Spexis reports robust safety and pharmacokinetic results

Ad hoc press release pursuant to art. 53 LR

  • Inhaled murepavadine was well tolerated at all dose levels
  • Program derived from the Spexis macrocycle platform
  • Data Support Transition to Phase 2 in Cystic Fibrosis and Non-Cystic Fibrosis Bronchiectasis Pulmonary Infections

ALLSCHWIL, Switzerland, Jan. 09, 2023 (GLOBE NEWSWIRE) — Spexis AG (SIX: SPEX), a clinical-stage biopharmaceutical company focused on rare diseases and oncology, today announced the successful completion of the first human clinical trial with the new class of murepavadin antibiotics, administered by inhaled orally (iMPV). iMPV is a macrocycle compound derived from Spexis’ proprietary platform and specifically targets the outer membrane of Pseudomonas aeruginosa (P. aeruginosa) including activity against highly resistant strains. P. aeruginosa it is the key pathogen in cystic fibrosis (CF) lung infections. The study was supported by the European Innovative Medicines Initiative (IMI).

Juergen Froehlich, MD, Chief Medical Officer of Spexis, said: “Early clinical data with our inhaled murepavadine is promising as we work to bring more effective and safer treatments for severe lung infections to patients who need them, including people with cystic fibrosis and no Bronchiectasis – CF. The strong collaboration established between Spexis and the European Innovative Medicines Initiative enabled us to conduct this important first human study and we are grateful for the continued support of IMI. We look forward to continuing to advance this product candidate into clinical development.”

This Phase 1 study was a single-center, double-blind, randomized, placebo-controlled study to investigate the safety, tolerability, and pharmacokinetics of single escalating doses of iMPV in healthy volunteers.

A total of 39 subjects participated in the trial. In Part A of the study, three single dose levels (12.5 mg, 25 mg, and 50 mg iMPV) were evaluated in four subjects per cohort. In Part B, single doses of 75 mg, 150 mg, and 300 mg were evaluated in nine subjects per cohort. The pharmacokinetics (PK) of iMPV was evaluated in blood samples and in epithelial lining fluid (ELF) obtained by bronchoalveolar lavage.

Analyzes of the blinded preliminary data from this study showed that iMPV was well tolerated at all dose levels, with all subjects completing the inhalation. No clinically relevant signs of upper airway irritation and no serious adverse events were reported. Serial pulmonary function tests were normal and did not show airway narrowing after iMPV administration. Vital signs, ECG, and safety laboratory data were within the normal range.

At the highest single dose tested, the systemic bioavailability of MPV was less than 5% and peak plasma concentrations were observed 1-2 hours after initiation of inhalation. In the ELF, the MPV concentration at the 24-h timepoint was still above the concentration that would have inhibited 90% growth of P. aeruginosa isolates (MIC90) obtained from people with CF.

These data indicate that iMPV leads to high inhibitory concentrations in the airways of the lung, while systemic levels of MPV remain substantially lower than the plasma level observed in previous clinical studies with intravenous administration of MPV. This favorable tolerability, safety, and observed concentration profile of MPV after inhalation in the Phase 1 study meets the company’s expectations and paves the way for further clinical trials of iMPV in people with CF or non-CF bronchiectasis.

About Spexis

Spexis (SIX: SPEX) is a clinical-stage biopharmaceutical company headquartered in Allschwil, Switzerland, focused on rare diseases and oncology. For more information visit: www.spexisbio.com.

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This press release contains forward-looking statements that are based on the current assumptions and forecasts of Spexis management. Known and unknown risks, uncertainties and other factors could cause the forward-looking statements made herein to differ materially from actual development, particularly the results, financial condition and performance of Spexis. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this communication. Spexis disclaims any intent or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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