BridgeBio Pharma to Present Phase 2b Data and Pivotal Phase 3 Study Design of Encaleret in Autosomal Dominant Hypocalcemia Type 1 (ADH1) at the Endocrine Society (ENDO) 2022 Annual Conference
- BridgeBio will host an investor call on June 13, 2022, at 4:30 pm ET to discuss the Phase 2b study results and the planned pivotal Phase 3 study design
PALO ALTO, Calif., June 09, 2022 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that 24-week Phase 2b data of encaleret in patients with autosomal dominant hypocalcemia type 1 (ADH1) will be featured in an oral presentation at the Endocrine Society (ENDO) 2022 Annual Conference, taking place in Atlanta, GA on June 11 – 14, 2022.
At ENDO 2022, BridgeBio will also participate in a rapid-fire poster presentation and share poster presentations about its achondroplasia program, including preclinical data on hypochondroplasia as well as an ePoster about its congenital adrenal hyperplasia (CAH) program. Full oral presentation and poster details for the ADH1, achondroplasia and CAH programs are listed below.
ADH1 oral presentation details:
Encaleret (CLTX-305) restored mineral homeostasis in a Phase 2 study in autosomal dominant hypocalcemia type 1 (ADH1) Presenter: Rachel Gafni, M.D., senior research physician and head of the Mineral Homeostasis Studies Group of the National Institute of Dental and Craniofacial Research of the National Institutes of Health (NIH) Oral session date & time: Monday, June 13th at 11:00 am – 12:30 pm ET Oral presentation time: 11:15 – 11:30 am ET Location: A411 Session number: OR21
Achondroplasia poster and rapid-fire poster presentation details:
Evaluation of body mass index and metabolic parameters in children with achondroplasia participating in the PROPEL study Presenter: Daniela Rogoff, M.D., Ph.D., vice president of clinical development at QED Therapeutics, an affiliate company of BridgeBio Poster presentation date & time: Saturday, June 11th at 1:00 – 3:00 pm ET Location: Hall A1 Session number: PSAT105
Infigratinib in children with achondroplasia: Design of the PROPEL, PROPEL2 and PROPEL OLE studies Presenter: Elena Muslimova, M.D., Ph.D., medical director at QED Therapeutics Poster presentation date & time: Saturday, June 11th at 1:00 – 3:00 pm ET Location: Hall A1 Session number: PSAT106
Qualitative research in children and parents of children with achondroplasia to cognitively debrief three patient-reported outcome measures and confirm the content validity of a clinical-assessed measure Presenter: Elena Muslimova, M.D., Ph.D., medical director at QED Therapeutics Poster presentation date & time: Saturday, June 11th at 1:00 – 3:00 pm ET Location: Hall A1 Session number: PSAT102
Qualitative research in children with achondroplasia and parents of children with achondroplasia: Medical challenges and impacts Presenter: Elena Muslimova, M.D., Ph.D., medical director at QED Therapeutics Poster presentation date & time: Saturday, June 11th at 1:00 – 3:00 pm ET Location: Hall A1 Session number: PSAT103
Medical history of children enrolled in PROPEL: A prospective clinical assessment study in children with achondroplasia Presenter: Melita Irving, clinical geneticist at Guy's and St Thomas' NHS Foundation Trust, London Poster presentation date, time & location: Monday, June 13th at 12:30 – 2:30 pm ET in Hall A1 Rapid-fire poster presentation date, time & location: Monday, June 13th at 12:58 – 1:03 pm ET in Pod 9 Session number: PMON326
Low-dose infigratinib, an oral selective fibroblast growth factor receptor tyrosine kinase inhibitor, demonstrates activity in a preclinical model of hypochondroplasia Presenter: Carl Dambkowski, M.D., chief medical officer of QED Therapeutics Poster presentation date & time: Monday, June 13th at 12:30 – 2:30 pm ET Location: Hall A1 Session number: PMON30
CAH ePoster details:
Initial lessons from a pre-screening protocol to identify participants with classic CAH potentially eligible for gene therapy treatment with BBP-631, an adeno associated virus (AAV) serotype 5-based recombinant vector encoding the human CYP21A2 gene Presenter: Kamal Bharucha, M.D., Ph.D., vice president of clinical development at BridgeBio Gene Therapy
Webcast Information BridgeBio will host an investor call and simultaneous webcast to discuss the 24-week Phase 2b data and pivotal Phase 3 study design for encaleret in patients with autosomal dominant hypocalcemia type 1 on June 13, 2022 at 4:30 pm ET. To access this call, dial (800) 379-2666 and enter conference ID 7644119. A link to the webcast may be accessed from the event calendar page of BridgeBio’s website at https://investor.bridgebio.com/. A replay of the conference call and webcast will be archived on the Company’s website and will be available for at least 30 days following the event.
About BridgeBio Pharma, Inc. BridgeBio Pharma, Inc. (BridgeBio) is a commercial-stage biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio’s pipeline of development programs ranges from early science to advanced clinical trials. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com and follow us on LinkedIn and Twitter..
BridgeBio Pharma, Inc. Forward-Looking Statements This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements relating to expectations, plans and prospects regarding the preclinical and clinical development plans, clinical trial designs, clinical and therapeutic potential, and strategy of our product candidates, including, but not limited to: interim results from the Phase 2b proof-of-concept, open-label study of encaleret for the treatment of Autosomal Dominant Hypocalcemia Type 1 (ADH1); and the timing of these events, reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to: ongoing data from our ongoing Phase 2b proof-of-concept, open-label study of encaleret for the treatment of ADH1 not being indicative of final data; the potential size of the target patient population for ADH1 not being as large as anticipated; encaleret not being well-tolerated, with serious adverse events and adverse events of moderate or severe intensity being reported in the final Phase 2b study data; encaleret not continuing to demonstrate that it may be an efficacious therapy option for ADH1 based on the final Phase 2b data; encaleret not being the first approved therapy option indicated specifically for the treatment of ADH1, if the development program is not successful or if a competing therapy option is approved; the design and success of ongoing and planned clinical trials, future regulatory filings, approvals and/or sales; despite having ongoing and future interactions with the FDA or other regulatory agencies to discuss potential paths to registration prior to initiation of a Phase 3 registrational study of encaleret in patients with ADH1, the FDA or such other regulatory agencies may not agree with our regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; the continuing success of our close collaboration between the National Institute of Dental and Craniofacial Research at the National Institutes of Health; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those risks set forth in the Risk Factors section of our most recent annual report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and our other SEC filings. Moreover, BridgeBio operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of BridgeBio’s management as of the date of this release and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
