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17.04.2024 07:15:37 - dpa-AFX: EQS-Adhoc: Spexis announces extension of moratorium, receipt of an additional payment related to the sale of a preclinical antibiotics program and reversion of the lonodelestat license from Santhera (english)
Spexis announces extension of moratorium, receipt of an additional payment
related to the sale of a preclinical antibiotics program and reversion of the
lonodelestat license from Santhera
Spexis AG / Key word(s): Miscellaneous
Spexis announces extension of moratorium, receipt of an additional payment
related to the sale of a preclinical antibiotics program and reversion of
the lonodelestat license from Santhera
17-Apr-2024 / 07:15 CET/CEST
Release of an ad hoc announcement pursuant to Art. 53 LR
The issuer is solely responsible for the content of this announcement.
---------------------------------------------------------------------------
Ad hoc announcement pursuant to Art. 53 LR
Allschwil, Switzerland, April 17, 2024
Spexis announces extension of moratorium, receipt of an additional payment
related to the sale of a preclinical antibiotics program and reversion of
the lonodelestat license from Santhera
Spexis AG (SIX: SPEX), a clinical-stage biopharmaceutical company focused on
macrocycle therapeutics for rare diseases and oncology, today announced that
its request to extend its provisional moratorium has been granted for an
additional four months by the Western District Court of the Canton
Basel-Landschaft. This request was made as part of Spexis' efforts to
partner or divest non-core programs and assets and raise additional capital
in order to eventually emerge from moratorium.
In addition, Spexis sold all rights to a preclinical program of macrocycle
antibiotics developed by Spexis from a novel class (outer membrane protein
targeting antibiotics, or "OMPTAs") targeting Gram-negative bacteria,
including multidrug-resistant strains, under an asset purchase agreement to
Basilea Pharmaceutica International Ltd, Allschwil. The transaction was
first reported on 15 January 2024 and further reported on 8 February 2024
upon closing. In the meantime, Basilea has made the second of three total
potential payments to Spexis. This payment related to the completion of
transfer of the asset to Basilea.
Finally, Spexis announces that Santhera Pharmaceuticals Holding AG
(Pratteln, Switzerland) has terminated the February 2018 agreement wherein
Spexis (formerly Polyphor) out-licensed worldwide rights of lonodelestat,
its novel, inhaled neutrophil elastase inhibitor, to Santhera. Importantly,
the decision to terminate the license was taken in light of Santhera's
portfolio prioritization, and not as a result of any safety or efficacy data
having arisen from the Phase 1a or Phase 1b studies undertaken on
lonodelestat during the term of the license. All rights to lonodelestat and
all data generated by Santhera on lonodelestat during the term of the
license shall revert to Spexis during a brief transition period.
Jeff Wager, MD, Chairman & CEO of Spexis, said: "These three events
represent significant progress in the implementation of Spexis' moratorium
plan, and we continue to pursue the goal of ultimately emerging from
moratorium status. In addition, the reversion of lonodelestat rights to
Spexis also strengthens one of our core rare disease aereas - that of niche
respiratory conditions - wherein Spexis already has significant assets and
experience. We thank Santhera for the progress they made with lonodelestat
as a licensee, and based upon this progress, we plan to announce further,
innovative development plans as soon as practicable. We continue to have
great confidence in the novelty of our macrocycle technology as a drug
discovery platform to ultimately address significant unmet medical needs in
rare disease and oncology."
About Spexis
Spexis (SIX: SPEX) is a clinical-stage biopharmaceutical company based in
Allschwil, Switzerland, focused on macrocycle therapeutics for rare diseases
and oncology. For further information please visit: www.spexisbio.com.
About Spexis' Macrocycle Platforms
Spexis possesses what we regard as some of the most distinct, highly diverse
and very well characterized macrocycle libraries in the world, together with
deep data on same, developed over the course of more than 25 years of
research and development and significant investment. These include
PEMFinder(TM), which is comprised of peptidomimetic macrocycles, and
MACROFinder(TM), which are small molecule macrocycles. Each have distinct
applications depending on the targets in question, which can be both
extracelluar and intracellular targets. In addition to generating the
specific OMPTA candidates described in this press release, these platforms
have generated multiple other drug candidates in the Spexis pipeline,
including murepavidin, balixafortide, lonodelestat and others.
About Lonodelestat
Lonodelestat is a highly potent and selective peptide inhibitor of human
neutrophil elastase (hNE). Neutrophil elastase is an enzyme associated with
tissue inflammation, leading to degradation of the lung tissue in several
acute and chronic pulmonary diseases.
In preclinical studies, lonodelestat was effective in animal models of
neutrophil activation in lung tissue and of acute lung injury (ALI) (1, 2).
