Ensovibep Clinical Results Call
EMPATHY Part A
January 2022
Molecular Partners AG, Switzerland
(SIX: MOLN, NASDAQ: MOLN)
1
Disclaimer
This presentation contains forward looking statements. Any statements contained in this presentation that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the clinical development of
Molecular Partners' current or future product candidates, including timing for the potential submission of emergency use authorization for ensovibep, expectations regarding timing for
reporting data from ongoing clinical trials or the initiation of future clinical trials, the potential therapeutic and clinical benefits of Molecular Partners' product candidates, the selection and development of future antiviral or other programs, and Molecular Partners' expected expenses and cash utilization for 2021 and that its current cash resources will be sufficient to fund its operations and capital expenditure requirements into H2 2023. These statements may be identified by words such as "anticipate", "believe", "could", "expect", "intend", "may", "plan", "potential", "will", "would" and similar expressions, although not all forward-looking statements may contain these identifying words, and are based on Molecular Partners AG's current beliefs and expectations. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Some of the key factors that could cause actual results to differ from our expectations include our plans to develop and potentially commercialize our product candidates; our reliance on third party partners and collaborators over which we may not always have full control; our ongoing and planned clinical trials and preclinical studies for our product candidates, including the timing of such trials and studies; the risk that the results of preclinical studies and clinical trials may not be predictive of future results in connection with future clinical trials; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; the extent of clinical trials potentially required for our product candidates; the clinical utility and ability to achieve market acceptance of our product candidates; the potential impact of the COVID19 pandemic on our operations or clinical trials; our plans and development of any new indications for our product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property position; our ability to identify and in-license additional product candidates; the adequacy of our cash resources and our anticipated cash utilization; and other risks and uncertainties that are described in the Risk Factors section of Molecular Partners' Registration Statement on Form F-1 filed with Securities and Exchange Commission (SEC) on June 14, 2021 and other filings Molecular Partners makes with the SEC. These documents are available on the Investors page of Molecular Partners' website at http://www.molecularpartners.com.
Any forward-looking statements speak only as of the date of this press release and are based on information available to Molecular Partners as of the date of this release, and Molecular Partners assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.
2
Ensovibep:
Advancement of COVID-19 Clinical Program
3
Structure and Features of Ensovibep Neutralizing the SARS-CoV-2 Spike Protein
3D model of a DARPin molecule
Characteristics
HSA DARPins
DARPin 1
DARPin 2
Three individual and linked DARPins bind and block the Spike protein of the virus
DARPin 3
Spike Protein
- High potency: high binding affinity and avidity leads to one of the highest anti-viral potencies reported to date
- Pan-variantactivity: cooperative binding of different sites allows blocking of all described variants of concern, so far
- Simple administration: long-half life, high solubility and low dose efficacy can allow for single administration via i.v., i.v. bolus, or s.c. injection
- Supply: microbial manufacturing in E.coli
DARPin®, designed ankyrin repeat proteins; RBD, receptor binding domain; HSA, human serum albumin; | |
SARS-Cov-2, Severe acute respiratory syndrome coronavirus 2. | 4 |
Walser M. Biorxiv. 2021. https://doi.org/10.1101/2020.08.25.256339
Ensovibep: Clinical Development Overview
- Empathy study (top-line analysis):
- Randomized 407 pts in Part A
- Mild or moderate symptoms
- Rapid antigen test positive
- Un-vaccinatedand vaccinated patients
- Met primary endpoint:
- Significant reduction in viral load ✓
- Clinically relevant secondary endpoints include:
- Reduction in risk of hospitalization and/or ER visits due to COVID-19, or deaths ✓
- Reduction in time to sustained clinical recovery ✓
- Safe and well-tolerated✓
- Phase 1 results / status (48 healthy subjects):
- Healthy volunteer safety trial
- Half-lifeestablished: 2-3 weeks
- i.v. infusion, i.v. bolus, s.c. injection
- Phase 2 single-arm results (12 pts):
- Patients, confirmed COVID positive, with symptoms
- Validation of methods and approach
- ACTIV-3Phase 3 interim results
- Hospitalized patients with confirmed COVID
- High dose of 600 mg tested in ~250 patients, stopped at futility analysis for lack of efficacy
- Safe and well-tolerated (included in ensovibep safety database)
- Novartis option exercise underway
5
This is an excerpt of the original content. To continue reading it, access the original document here.
Attachments
- Original Link
- Original Document
- Permalink
Disclaimer
Molecular Partners AG published this content on 10 January 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 10 January 2022 14:27:00 UTC.