ColiFin (colistimethate sodium inhalation) / Pari, Spexis - LARVOL DELTA

Tolerability and Safety of Inhaled Colistimethate Sodium (CMS) Administered Once Daily Compared to Twice Daily Dosing in Adult and Adolescent Subjects with Cystic Fibrosis and Chronic Pseudomonas Aeruginosa Lung Infection (COPILOT) (ANZCTR) - P3 | N=38 | Active, not recruiting | Sponsor: Spexis Australia Pty Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed • Cystic Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

InhalEd ColiFin® in adult bRonchiectasis pAtients with new asymptomatic PseuDomonas aerugInosa infeCtion– an open-lAbel, proof of concepT- randomizEd controlled trial (ERADICATE) (WBC 2026) - No abstract available

Clinical • Bronchiectasis • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Effect of discontinuation and reduction of respiratory cotherapies on the effectiveness of CFTR modulators. (PubMed, J Cyst Fibros) - "This real-world study revealed a high rate of respiratory cotherapy discontinuation or reduction during the year following LUM/IVA or IVA initiation, without measurable clinical impact."

Journal

Tolerability and Safety of Inhaled Colistimethate Sodium (CMS) Administered Once Daily Compared to Twice Daily Dosing in Adult and Adolescent Subjects with Cystic Fibrosis and Chronic Pseudomonas Aeruginosa Lung Infection (COPILOT) (ANZCTR) - P3 | N=38 | Recruiting | Sponsor: Spexis Australia Pty Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Cystic Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Tolerability and Safety of Inhaled Colistimethate Sodium (CMS) Administered Once Daily Compared to Twice Daily Dosing in Adult and Adolescent Subjects with Cystic Fibrosis and Chronic Pseudomonas Aeruginosa Lung Infection (COPILOT) (ANZCTR) - P3 | N=38 | Not yet recruiting | Sponsor: Enbiotix Inc

New P3 trial • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Spexis provides business update and announces financial results for the first half of 2023 (GlobeNewswire) - "Spexis closed capital commitments totaling USD $7.5 million supporting Phase 3 ColiFin program in cystic fibrosis (CF) infections....The company has worldwide rights to ColiFin ex-Europe and is preparing a Phase 3 program in CF patients which includes the COPILOT safety and tolerability trial, and the COPA efficacy trial. COPILOT is expected to initiate prior to the end of 2023."

Financing • New P3 trial • Cystic Fibrosis

Spexis announces USD $2.5 million capital commitment to support the upcoming Phase 3 ColiFin® studies (GlobeNewswire) - "Spexis AG...today announced a capital commitment totaling USD $2.5 million with participation from SPRIM Global Investments (SGI) and institutional investors to fund the upcoming Phase 3 ColiFin® studies, beginning with the COPILOT study which is expected to initiate in the third quarter of 2023. The USD $2.5 million capital commitment will be in the form of USD $1.0 million in secured, interest-bearing debt with partial warrant coverage from SGI and USD $1.5 million subordinated debt mandatorily converting into equity from institutional investors....“This new capital allows us to not only initiate the COPILOT study in the third quarter, but will also allow for continued progress across start-up activities for COPA, the second part of our planned pivotal efficacy and safety Phase 3 study.”"

Financing • New P3 trial • Cystic Fibrosis

Spexis provides business update and announces financial results for the full year 2022 (GlobeNewswire) - "Lead Program: ColiFin®....COPILOT has study start-up activities ongoing and is expected to enroll its first patient in Q3 2023 with data expected in the first quarter of 2024....Spexis intends to advance iMPV into Phase 1b/2 studies in CF patients in 2023, with the potential to expand development efforts into moderate to severe non-CF bronchiectasis ('nCFBE'), a significant additional market opportunity....R&D expenditures are expected to increase in 2023 as the company launches the Phase 3 trial for ColiFin®...Spexis’ cash position as of December 31, 2022 was CHF 1.8 million (cash and cash equivalents)."

