UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

For the month of July 2022

 

Commission File Number: 001-39034

 

BELLUS HEALTH INC.

(Name of registrant)

 

275 Armand-Frappier Blvd.

Laval, Québec

H7V 4A7

Canada

(Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

  ¨ Form 20-F x Form 40-F  

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ¨

 

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  BELLUS Health Inc.    
   
Date: July 12, 2022 By: /s/ Ramzi Benamar
    Name: Ramzi Benamar
Title: Chief Financial Officer

 

 

 

 

Form 6-K Exhibit Index

 

Exhibit
Number
  Document Description
99.1   News Release dated July 12, 2022. BELLUS Health Announces Positive End-of-Phase 2 Meeting with the FDA and its CALM Phase 3 Program for BLU-5937 in Refractory Chronic Cough.
99.2   Presentation dated July 12, 2022.

 

 

 

 

Exhibit 99.1

 

Bellus Health Announces Positive End-of-Phase 2 Meeting with the FDA and its CALM Phase 3 Program for BLU-5937 in Refractory Chronic Cough

 

- CALM Phase 3 program consists of two pivotal trials (CALM-1 and CALM-2), with primary efficacy endpoint of 24-hour cough frequency measured at 12- and 24-weeks, respectively -

 

- The Company has reached alignment with FDA on the primary efficacy endpoint of 24H cough frequency reduction being assessed using the VitaloJAK cough monitoring system in a patient population enriched for baseline cough frequency -

 

- First patient expected to be enrolled in the fourth quarter of 2022; Topline results from CALM-1 expected in 2H 2024 -

 

LAVAL, Quebec--July 12, 2022-- BELLUS Health Inc. (Nasdaq: BLU; TSX: BLU) (“BELLUS Health” or the “Company”), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of refractory chronic cough and other cough hypersensitivity indications, today announced a positive End-of-Phase 2 (“EOP2”) meeting with the U.S. Food and Drug Administration (“FDA”) and the details of the CALM Phase 3 program for BLU-5937, a highly selective, second generation P2X3 antagonist product candidate, for the treatment of refractory chronic cough (“RCC”).

 

“The successful completion of our End-of-Phase 2 meeting with the FDA marks a significant milestone for BELLUS. We are appreciative of the FDA’s support and guidance and are pleased to have identified a clear regulatory path to a potential approval for BLU-5937,” commented Roberto Bellini, President and Chief Executive Officer of BELLUS Health. “Based on our SOOTHE Phase 2b data, we remain confident in BLU-5937’s potential to be a best-in-class treatment option for RCC patients, if approved. We are well positioned to execute our CALM Phase 3 program, with cash resources sufficient to bring us through topline results with CALM-1, and we look forward to initiating this pivotal program in the fourth quarter.”

 

Based on the FDA's feedback, the CALM Phase 3 program is composed of two pivotal trials, CALM-1 and CALM-2, each evaluating the efficacy, safety and tolerability of BLU-5937 in approximately 675 adults with RCC. CALM-1 and CALM-2 will be placebo-controlled, parallel-arm trials randomized 1:1:1 with expected treatment arms of 25 mg BID, 50 mg BID and placebo. The primary endpoint of 24H cough frequency will be measured at 12-weeks for CALM-1 and 24-weeks for CALM-2. The Company has reached alignment with the FDA that the CALM Phase 3 program’s primary endpoint, similar to the successful SOOTHE Phase 2b trial, can be assessed using the VitaloJAK cough monitoring system in a patient population enriched for baseline 24H cough frequency of ≥20 coughs/hour (equivalent to awake cough frequency of ≥25 coughs/hour used in SOOTHE Phase 2b trial). Key secondary efficacy endpoints include Cough Severity using Visual Analogue Scale (“CS-VAS”), the Leicester Cough Questionnaire (“LCQ”) and Chronic Cough Diary (“CCD”). The CALM Phase 3 trials will also enroll participants with baseline 24H cough frequency <20 coughs/hour. A key secondary efficacy endpoint will assess reduction in cough frequency in a broader population including the enriched population and additional participants with baseline 24H cough frequency below 20 coughs/hour. CALM-1 will have a 40-week randomized extension period and an additional 24-week open label extension. CALM-2 will have a 28-week open label extension. The trials are planned to run in parallel, and the Phase 3 CALM program is expected to enroll its first patient in the fourth quarter of 2022. Topline data from CALM-1 are expected in the second half of 2024.

