0001193125-22-234074.txt : 20220830 0001193125-22-234074.hdr.sgml : 20220830 20220830160131 ACCESSION NUMBER: 0001193125-22-234074 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20220830 FILED AS OF DATE: 20220830 DATE AS OF CHANGE: 20220830 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Connect Biopharma Holdings Ltd CENTRAL INDEX KEY: 0001835268 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: E9 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-40212 FILM NUMBER: 221214507 BUSINESS ADDRESS: STREET 1: SCIENCE & TECH PARK, EAST R&D BLDG, 3 FL STREET 2: EAST R&D BUILDING, 3RD FLOOR CITY: 6 BEIJING WEST ROAD, TAICANG STATE: F4 ZIP: 215400 BUSINESS PHONE: 86 512 5357 7866 MAIL ADDRESS: STREET 1: SCIENCE & TECH PARK, EAST R&D BLDG, 3 FL STREET 2: EAST R&D BUILDING, 3RD FLOOR CITY: 6 BEIJING WEST ROAD, TAICANG STATE: F4 ZIP: 215400 6-K 1 d304629d6k.htm 6-K 6-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 6-K

 

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of August 2022

Commission File Number: 001-40212

 

 

Connect Biopharma Holdings Limited

(Translation of registrant’s name into English)

 

 

12265 El Camino Real, Suite 350

San Diego, CA 92130

(Address of principal executive office)

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F  ☒            Form 40-F  ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):  ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):  ☐

 

 

 

INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K

On August 30, 2022, Connect Biopharma Holdings Limited (the “Company”) announced the completion of its Phase 1 clinical trial of CBP-174, a highly selective, peripherally acting H3 receptor (H3R) antagonist drug candidate. The Company is developing CBP-174 for oral administration to treat chronic pruritus associated with allergic and inflammatory skin conditions, including atopic dermatitis.

The Phase 1 clinical trial was a randomized, double-blind, placebo-controlled, single ascending dose study to assess safety, tolerability, and pharmacokinetics of CBP-174 in healthy adults. The study included eight dose escalation cohorts and one extension cohort with administration of a single oral dose of up to a maximum of 16 mg of CBP-174 or placebo. A total of 72 subjects were dosed with 8 subjects randomized in a 3:1 ratio to receive CBP-174 or placebo in each cohort.

CBP-174 was generally well-tolerated with no serious adverse events reported and no dose-limiting toxicities identified. Adverse events were predominantly mild in severity. Other safety parameters, including vital signs, ECGs, and laboratory results showed no clinically notable safety findings. Pharmacokinetics of CBP-174 exhibited rapid absorption with dose proportional increases in exposure followed by linear elimination.

This report on Form 6-K shall be deemed to be incorporated by reference into the registration statements on Form F-3 (Registration No. 333-264340) and Form S-8 (Registration Nos. 333-254524 and 333-266006) of the Company and to be a part thereof from the date on which this report is furnished, to the extent not superseded by documents or reports subsequently filed or furnished.

SIGNATURES

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.

 

Dated: August 30, 2022   CONNECT BIOPHARMA HOLDINGS LIMITED
  By   /s/ Steven Chan
    Name:   Steven Chan
    Title:   Chief Financial Officer