Spero Therapeutics, Inc. (Nasdaq:SPRO), a multi-asset
clinical-stage biopharmaceutical company focused on identifying,
developing and commercializing novel treatments for
multidrug-resistant (MDR) bacterial infections, and Everest
Medicines announced today that they have entered into a
collaboration to develop, manufacture and commercialize SPR206 in
Greater China, South Korea and certain Southeast Asian countries
(the “Territory”), along with an exclusive option to rights to
SPR741 in the Territory.
SPR206 and SPR741, two intravenous
(IV)-administered product candidates from Spero’s Potentiator
Platform, are being developed as innovative options to treat MDR
Gram-negative bacterial infections. Based on microbiological
and in vivo testing, Spero believes that SPR206 has the potential
to offer a broad-spectrum of activity, including against
extensively drug-resistant (XDR) bacterial strains, together with
improved safety and tolerability compared with other molecules in
its class. Spero initiated a Phase 1 clinical trial of SPR206 in
December 2018, designed as a double-blind, placebo-controlled,
ascending dose, multi-cohort study in healthy subjects, and expects
top-line data from this trial in the second half of 2019.
Data from investigational new drug (IND)-enabling studies, together
with data presented at the ESCMID/ASM Conference in September 2018,
collectively demonstrate SPR206’s favorable safety profile and in
vitro activity against MDR Gram-negative pathogens, including
carbapenem-resistant Enterobacteriaceae, Acinetobacter baumannii
and Pseudomonas aeruginosa. SPR741 is a novel compound designed to
expand the spectrum and enhance the potency of existing
antibiotics. SPR741 completed a Phase 1b drug-drug
interaction clinical trial in July 2018, which demonstrated safety
and pharmacokinetic compatibility of SPR741 when co-administered
with beta-lactam antibiotics.
Spero, through certain of its wholly owned
subsidiaries, has granted Everest an exclusive license to develop,
manufacture, and commercialize SPR206 in the Territory.
Everest also has a 12-month exclusive option to rights to SPR741 in
the Territory. A Joint Development Committee will be
established between the companies to coordinate and review the
development, manufacturing and commercialization plans with respect
to SPR206 in the Territory. Spero will receive an upfront payment
of $2 million and is eligible to receive milestone payments of up
to an additional $59.5 million upon achievement of specified
clinical, regulatory and commercial milestones related to SPR206,
of which Spero anticipates receiving at least $2 million in
near-term milestones during 2019. Furthermore, Spero will be
eligible to receive high single-digit to low double-digit royalties
on any sales of SPR206 products in the Territory following
regulatory approval. Everest will also pay Spero a $1 million
upfront fee for its exclusive 12-month option to rights to
SPR741.
“We look forward to working with Everest
Medicines to further develop and bring SPR206 to market in Greater
China, South Korea and Southeast Asia in an effort to address the
growing, global problem of antibiotic resistance,” said Ankit
Mahadevia, M.D., CEO of Spero Therapeutics. “Everest
shares our passion and commitment to developing these important,
novel medications. Having a local partner who understands the
market dynamics and reimbursement landscape will significantly
assist Spero’s efforts to develop and commercialize these product
candidates in Asia. Additionally, funding from this
transaction will provide additional resources to advance our robust
pipeline of products that address unmet medical needs.”
“Bacterial drug resistance is a critical health
issue and innovative new classes of antibiotics is an area of
urgent unmet need,” said Sean Cao, Interim CEO at Everest
Medicines. “We partner with companies that develop innovative
medicines and have large commercial potential in Asia. Development
of safer polymyxins with a broad spectrum of antimicrobial activity
including extensively resistant bacteria may provide a life-saving
treatment to patients with limited or no alternative treatment
options.”
About the Spero Potentiator Platform –
SPR206 and SPR741
The Potentiator Platform molecules are designed
to treat Gram-negative bacterial infections through the molecule’s
interactions with the bacterium’s outer membrane. The Potentiator
Platform molecules exhibit this effect as a monotherapy or by
co-administration with existing antibiotics. Spero currently has
two Potentiator Platform drug candidates – SPR206, a direct acting
IV-administered agent that has demonstrated broad
Gram-negative antibacterial activity; and SPR741, an
IV-administered agent that has demonstrated Gram-negative
antibacterial activity when co-administered with existing
antibiotics. Both have demonstrated activity against
Gram-negative bacteria, including organisms identified by
the Centers for Disease Control and Prevention and
the World Health Organization as urgent and serious threats to
human health. SPR206 is designed to have antibiotic activity as a
single agent against MDR and XDR bacterial strains, including
carbapenem-resistant Pseudomonas aeruginosa, Acinetobacter
baumannii and Enterobacteriaceae. Spero initiated a Phase
1 trial of SPR206 in December 2018 and anticipates top-line data
from the trial in the second half of 2019. In preclinical
studies, SPR741 was able to potentiate over two-dozen existing
antibiotics by expanding their activity against Gram-negative
pathogens. SPR741 has been evaluated in two Phase 1 clinical
trials in healthy volunteers supporting its safety and
tolerability. Spero believes that its current
intellectual property portfolio and pending patent applications
will provide global protection, including China, the United States
and Europe for SPR741 and SPR206 through 2038 and 2039,
respectively.