 

 

 

 

About BLU-5937

 

BLU-5937, a highly selective P2X3 antagonist, is in development for RCC and other cough hypersensitivity indications.

 

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

 

In addition to RCC, the mechanism of action of BLU-5937 may also have broad therapeutic applicability across other cough hypersensitivity indications. The Company is evaluating potential opportunities to study BLU-5937 in additional 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 therapeutics for the treatment of RCC and other cough hypersensitivity indications. The Company's product candidate, BLU-5937, has successfully completed a Phase 2b trial in RCC. BELLUS Health is planning a Phase 3 program, which is expected to begin enrollment in the fourth quarter of 2022.

 

Chronic cough is a cough lasting longer 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 referred to as RCC. It is estimated that there are approximately 9 million patients in the United States suffering from RCC. RCC is associated with significant adverse physical, social, and psychological effects on health and quality of life. Currently, there is no specific therapy approved for RCC and treatment options are limited.

 

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

 

 

 

 

Forward-Looking Statements

 

Certain statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, may constitute "forward-looking statements" within the meaning of Canadian securities legislation and regulations, the U.S. 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 as they are on the current expectations of management, inherently involve numerous important risks, uncertainties and assumptions, known and unknown, many of which are beyond BELLUS Health's control. Such statements include, but are not limited to, the potential of BLU-5937 to successfully treat RCC and other hypersensitization-related disorders and benefit such patients, BELLUS Health’s expectations related to its preclinical studies and clinical trials, including the timing of initiation of and the design of its Phase 3 clinical trials of BLU-5937 in RCC, the timing and outcome of interactions with regulatory agencies, the potential activity and tolerability profile, selectivity, potency and other characteristics of BLU-5937, including as compared to other competitor candidates, especially where head-to-head studies have not been conducted and cross-trial comparisons may not be directly comparable due to differences in study protocols, conditions and patient populations, the commercial potential of BLU-5937, including with respect to patient population, pricing and labeling, BELLUS Health’s financial position and sufficiency of cash resources to bring through topline results with CALM-1, and the potential applicability of BLU-5937 and BELLUS Health’s P2X3 platform to treat other disorders. Risk factors that may affect BELLUS Health’s future results include but are not limited to: the benefits and impact on label of its enrichment strategy, estimates and projections regarding the size and opportunity of the addressable RCC market for BLU-5937, the ability to expand and develop its project pipeline, the ability to obtain adequate financing, the ability of BELLUS Health to maintain its rights to intellectual property and obtain adequate protection of future products through such 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 prospects, including to the initiation and completion of clinical trials in a timely manner or at all, changes in the regulatory environment in the jurisdictions in which BELLUS Health does business, supply chain impacts, stock market volatility, fluctuations in costs, changes to the competitive environment due to consolidation, achievement of forecasted burn rate, achievement of forecasted preclinical study and clinical trial milestones, reliance on third parties to conduct preclinical studies and clinical trials for BLU-5937 and that actual results may differ from topline results once the final and quality-controlled verification of data and analyses has been completed. In addition, the length of BELLUS Health’s product candidate’s development process and its market size and commercial value are dependent upon a number of factors. Moreover, BELLUS Health’s growth and future prospects are mainly dependent on the successful development, patient tolerability, regulatory approval, commercialization and market acceptance of its product candidate BLU-5937 and other products. Consequently, actual future results and events may differ materially from the anticipated results and events expressed in the forward-looking statements. BELLUS Health believes that expectations represented by forward-looking statements are reasonable, yet there can be no assurance that such expectations will prove to be correct. The reader should not place undue reliance, if any, on any forward-looking statements included in this news release. These forward-looking statements speak only as of the date made, and BELLUS Health is under no obligation and disavows any intention to update publicly or revise such statements as a result of any new information, future event, circumstances or otherwise, unless required by applicable legislation or regulation. Please see BELLUS Health's public filings with the Canadian securities regulatory authorities, including, but not limited to, its Annual Information Form, and the United States Securities and Exchange Commission, including, but not limited to, its Annual Report on Form 40-F, for further risk factors that might affect BELLUS Health and its business.

