UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 2.02. | Results of Operations and Financial Condition. |
On August 4, 2022, BridgeBio Pharma, Inc. (the “Company”) reported recent business updates and its financial results for the second quarter ended June 30, 2022. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in Item 2.02 of this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing.
| Item 8.01. | Other Events. |
Recent Developments
Phase 2b Data for Encaleret in Autosomal Dominant Hypocalcemia Type 1 and Design of Phase 3 Pivotal Study
On June 13, 2022, the Company announced positive data from the Phase 2b study of encaleret in patients with autosomal dominant hypocalcemia type 1 (“ADH1”). Thirteen adults with ADH1 caused by nine unique Calcium-sensing receptor variants participated in the three-period, Phase 2b, open-label, dose-ranging study. Oral calcium and activated vitamin D supplements were discontinued prior to encaleret initiation. Periods 1 and 2 each evaluated encaleret over the course of five inpatient days and Period 3 included a 24-week outpatient evaluation. Based on 24-week outpatient data, the Company observed:
| • | Mean values of blood calcium, urinary calcium, and blood parathyroid hormone, key biochemical parameters of mineral homeostasis, were normalized by Period 2, Day 5 and were sustained through Period 3, Week 24 of the trial |
| • | At Week 24 of encaleret treatment, 92% (12/13) of participants had achieved normal trough blood calcium levels in the absence of extra-dietary calcium supplements and active vitamin D, and 77% (10/13) of participants had normal urinary calcium excretion |
| • | Encaleret was well-tolerated with no serious adverse events reported; there were no treatment discontinuations or study withdrawals |
The participants who completed Period 3 of the study were eligible to continue in an open-label extension of up to 25 months. The planned Phase 3 pivotal study in patients with ADH1 is designed as a randomized, open-label, two-arm study comparing the effect of encaleret to standard of care on blood and urine calcium for 24 weeks. The Company plans to initiate the Phase 3 trial in the second half of 2022 with an expected readout of top-line data at the end of 2023.
Selection of KRAS G12C Development Candidate
On August 4, 2022, the Company announced the selection of a next-generation KRAS G12C dual inhibitor development candidate, a small molecule that directly binds and inhibits KRAS G12C in both its active (GTP bound) and inactive (GDP bound) conformations. The Company currently intends to begin clinical work in mid-2023.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit Number |
Description | |
| 99.1 | Press Release dated August 4, 2022, furnished herewith | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
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 hereunto duly authorized.
| BridgeBio Pharma, Inc. | ||||||
| Date: August 4, 2022 | /s/ Brian C. Stephenson | |||||
| Brian C. Stephenson | ||||||
| Chief Financial Officer | ||||||