About Everest Medicines
Everest Medicines is an emerging markets
biopharmaceutical company focused on developing and commercializing
transformative pharmaceutical products that address critical unmet
medical needs for patients across Greater China and other Asian
territories. The Everest Medicines team has deep expertise and an
extensive track record of high-quality clinical development,
regulatory affairs, CMC, business development and operations with
leading global pharmaceutical companies, and in our territories of
focus.
About Spero
Spero is a multi-asset, clinical-stage
biopharmaceutical company focused on identifying, developing and
commercializing novel treatments for MDR bacterial infections.
Spero’s lead product candidate, SPR994, is
designed to be the first broad-spectrum oral carbapenem-class
antibiotic for use in adults to treat MDR Gram-negative
infections.
Spero also has a platform technology known as
its Potentiator Platform that it believes will enable it to develop
drugs that will expand the spectrum and potency of existing
antibiotics, including formerly inactive antibiotics, against
Gram-negative bacteria. Spero’s lead product candidates generated
from its Potentiator Platform are two IV-administered agents,
SPR206 and SPR741, that are designed to treat MDR Gram-negative
infections in the hospital setting.
Spero is also advancing SPR720, its novel oral
therapy product candidate designed for the treatment of pulmonary
non-tuberculous mycobacterial infection.
For more information,
visit https://sperotherapeutics.com.
SPR206 Research Support
This project has been funded in part with
Federal funds from the National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, Department of Health and Human Services, under
Contract No. HHSN272201500014C.
Forward-Looking Statements
This press release may contain forward-looking
statements. These statements include, but are not limited to,
statements about the future development or commercialization of
SPR206 and SPR741 in Greater China, South Korea and certain
Southeast Asian countries, the potential receipt of milestone
payments, as well as royalties on potential future sales of SPR206,
under the license with Everest Medicines, the initiation, timing,
progress and results of Spero’s preclinical studies and clinical
trials and its research and development programs, including
statements regarding management’s assessment of the results of such
preclinical studies and clinical trials, the timing of clinical
data, including the availability of top-line data from the Phase 1
clinical trial of SPR206, Spero’s cash forecast and anticipated
expenses, the sufficiency of its cash resources and the
availability of additional non-dilutive funding from governmental
agencies beyond any initially funded awards. In some cases,
forward-looking statements can be identified by terms such as
“may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,”
“could,” “intent,” “target,” “project,” “contemplate,” “believe,”
“estimate,” “predict,” “potential” or “continue” or the negative of
these terms or other similar expressions. Actual results may
differ materially from those indicated by such forward-looking
statements as a result of various important factors, including
Spero’s dependence on Everest Medicines to timely and successfully
develop, manufacture and commercialize SPR206 in Greater China,
South Korea and certain Southeast Asian countries; the fact that
Spero may not receive any milestone or royalty payments from
Everest Medicines; whether results obtained in preclinical studies
and clinical trials will be indicative of results obtained in
future clinical trials; whether Spero’s product candidates,
including SPR206, will advance through the preclinical development
and clinical trial process on a timely basis, or at all, taking
into account the effects of possible regulatory delays, slower than
anticipated patient enrollment, manufacturing challenges, clinical
trial design and clinical outcomes; whether the results of such
trials will warrant submission for approval from the U.S. Food
and Drug Administration or equivalent foreign regulatory
agencies; whether Spero’s cash resources will be sufficient to fund
its continuing operations for the periods and/or trials
anticipated; Spero’s ability to continue obtaining and maintaining
intellectual property protection for its product candidates; and
other factors discussed in the “Risk Factors” set forth in filings
that Spero periodically makes with the U.S. Securities
Exchange Commission. The forward-looking statements included
in this press release represent Spero’s views as of the date of
this press release. Spero anticipates that subsequent events
and developments will cause its views to change. However,
while Spero may elect to update these forward-looking statements at
some point in the future, it specifically disclaims any obligation
to do so. These forward-looking statements should not be
relied upon as representing Spero’s views as of any date subsequent
to the date of this press release.
Spero Investor and Media
Contact: Sharon Klahre Director,
Investor Relations 857-242-1547IR@sperotherapeutics.com
Everest Medicines Media Contact: James Heins
Senior Vice President203-682-8251James.Heins@icrinc.com
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