Currently available clinical data demonstrated that single and multiple
doses (Phase 1b) of lonodelestat when administered by inhalation via an
optimized eFlow® nebulizer (PARI Pharma GmbH) can lead to high drug
concentrations within the lung, resulting in inhibition of hNE in sputum of
patients, an enzyme associated with lung tissue inflammation (3). The Phase
1b study further confirmed the tolerability of lonodelestat after treatment
of up to four weeks in patients with CF. Lonodelestat may also show
therapeutic benefit for a range of neutrophilic pulmonary diseases with high
medical need such as non-CF bronchiectasis (NCFB), alpha-1 antitrypsin
deficiency (AATD), chronic obstructive pulmonary disease (COPD), acute
respiratory distress syndrome (ARDS) or primary ciliary dyskinesia (PCD),
amongst many others.
Lonodelestat currently has EU orphan drug designations (ODD) for the
treatment of CF as well as for AATD and PCD in both EU and US.
Both Spexis and Santhera acknowledges the support of the Cystic Fibrosis
Foundation (CFF) by providing funding for the conduct of the Phase 1a and 1b
safety trials with lonodelestat.
For further information please contact:
Disclaimer
This press release contains forward-looking statements which are based on
current assumptions and forecasts of Spexis management. Known and unknown
risks, uncertainties, and other factors could lead to material differences
between the forward-looking statements made here and the actual development,
in particular Spexis' results, financial situation, and performance. Readers
are cautioned not to put undue reliance on forward-looking statements, which
speak only of the date of this communication. Spexis disclaims any intention
or obligation to update and revise any forward-looking statements, whether
as a result of new information, future events or otherwise.
This press release can be downloaded from www.spexisbio.com
References
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End of Inside Information
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End of Announcement EQS News Service
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1882029 17-Apr-2024 CET/CEST
related to the sale of a preclinical antibiotics program and reversion of the
lonodelestat license from Santhera
Spexis AG / Key word(s): Miscellaneous
Spexis announces extension of moratorium, receipt of an additional payment
related to the sale of a preclinical antibiotics program and reversion of
the lonodelestat license from Santhera
17-Apr-2024 / 07:15 CET/CEST
Release of an ad hoc announcement pursuant to Art. 53 LR
The issuer is solely responsible for the content of this announcement.
---------------------------------------------------------------------------
Ad hoc announcement pursuant to Art. 53 LR
Allschwil, Switzerland, April 17, 2024
Spexis announces extension of moratorium, receipt of an additional payment
related to the sale of a preclinical antibiotics program and reversion of
the lonodelestat license from Santhera
* The Western District Court of the Canton Basel-Landschaft has granted
Spexis' request to extend its provisional moratorium by an additional 4
months.
* Spexis received the second of three potential payments as part of an
asset purchase agreement announced on Jan 15, 2024 totaling CHF 2
million.
* Santhera Pharmaceuticals Holding AG (Pratteln, Switzerland) has
terminated the license agreement relating to lonodelestat, Spexis'
inhaled neutrophil elastase inhibitor, as part of its portfolio review
and announced focus on its lead asset vamorolone.
Spexis AG (SIX: SPEX), a clinical-stage biopharmaceutical company focused on
macrocycle therapeutics for rare diseases and oncology, today announced that
its request to extend its provisional moratorium has been granted for an
additional four months by the Western District Court of the Canton
Basel-Landschaft. This request was made as part of Spexis' efforts to
partner or divest non-core programs and assets and raise additional capital
in order to eventually emerge from moratorium.
In addition, Spexis sold all rights to a preclinical program of macrocycle
antibiotics developed by Spexis from a novel class (outer membrane protein
targeting antibiotics, or "OMPTAs") targeting Gram-negative bacteria,
including multidrug-resistant strains, under an asset purchase agreement to
Basilea Pharmaceutica International Ltd, Allschwil. The transaction was
first reported on 15 January 2024 and further reported on 8 February 2024
upon closing. In the meantime, Basilea has made the second of three total
potential payments to Spexis. This payment related to the completion of
transfer of the asset to Basilea.
Finally, Spexis announces that Santhera Pharmaceuticals Holding AG
(Pratteln, Switzerland) has terminated the February 2018 agreement wherein
Spexis (formerly Polyphor) out-licensed worldwide rights of lonodelestat,
its novel, inhaled neutrophil elastase inhibitor, to Santhera. Importantly,
the decision to terminate the license was taken in light of Santhera's
portfolio prioritization, and not as a result of any safety or efficacy data
having arisen from the Phase 1a or Phase 1b studies undertaken on
lonodelestat during the term of the license. All rights to lonodelestat and
all data generated by Santhera on lonodelestat during the term of the
license shall revert to Spexis during a brief transition period.
