Home Cellular health Gilead Sciences to Release Second Quarter 2022 Financial Results on Tuesday, August 2, 2022

Gilead Sciences to Release Second Quarter 2022 Financial Results on Tuesday, August 2, 2022


– First patient scheduled for enrollment in the fourth quarter of 2022; First CALM-1 results expected in 2H 2024 –

BELLUS Health Inc. (Nasdaq: BLU; TSX: BLU) (“BELLUS Health” or the “Company”), a clinical-stage biopharmaceutical company developing novel therapies for the treatment of chronic intractable cough and other indications of cough hypersensitivity , today announced a positive End of Phase 2 (“EOP2”) meeting with the U.S. Food and Drug Administration (“FDA”) and details of the Phase 3 CALM program for BLU-5937, a A second-generation highly selective P2X3 antagonist product candidate for the treatment of refractory chronic cough (“RCC”).

“The successful conclusion of our end of phase 2 meeting with the FDA marks an important milestone for BELLUS. We appreciate the support and guidance of the FDA and are pleased to have identified a clear regulatory path to eventual approval of BLU-5937. commented Roberto Bellini, President and CEO of BELLUS Health. “Based on our SOOTHE Phase 2b data, we remain confident in the potential of BLU-5937 to be the best-in-class treatment option for RCC patients, if approved. We are well positioned to execute our CALM Phase 3 program, with sufficient financial resources to bring us the best results with CALM-1, and we look forward to launching this pivotal program in the fourth quarter.”

Based on FDA feedback, the CALM Phase 3 program is comprised of two pivotal trials, CALM-1 and CALM-2, each evaluating the efficacy, safety, and tolerability of BLU-5937 in approximately 675 adults with of RCC. CALM-1 and CALM-2 will be placebo-controlled, randomized 1:1:1 parallel arm trials with expected treatment arms of 25 mg BID, 50 mg BID and placebo. The primary endpoint of 24-hour cough frequency will be measured at 12 weeks for CALM-1 and 24 weeks for CALM-2. The company has aligned with the FDA so that the primary endpoint of the Phase 3 CALM program, similar to the successful Phase 2b trial SOOTHE, can be assessed using the VitaloJAK cough monitoring system in a patient population enriched for a baseline 24-hour cough rate of ≥ 20 coughs/hour (equivalent to awake cough rate ≥ 25 coughs/hour used in the phase 2b SOOTHE trial). Key secondary efficacy endpoints include cough severity using the Visual Analogue Scale (“CS-VAS”), Leicester Cough Questionnaire (“LCQ”), and chronic cough diary ( “CCD”). CALM Phase 3 trials will also enroll participants with baseline 24-hour cough frequency

About the BLU-5937

BLU-5937, a highly selective P2X3 antagonist, is being developed for RCC and other indications of cough hypersensitivity.

The P2X3 receptor, which is involved in cough reflex hypersensitization, is a rational target for the treatment of chronic cough, and it has been evaluated in multiple clinical trials with different P2X3 antagonists. The Company believes that its highly selective antagonist P2X3 has the potential to reduce cough frequency in patients with RCC and improve quality of life while limiting adverse events related to taste disorders.

In addition to RCC, the mechanism of action of BLU-5937 may also have broad therapeutic applicability in other indications of cough hypersensitivity. The Company is evaluating potential opportunities to study BLU-5937 in other cough indications where cough hypersensitivity plays an important role.

About BELLUS Health ( www.bellushealth.com )

BELLUS Health is a clinical-stage biopharmaceutical company developing novel therapies for the treatment of RCC and other indications of cough hypersensitivity. The Company’s product candidate, BLU-5937, has successfully completed a Phase 2b trial in RCC. BELLUS Health is planning a Phase 3 program, with enrollment expected to begin in the fourth quarter of 2022.

Chronic cough is a cough that lasts more than eight weeks. When the cause of chronic cough cannot be identified or the cough persists despite treatment of all identified associated causes, the condition is called RCC. It is estimated that there are approximately 9 million patients in the United States with RCC. CRC is associated with significant negative physical, social and psychological effects on health and quality of life. Currently, there are no specific approved therapies for RCC and treatment options are limited.