Financing • New P1/2 trial • P3 data • Bronchiectasis • Non‐Cystic Fibrosis Bronchiectasis

Spexis announces closing of capital commitment of USD 4.5 million from SPRIM Global Investments (SGI) to enable initiation of ColiFin Phase 3 study (GlobeNewswire) - "Spexis AG...announced that the company has finalized a capital commitment from SPRIM Global Investments (SGI) totaling USD 4.5 million in the form of secured, interest-bearing debt with partial warrant coverage and subordinated debt mandatorily converting into equity. Proceeds from the capital commitment will enable the initiation of the Phase 3 COPILOT study, the first part of the registrational clinical studies planned for ColiFin®. The COPILOT study, which will enroll 38 patients and evaluate and confirm the use of once or twice daily dosing for COPA, the second part of the planned pivotal efficacy and safety Phase 3 study of ColiFin®, has study start-up activities ongoing, and is expected to enroll its first patient in June 2023."

Financing • New P3 trial • Chronic Obstructive Pulmonary Disease • Cystic Fibrosis • Respiratory Diseases

Spexis provides business update and announces financial results for the first half of 2022 (GlobeNewswire) - "Lead program, ColiFin: The process of site initiation is proceeding well, and the COPILOT trial is now planned to start in H1 of 2023, and aims to provide dosing data for COPA, which is now expected to initiate in H2 2023....Inhaled murepavadin (iMPV)...is currently in a Phase 1 study in healthy volunteers to evaluate safety and tolerability of single and multiple ascending doses (SAD/MAD). The study is ongoing and top-line data are expected by the end of this year. Potential indications that could be eventually targeted with iMPV include CF, nCFBE and COPD in patients with chronic PA infection."

New P3 trial • P1 data • Cystic Fibrosis • Infectious Disease • Respiratory Diseases

A study to test how well inhalation of Colistimethate Sodium once a day is tolerated and how safe it is compared with inhalation of Colistimethate Sodium two times a day in adult and children with Cystic Fibrosis and lung infection (COPILOT) Ez a vizsgálat annak tesztelésére szolgál, hogy a kolisztimetát-nátrium napi egyszeri belélegzése mennyire tolerálható, és mennyire biztonságos a... (clinicaltrialsregister.eu) - P3 | N=38 | Ongoing | Sponsor: EnBiotix, Inc.

New P3 trial • Cystic Fibrosis • Dermatology • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

EnBiotix, Inc. Closes $11M Pre-Merger Financing (GlobeNewswire) - "EnBiotix...today announced the closing of an $11M pre-merger, convertible note round of financing ('the Financing') comprised of Vectura Group plc, the Cystic Fibrosis Foundation and Sanford Biosciences LLC....The Cystic Fibrosis Foundation ('the Foundation') joined the investment round primarily to fund confirmatory long-term safety studies related to EnBiotix’s lead product ColiFin®, which would be conducted in parallel with a planned global Phase 3 clinical study....EnBiotix expects to move ColiFin® into Phase 3 clinical trials in 2022....Proceeds from the Financing will also be directed towards R&D expenses related to EnBiotix’s other product development programs and ongoing and future legal, accounting and other general and administrative expenses related to its planned merger with Polyphor AG (SIX:POLN), which is expected to close by year-end 2021."

M&A • New P3 trial • Cystic Fibrosis

Polyphor and EnBiotix Announce Signing of Merger Agreement and Sale of Inhaled Murepavadin to EnBiotix (Issuer Direct) - "Polyphor...and EnBiot...announced that the companies have signed a merger agreement pursuant to which Polyphor acquires all of the outstanding capital stock of EnBiotix in exchange for shares of Polyphor common stock....Following closing, expected in Q4 2021, Polyphor will be renamed and is expected to trade under a new ticker symbol on the Swiss Stock Exchange....Initiation of a single Phase III trial of ColiFin(R) for the treatment of CF patients, upon completion of which the combined company plans to seek FDA approval in the US. Initiation of a Phase I trial of inhaled murepavadin for the treatment of CF patients...the companies have signed a definitive asset purchase agreement where EnBiotix acquires Polyphor's inhaled murepavadin at an agreed valuation of USD 10 million in exchange for 2'599'655 of common shares of EnBiotix (15.4% fully diluted of EnBiotix). The closing of this agreement is expected in September 2021 and prior to the expected closing of the merger."

M&A • Trial status • Cystic Fibrosis • Infectious Disease