 

FOR MORE INFORMATION, PLEASE CONTACT:

Ramzi Benamar

Chief Financial Officer

rbenamar@bellushealth.com

 

Media:

Julia Deutsch

Solebury Trout

jdeutsch@soleburytrout.com

 

 

Source: BELLUS Health Inc.

 

 

 

 

Exhibit 99.2

 

BLU - 5937 for Refractory Chronic Cough: Positive FDA End of Phase 2 Meeting and its CALM Phase 3 Program Design JULY 12, 2022

 

 

Forward Looking Statements 1 Certain statements contained in this presentation, other than statements of fact that are independently verifiable at the dat e h ereof, may constitute "forward - looking statements" within the meaning of Canadian securities legislation and regulations, the U.S. Private Securities Litigation Reform Act of 1995, as ame nde d, and other applicable securities laws. Forward - looking statements are frequently, but not always, identified by words such as “expects,” “anticipates,” “believes,” “intends,” “esti mat es,” “potential,” “possible,” “projects,” “plans,” and similar expressions. Such statements, based as they are on the current expectations of management, inherently involve numerous import ant risks, uncertainties and assumptions, known and unknown, many of which are beyond BELLUS Health Inc.'s (“BELLUS Health”) control. Such statements include, but are not limite d t o, the potential of BLU - 5937 to successfully treat refractory chronic cough (“RCC”) and other hypersensitization - related disorders and benefit such patients, BELLUS Health's expec tations related to its preclinical studies and clinical trials, including the timing of initiation of and the design of its Phase 3 clinical trials of BLU - 5937 in RCC, the timing and o utcome of interactions with regulatory agencies, the potential activity and tolerability profile, selectivity, potency and other characteristics of BLU - 5937, including as compared to other co mpetitor candidates, especially where head - to - head studies have not been conducted and cross - trial comparisons may not be directly comparable due to differences in study protocols, condit ions and patient populations, the commercial potential of BLU - 5937, including with respect to patient population, pricing and labeling, BELLUS Health's financial position and sufficie ncy of cash resources to bring through topline results with CALM - 1, and the potential applicability of BLU - 5937 and BELLUS Health's P2X3 platform to treat other disorders. Risk factors tha t may affect BELLUS Health's future results include but are not limited to: the benefits and impact on label of its enrichment strategy, estimates and projections regarding the size an d opportunity of the addressable RCC market for BLU - 5937, the ability to expand and develop its project pipeline, the ability to obtain adequate financing, the ability of BELLUS Healt h t o maintain its rights to intellectual property and obtain adequate protection of future products through such intellectual property, the impact of general economic conditions, general co nditions in the pharmaceutical industry, the impact of the ongoing COVID - 19 pandemic on BELLUS Health's operations, plans and prospects, including to the initiation and completion of clin ical trials in a timely manner or at all, changes in the regulatory environment in the jurisdictions in which BELLUS Health does business, supply chain impacts, stock market volatili ty, fluctuations in costs, changes to the competitive environment due to consolidation, achievement of forecasted burn rate, achievement of forecasted preclinical study and clinic al trial milestones, reliance on third parties to conduct preclinical studies and clinical trials for BLU - 5937 and that actual results may differ from topline results once the final and quality - controlled verification of data and analyses has been completed. In addition, the length of BELLUS Health's product candidate's development process and its market size and commerc ial value are dependent upon a number of factors. Moreover, BELLUS Health's growth and future prospects are mainly dependent on the successful development, patient tolerability, regulatory approval, commercialization and market acceptance of its product candidate BLU - 5937 and other products. Consequently, actual future results and events may differ mater ially from the anticipated results and events expressed in the forward - looking statements. BELLUS Health believes that expectations represented by forward - looking statements are reason able, yet there can be no assurance that such expectations will prove to be correct. The reader should not place undue reliance, if any, on any forward - looking statements inc luded in this presentation. These forward - looking statements speak only as of the date made, and BELLUS Health is under no obligation and disavows any intention to update publ icl y or revise such statements as a result of any new information, future event, circumstances or otherwise, unless required by applicable legislation or regulation. Please see BELLUS Health's public filings with the Canadian securities regulatory authorities, including, but not limited to, its Annual Information Form, and the United States Securities and Exch ang e Commission, including, but not limited to, its Annual Report on Form 40 - F, for further risk factors that might affect BELLUS Health and its business.

