UNITED STATES
SECURITIES AND EXCHANGE
COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE
ISSUER PURSUANT TO RULE 13a-16 OR 15b-16 OF THE SECURITIES EXCHANGE ACT OF 1934
For the month of November
2023
Commission File Number: 001-41359
Belite Bio, Inc
(Exact name of registrant
as specified in its charter)
Not Applicable
(Translation of Registrant´s
name into English)
12750 High Bluff Drive Suite 475,
San Diego, CA 92130
(Address of principal executive
office)
Indicate by check mark whether
the registrant files or will file annual reports under cover Form 20-F or Form 40-F. Form 20-F x
Form 40-F ¨
Indicate by check mark if the
Registrant is submitting this Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): Yes ¨
No x
Indicate by check mark if the
Registrant is submitting this Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): Yes ¨
No x
Indicate by check mark whether
the registrant by furnishing the information contained in this Form 6-K is also thereby furnishing the information to the Commission
pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934
Yes ¨ No
x
On November 6, 2023, Belite Bio, Inc issued a press release entitled
“Belite Bio Presents Results from a 24-month, Phase 2 Study of Tinlarebant in Childhood-onset Stargardt Disease at the AAO Annual
Meeting”. A copy of this press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
This Report on Form 6-K shall be deemed to be incorporated by reference
into all effective registration statements filed by the registrant under the Securities Act of 1933, and shall be a part thereof from
the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
Exhibit
Index
Exhibit
99.1 — Press Release
SIGNATURE
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.
|
Belite Bio, Inc |
|
|
|
|
By: |
/s/ Yu-Hsin Lin |
|
Name: |
Yu-Hsin Lin |
|
Title: |
Chief Executive Officer and Chairman |
Date: November 6, 2023
Exhibit 99.1
Belite Bio Presents Results from a 24-month,
Phase 2 Study of Tinlarebant in Childhood-onset Stargardt Disease at the AAO Annual Meeting
| · | Tinlarebant (a/k/a LBS-008) is Belite Bio’s orally administered
tablet intended to slow disease progression in patients affected with Stargardt Disease (STGD1) and Geographic Atrophy (GA) in advanced
Dry Age-related Macular Degeneration (Dry AMD) |
| · | Tinlarebant was safe and well-tolerated in all subjects throughout
the 24-month treatment period |
| · | A comparison of the 24-month DDAF lesion growth between Tinlarebant-treated
subjects and ProgStar participants possessing similar baseline characteristics (aged ≤18 years) showed a sustained lower DDAF lesion
growth in Tinlarebant-treated subjects over the 24-month treatment period (p<0.001) |
| · | 42% of Tinlarebant-treated subjects (5 out of 12) did not develop
atrophic retinal lesions during the 24-month treatment period |
| · | Full enrollment of a two-year global Phase 3 study of Tinlarebant
in childhood-onset STGD1 (the “DRAGON” study) is complete |
SAN DIEGO, November 6, 2023 - Belite Bio,
Inc (NASDAQ: BLTE), a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting
degenerative retinal diseases that have significant unmet medical need, presented final data from a 24-month, Phase 2 study of Tinlarebant
in adolescent STGD1 (“LBS-008-CT02”) at the American Association of Ophthalmology (AAO) Annual Meeting.
“Tinlarebant’s final Phase 2 results represent a significant
milestone for Belite Bio and provide additional foundational support for the work being conducted across our trials,” said Dr. Tom
Lin, Chairman and CEO of Belite Bio. “The final Phase 2 data continue to demonstrate Tinlarebant’s safety profile and show
a sustained lower DDAF lesion growth compared to ProgStar participants over the two-year treatment period. We hope to see similar data
in the ongoing Phase 3 DRAGON study, further supporting Tinlarebant as a promising oral treatment for STGD1 patients.”
Professor John Grigg, the study’s Principal Investigator and
Head Specialty of Ophthalmology at the University of Sydney and Consultant Ophthalmologist at the Sydney Children’s Hospitals Network
at Westmead and Sydney Eye Hospital, presented the final study data. “We are very encouraged by the promising 24-month treatment
final results from this Phase 2 study. The natural progression of childhood-onset STGD1 is characterized by a rapid visual decline and
fast disease progression leading to permanent visual loss at a very young age. We are pleased that the Phase 2 final data continued to
demonstrate the slowing of disease progression in the study cohort and stabilization of several structural and functional parameters,
including stabilization of visual acuity.”
A total of 12 adolescent STGD1 subjects aged 12-18 years completed
24 months of treatment in the Phase 2 study of Tinlarebant.
