realization of preclinical studies and clinical trials and seeking regulatory and licensing approvals in the United States and other jurisdictions, including, without limitation, which aggravate and the devices may not pass the preclinical or clinical testing, or obtain regulatory approval to be sold and marketed in the United States or elsewhere; results of prior testing may not be replicated in future studies and trials; company need and availability of capital substantial amounts in the future to fund its operations and research and development, including the amount and timing of the sale of common stock under securities purchase agreements; and the (s) licensee(s) of the Company may not pass preclinical or clinical testing and the Company will not receive milestone payments. A more complete description of these and other risk factors is included in the Company’s filings with the Securities and Exchange Commission. Many of these risks, uncertainties and assumptions are beyond the Company’s ability to control or predict. You should not place undue reliance on forward-looking statements. Forward-looking statements apply only to information currently available to the Company as of the date they are made, and the Company undertakes no obligation to publicly release the results of any revisions to such forward-looking statements that may be made for to reflect events or circumstances after the date of this press release or to reflect the occurrence of unforeseen events, except as required by applicable law or regulation.
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