 

 

Positive FDA End - of - Phase 2 Meeting and Announcing CALM Phase 3 Program • CALM Phase 3 Program designed to support approval of BLU - 5937 for treatment of refractory chronic cough (RCC): x Two pivotal Phase 3 trials, CALM - 1 and CALM - 2, with 3 expected arms: 25mg, 50mg and placebo BID x Primary efficacy endpoint of 24H cough frequency at 12 weeks in CALM - 1 and 24 weeks months in CALM - 2 » FDA alignment on using primary efficacy endpoint in population enriched for baseline cough frequency, similar to successful SOOTHE Phase 2b trial x Safety database supported by randomized extension of CALM - 1 and open label extension of CALM - 2 x First patient enrollment in CALM - 1 expected in Q4 2022 and pivotal topline data from CALM - 1 expected in 2H 2024 x Use of VitaloJAK cough monitoring system in CALM Phase 3 program; preliminary validation (n=30) study results using historical SOOTHE Ph2b data demonstrated 98.4% sensitivity • Well financed for Phase 3 following positive FDA End of Phase 2 meeting x $234M as of March 31 st provides cash runway to Q4 2024 and through top - line data from CALM - 1 Positive FDA End - of - Phase 2 meeting with clear path forward for BLU - 5937’s CALM Phase 3 program in refractory chronic cough 3

 

 

CALM Program: Study Design Two randomized, double - blind, placebo - controlled parallel arm trials with 2 active doses POPULATION • Refractory/unexplained chronic cough • Cough ≥1 year • Enriched for baseline cough frequency • CALM - 1 and CALM - 2: ∼ 675 participants each PRIMARY EFFICACY ENDPOINT • 24H cough frequency (CF) in enriched population 4

 

 

CALM Program: Enrichment Strategy CALM - 1 and CALM - 2 populations to be enriched for baseline cough frequency PRIMARY EFFICACY ENDPOINT: COUGH FREQUENCY IN PRIMARY POPULATION (90% POWER) • 24H cough frequency vs placebo in Primary Population SECONDARY EFFICACY ENDPOINTS (80% POWER) • Leicester Cough Questionnaire (LCQ), Cough Severity VAS (CS - VAS) and Chronic Cough Diary (CCD) in the Primary Population • 24H cough frequency vs placebo in Overall Population (Primary Population + subpopulation of Extended Population) PRIMARY POPULATION • ≥ 20 coughs/h (24H CF) • Equivalent to ≥25 cough/h (awake CF) population in successful SOOTHE Phase 2b trial EXTENDED POPULATION • < 20 coughs/h (24H CF) PBO BLU 5

 

 

CALM Phase 3: Dose Selection Well supported clinical rationale for 25 and 50mg BID dose selection: • No dose response observed between 25 and 200mg BID in RELIEF Ph2a study • 50mg BID lowest optimal dose in SOOTHE Phase 2b study • 50 and 200mg BID achieved 34% placebo - adjusted reduction in cough frequency • >90% of maximum predicted effect using PK/PD modeling in SOOTHE Phase 2b trial for 25 and 50mg BID doses: • 91.3% for 25mg BID • 96.3% for 50mg BID 6 Model - Predicted Relative Change From Baseline In 24H Cough Frequency After Multiple BLU - 5937 BID Dosing Placebo - adjusted percentage change in 24H cough frequency Dose range in SOOTHE Dose range in RELIEF CALM 25 50 12.5 200 BID Dose (mg)