The Company is exploring the potential use of BLU-5937 in other patient populations with cough hypersensitivity as well as other P2X3-related hypersensitivity states.

Forward-looking statements

Certain statements contained in this press release, other than statements of fact that are independently verifiable as of the date hereof, may constitute “forward-looking statements” within the meaning of Canadian securities laws and regulations, the US Private Securities Litigation Reform Act of 1995, as amended, and other applicable securities laws. Forward-looking statements are frequently, but not always, identified by words such as “expects”, “anticipates”, “believes”, “intends”, “estimates”, “potential”, “possible”. , “projects”, “plans”, and similar expressions. Such statements, based on the current expectations of management, inherently involve numerous important risks, uncertainties and assumptions, known and unknown, many of which are beyond the control of BELLUS. These statements include, but are not limited to, the potential for BLU-5937 to successfully treat RCC and other hypersensitivity-related disorders and to benefit these patients, BELLUS Health’s expectations regarding its studies preclinical and its clinical trials, including timing of initiation and design of its Phase 3 clinical trials of BLU-5937 in RCC, timing and results of interactions with regulatory agencies, potential activity and the profile of tolerability, selectivity, potency, and other characteristics of BLU-5937, including relative to other competing candidates, particularly where direct studies have not been conducted and comparisons between trials may not be directly comparable due to differences in study protocols, conditions and patient populations, the market potential of BLU-5937, including with respect to patient population, pricing and labeling, location BELLUS Health’s financial and sufficiency of cash resources to achieve the best results with CALM-1, and the potential applicability of BLU-5937 and BELLUS Health’s P2X3 platform to treat other disorders. Risk factors that could affect BELLUS Health’s future results include, but are not limited to: the benefits and on-label impact of its fortification strategy, estimates and projections regarding the size and opportunities of the RCC’s addressable market for BLU-5937, the ability to expand and develop its pipeline of projects, the ability to obtain adequate financing, the ability of BELLUS Health to maintain its intellectual property rights and obtain adequate protection future products using this intellectual property, the impact of general economic conditions, general conditions in the pharmaceutical industry, the impact of the ongoing COVID-19 pandemic on BELLUS Health’s operations, plans and outlook , including the initiation and completion of clinical trials in a timely manner or not at all, changes in the regulatory environment in jurisdictions where BELLUS Health operates its operations, supply chain impacts, stock market volatility, cost fluctuations, changes in the competitive environment due to consolidation, achievement of planned burn rate, achievement of planned milestones of preclinical studies and clinical trials, reliance on third parties to conduct preclinical studies and clinical trials for BLU-5937 and that actual results may differ from primary results once finalized and quality-controlled data verification and analysis is complete. Additionally, the duration of the development process for BELLUS Health’s product candidate along with its market size and commercial value depends on a number of factors. In addition, BELLUS Health’s growth and future prospects are primarily dependent on the successful development, patient safety, regulatory approval, commercialization and market acceptance of its product candidate BLU- 5937 and other products. Therefore, actual future results and events may differ materially from the anticipated results and events expressed in the forward-looking statements. BELLUS Health believes that the expectations represented by the forward-looking statements are reasonable, but there can be no assurance that such expectations will prove to be correct. The reader should not place undue reliance, if any, on the forward-looking statements included in this press release. These forward-looking statements speak only as of the date they are made, and BELLUS Health is under no obligation and disclaims any intention to publicly update or revise these statements as a result of any new information, future events , circumstances or otherwise, unless required by the applicable provisions. laws or regulations. Please see public documents filed by BELLUS Health with Canadian securities regulators, including, but not limited to, its Annual Information Form, and with the United States Securities and Exchange Commission, including, but not limited to limit, its annual report on Form 40-F, for other risk factors that could affect BELLUS Health and its activities.

Ramzi Benamar
Financial director
[email protected]

Julia Deutsch
Solebury Trout
[email protected]
Source: BELLUS Health Inc.