Key study findings:
| · | Tinlarebant was safe and well-tolerated with no withdrawals due to adverse events. |
| · | Retinal imaging showed that 5 of 12 subjects remained free of atrophic retinal lesions (referred to as definitely decreased autofluorescence
or DDAF) after 24 months of Tinlarebant treatment. |
| · | A comparison of the 24-month DDAF lesion growth between Tinlarebant-treated subjects and ProgStar participants possessing similar
baseline characteristics (aged ≤18 years) showed a sustained lower DDAF lesion growth in Tinlarebant-treated subjects over the 24-month
treatment period (p<0.001). |
| · | Visual acuity was stabilized in majority of subjects during the study with a mean loss of five letters following 24 months of treatment
(a loss of <10 letters is not considered clinically significant). |
| · | A
copy of the presentation slides is available here (LINK). |
*Only 50 patients from ProgStar Cohort (aged ≤18)
were included in the analysis due to one subject having ungradable screening FAF data.
| 1. | Strauss RW, Ho A, Muñoz B, et al. The Natural History of the Progression of Atrophy Secondary to Stargardt Disease (ProgStar)
Studies: Design and Baseline Characteristics: ProgStar Report No. 1. Ophthalmology. 2016;123(4):817-28. |
| 2. | Strauss RW, Muñoz B, Ho A, et al. Progression of Stargardt Disease as Determined by Fundus Autofluorescence in the Retrospective
Progression of Stargardt Disease Study (ProgStar Report No. 9). JAMA Ophthalmol. 2017; 135(11):1232-1241. |
About the DRAGON Study
The 2-year, Phase 3 study (DRAGON) is a Multi-Center, Randomized,
Double-Masked, Placebo-Controlled Study to Evaluate the Safety and Efficacy of TinlaRebant in the Treatment of StArGardt
Disease in AdOlesceNt Subjects. This study has completed recruitment (104 subjects) and one-year interim data are expected
during mid to late 2024. For more information, visit clinicaltrials.gov at https://www.clinicaltrials.gov/ct2/show/NCT05244304?term=belite+bio&draw=2&rank=1).
About Tinlarebant
(a/k/a LBS-008)
Tinlarebant is a novel oral therapy that is
intended to reduce the accumulation of vitamin A-based toxins (known as bisretinoids) that cause retinal disease in STGD1 and
also contribute to disease progression in GA, or advanced Dry AMD. Bisretinoids are by-products of the visual cycle, which is
dependent on the supply of vitamin A (retinol) to the eye. Tinlarebant works by reducing and maintaining levels of serum retinol
binding protein 4 (RBP4), the sole carrier protein for retinol transport from the liver to the eye. By modulating the amount of
retinol entering the eye, Tinlarebant reduces the formation of bisretinoids. Tinlarebant has been granted Fast Track Designation and
Rare Pediatric Disease designation in the U.S., and Orphan Drug Designation in the U.S. and Europe for the treatment of STGD1.
Stargardt Disease (STGD1)
STGD1 is the most common inherited retinal dystrophy
(causing blurring or loss of central vision) in both adults and children. The disease is caused by mutations in a retina-specific gene
(ABCA4), which results in progressive accumulation of bisretinoids leading to retinal cell death and progressive loss of central
vision. The fluorescent properties of bisretinoids and the development of retinal imaging systems have helped ophthalmologists identify
and monitor disease progression. Currently, there are no FDA approved treatments for STGD1.
Importantly, STGD1 and GA, or advanced Dry AMD,
share a similar pathophysiology, which is characterized by the excessive accumulation of bisretinoids, retinal cell death, and progressive
loss of vision. Vision loss occurs slowly, despite peripheral expansion of “dead retina,” until the disease reaches the center
of the eye (the macula). Therefore, Belite Bio intends to evaluate safety and efficacy of Tinlarebant in GA patients in a 2-year Phase
3 study (PHOENIX).
GA in advanced Dry Age-related Macular Degeneration
(Dry AMD)
Dry AMD is a leading cause of vision loss in older
adults. Geographic Atrophy, or GA, is the advanced stage of Dry AMD. Currently, there are no FDA approved orally administered treatments
for GA and no FDA approved therapies for the other stages of Dry AMD other than GA. There are an estimated 20 million AMD patients in
the U.S. and over 196 million patients worldwide with an estimated global direct healthcare cost of US$255 billion.
About Belite Bio
Belite Bio is a clinical-stage biopharmaceutical
drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet
medical need, such as STGD1 and GA in advanced Dry AMD, in addition to specific metabolic diseases. For more information, follow us on
Twitter, Instagram, LinkedIn, Facebook or visit us at www.belitebio.com.
Important Cautions Regarding Forward Looking Statements
This press release contains forward-looking
statements about future expectations and plans, as well as other statements regarding matters that are not historical facts. These statements
include but are not limited to statements regarding the potential implications of clinical data for patients, and Belite Bio’s advancement
of, and anticipated preclinical activities, clinical development, regulatory milestones, and commercialization of its product candidates,
and any other statements containing the words “expect”, “hope” and similar expressions. Actual results may differ
materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited
to Belite Bio’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates,
which may not support further development or regulatory approval; the content and timing of decisions made by the relevant regulatory
authorities regarding regulatory approval of Belite Bio’s drug candidates; the potential efficacy of Tinlarebant, as well as those
risks more fully discussed in the “Risk Factors” section in Belite Bio’s filings with the U.S. Securities and Exchange
Commission. All forward-looking statements are based on information currently available to Belite Bio, and Belite Bio undertakes no obligation
to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except
as may be required by law.
Media and Investor Relations Contacts:
Jennifer Wu ir@belitebio.com
Argot Partners belitebio@argotpartners.com
Grafico Azioni Belite Bio (NASDAQ:BLTE)
Storico
Da Apr 2024 a Mag 2024
Grafico Azioni Belite Bio (NASDAQ:BLTE)
Storico
Da Mag 2023 a Mag 2024