 

 

• Statistical consultants recommended and FDA was aligned with using the negative binomial (NB) statistical method to analyze cough count data in CALM Phase 3 Program • NB expected to have a better statistical fit for count data like cough frequency • Previous method of log - transformation of cough data does not provide optimal statistical fit • Well documented use 1 - 7 in trials with analysis of count data • In BELLUS clinical datasets, NB provides better statistical fit: • Better manages variability and increases power • Minimal impact of extreme outliers CALM Phase 3: Statistical Methodology 7 In CALM Phase 3, use of Negative Binomial is expected to provide better power to detect treatment benefit and reduce risk of outliers skewing results 1. Ortega et al. (2014) N Engl J Med 371(13):1198 - 207. 2. Castro et al ( 2015) Lancet Resp Med 3(5):355 - 66. 3. Pavord et al. ( 2017) N Engl J Med 377(17):1613 - 1629. 4. Criner et al. (2019) N Engl J Med 381(11):1023 - 1034. 5. Smith et al. (CHEST) 2020 157(1):111 - 118. 6. Miller (2020) JAMA Neurol. 77(5):613 - 621. 7. Thiele (2021) JAMA Neurol 2021 Mar 1;78(3):285 - 292. Dose Δ p-value Δ p-value 12.5 mg -28% 0.0013 -21% 0.098 50 mg -33% 0.0005 -34% 0.0033 200 mg -32% 0.0021 -34% 0.0047 Dose Δ p-value Δ p-value 200 mg -23% 0.012 -20% 0.078 SOOTHE Main Population: ≥25 awake c/h SOOTHE Exploratory Population: 10-<25 awake c/h Negative Binomial Log Transformation SOOTHE Primary Efficacy Endpoint (Main Population): Placebo- adjusted 24H cough frequency at Day 28 SOOTHE Secondary Endpoint (Main + Exploratory Population): Placebo-adjusted 24H cough frequency at Day 28 Negative Binomial Log Transformation

 

 

• VitaloJAK is the cough recording and counting system used to capture the 24H cough frequency data in most cough trials • Used in BLU - 5937 and gefapixant RCC trials • Will be used in the CALM Phase 3 program • The Company and FDA aligned on validation of VitaloJAK cough frequency measurement to support the potential BLU - 5937 New Drug Application • Validation study comparing compressed vs non - compressed recordings in SOOTHE Phase 2b trial participants is on - going • Preliminary results from the first 30 recordings demonstrated a sensitivity of 98.4% with no systematic errors present • Complete results are expected in Q4 2022/Q1 2023 • Validation work has no impact on start of Phase 3 CALM Phase 3: VitaloJAK Cough Monitoring System 8 VitaloJAK Cough Monitoring Device

 

 

CALM Phase 3: Clinical Development Milestones and Expected Next Steps Topline results from CALM - 1 Phase 3 trial expected in 2H 2024 9 December 13 , 2021 SOOTHE Phase 2b Topline Results 2H 2021 2022 PH 2B June 2022 End - of - Phase 2 Meeting with FDA 4Q 2022 Expected First Patient Enrolled in Phase 3 CALM - 1 Trial 3Q 2022 Expected Final Protocols (IND Submission) EMA Feedback PH 3

 

 

10 Potential BLU - 5937 best - in - class profile for the treatment of refractory chronic cough, a large and growing market with limited competition BELLUS Today Potential for building pipeline targeting cough hypersensitivity in additional cough indications World - class team focused on delivering value to patients and shareholders 100% economics and global rights to BLU - 5937 intellectual property Positive FDA End - of - Phase 2 meeting with clear path forward for BLU - 5937’s Phase 3 CALM program in RCC