Jeff Wager, MD, Chairman & CEO of Spexis, said: "These three events
represent significant progress in the implementation of Spexis' moratorium
plan, and we continue to pursue the goal of ultimately emerging from
moratorium status. In addition, the reversion of lonodelestat rights to
Spexis also strengthens one of our core rare disease aereas - that of niche
respiratory conditions - wherein Spexis already has significant assets and
experience. We thank Santhera for the progress they made with lonodelestat
as a licensee, and based upon this progress, we plan to announce further,
innovative development plans as soon as practicable. We continue to have
great confidence in the novelty of our macrocycle technology as a drug
discovery platform to ultimately address significant unmet medical needs in
rare disease and oncology."
About Spexis
Spexis (SIX: SPEX) is a clinical-stage biopharmaceutical company based in
Allschwil, Switzerland, focused on macrocycle therapeutics for rare diseases
and oncology. For further information please visit: www.spexisbio.com.
About Spexis' Macrocycle Platforms
Spexis possesses what we regard as some of the most distinct, highly diverse
and very well characterized macrocycle libraries in the world, together with
deep data on same, developed over the course of more than 25 years of
research and development and significant investment. These include
PEMFinder(TM), which is comprised of peptidomimetic macrocycles, and
MACROFinder(TM), which are small molecule macrocycles. Each have distinct
applications depending on the targets in question, which can be both
extracelluar and intracellular targets. In addition to generating the
specific OMPTA candidates described in this press release, these platforms
have generated multiple other drug candidates in the Spexis pipeline,
including murepavidin, balixafortide, lonodelestat and others.
About Lonodelestat
Lonodelestat is a highly potent and selective peptide inhibitor of human
neutrophil elastase (hNE). Neutrophil elastase is an enzyme associated with
tissue inflammation, leading to degradation of the lung tissue in several
acute and chronic pulmonary diseases.
In preclinical studies, lonodelestat was effective in animal models of
neutrophil activation in lung tissue and of acute lung injury (ALI) (1, 2).
Currently available clinical data demonstrated that single and multiple
doses (Phase 1b) of lonodelestat when administered by inhalation via an
optimized eFlow® nebulizer (PARI Pharma GmbH) can lead to high drug
concentrations within the lung, resulting in inhibition of hNE in sputum of
patients, an enzyme associated with lung tissue inflammation (3). The Phase
1b study further confirmed the tolerability of lonodelestat after treatment
of up to four weeks in patients with CF. Lonodelestat may also show
therapeutic benefit for a range of neutrophilic pulmonary diseases with high
medical need such as non-CF bronchiectasis (NCFB), alpha-1 antitrypsin
deficiency (AATD), chronic obstructive pulmonary disease (COPD), acute
respiratory distress syndrome (ARDS) or primary ciliary dyskinesia (PCD),
amongst many others.
Lonodelestat currently has EU orphan drug designations (ODD) for the
treatment of CF as well as for AATD and PCD in both EU and US.
Both Spexis and Santhera acknowledges the support of the Cystic Fibrosis
Foundation (CFF) by providing funding for the conduct of the Phase 1a and 1b
safety trials with lonodelestat.
For further information please contact:
For Investors: Stephen Jasper For Media: Dr. Stephan Feldhaus
Managing Director Gilmartin Feldhaus & Partner +41 79 865 9256
Group (1)stephen@gilmartinir.com (1)feldhaus@feldhaus-partner.ch 1.
1. mailto:feldhaus@feldhaus-partner.ch
mailto:stephen@gilmartinir.com
Disclaimer
This press release contains forward-looking statements which are based on
current assumptions and forecasts of Spexis management. Known and unknown
risks, uncertainties, and other factors could lead to material differences
between the forward-looking statements made here and the actual development,
in particular Spexis' results, financial situation, and performance. Readers
are cautioned not to put undue reliance on forward-looking statements, which
speak only of the date of this communication. Spexis disclaims any intention
or obligation to update and revise any forward-looking statements, whether
as a result of new information, future events or otherwise.
This press release can be downloaded from www.spexisbio.com
References
1. Sellier Kessler O et al. Effect of POL6014, a potent and selective
inhaled neutrophil elastase inhibitor, in a rat model of lung neutrophil
activation. Am J Respir Crit Care Med 2018; 197: A2988
2. Lagente V et al. A novel protein epitope mimetic (PEM) neutrophil
elastase (NE) inhibitor, POL6014, inhibits human NE-Induced acute lung
injury in mice. Am J Respir Crit Care Med 2009; 179: A5668
3. Barth P et al. Single dose escalation studies with inhaled POL6014, a
potent novel selective reversible inhibitor of human neutrophil
elastase, in healthy volunteers. J Cyst Fibros 2020; 19: 299-304
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End of Inside Information
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Language: English
Company: Spexis AG
Hegenheimermattweg 125
4123 Allschwil
Switzerland
Phone: +41 61 567 1600
Fax: +41 61 567 1601
E-mail: info@spexisbio.com
Internet: www.spexisbio.com
ISIN: CH0106213793
Valor: SPEX
Listed: SIX Swiss Exchange
EQS News ID: 1882029
End of Announcement EQS News Service
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1882029 17-Apr-2024 CET/CEST
