SXTP Corporate Deck
SXTP Corporate Deck
SXTP Corporate Deck
■ Safety Profile
■ 8 published clinical studies involving > 1,100 patients
■ Overall adverse event rate of tafenoquine 200 mg weekly for 52 weeks is comparable to placebo.
■ G6PD screening required prior to use
■ See paper in Travel Medicine & Infectious Disease [Long-term safety of the tafenoquine antimalarial chemoprophylaxis regimen: A 12-month, randomized,
double-blind, placebo-controlled trial - ScienceDirect]
C-COVID-193 D – Babesiosis4
ACLR8-LR*** SUSPENDED
Tafenoquine (ARAKODA regimen): PENDING ASSESSMENT OF
COVID-19 INDICATIONS FEASIBILITY OF CONDUCTING
EX U.S.
Tafenoquine: NOTES:
Candidiasis & *ARAKODA® is commercially available in the U.S. for malaria prevention and will be the subject of targeted marketing
fungal
efforts in 2023 and 2024, supported by the hiring of a commercial operations executive (pending). **Existing funds will
pneumonias#
support achieving FDA clearance, but execution of the Phase IIB/III treatment study will require additional funds. ***
ACLR8-LR was to evaluate the ARAKODA regimen of tafenoquine as a potential COVID-19 therapeutic in patients with
low risk of disease progression but has been suspended following advice from FDA suggesting its execution in the U.S.
Celgosivir:
was unfeasible. The Company may revisit this in the future of a low-cost Phase IIB study could be performed in an ex U.S.
Respiratory jurisdiction. #Both these products have been the subject of clinical studies for other indications. Additional non-clinical
viruses & efficacy and mechanism of action studies are required before committing to further clinical development. These activities
dengue# will be conducted in 2023 only if resources permit. ## Protocol on clinicaltrials.gov will be updated when revised IND
submitted to FDA. Timelines assume IND resubmission in Q4 2023.
Phase IIB/III
Low Risk
Seek FDA Hospitalized Patients
File sNDA
clearance/Type C Summer 2024
[If FDA
Meeting
TQ + SOC v Placebo + SOC concurs]
Q4 2023
Proposed 20 Patients
Endpoint: Time To Molecular Clearance (TTMC- time to first of two consecutive
negative PCRs)
PBMs
Various
Territory Partner
■ U.S. Celgosivir Patents Europe Scandinavian Biopharma
■ Dengue/RSV (4 issued/2 in progress) Australia, NZ, Pacific Biocelect
■ COVID-19 licensed from FSU (1 issued/1 in progress)
Islands
Canada, Latin America, Knight Therapeutics
Israel, Russia
■ International Patents
■ 6/2 for Celgosivir issued/in progress, 1/8 for tafenoquine issued/in progress
Research and licensing TafenoquineIND filed ARAKODA enters Key clinical studies IPO on NASDAQ
agreement for First clinical trial(s) USsupply chain, completed:
tafenoquine (ARAKODA) completed commercial - Long term safety
signed with USArmy infrastructure - COVID-19Phase IIA
established
OTHERANTICIPATEDMILESTONES
■ Detailed TAM Estimates for tick-borne diseases ■ Trade & Scientific Conferences
§ Arakoda Regimen of Tafenoquine – Research agenda involving babesiosis and other diseases
§ Malaria, COVID-19, fungal, tick-borne illness of interest to the Company affect millions and are associated with a potentially high revenue unmet medical need
§ Company has strong IP for malaria, COVID-19, and other indications
§ Accelerated clinical recovery from babesiosis is suggested by case studies of immunosuppressed patients administered tafenoquine
§ 2024: Execute Phase IIA treatment study in hospitalized babesiosis patients
§ 2025: sNDA and/or confirmatory babesiosis patient study
Patrick Gaynes
patrickgaynes@60degrespharma.com
1025 Connecticut Avenue NW 310-989-5666
Suite 1000
Washington, DC 20036
60degreespharma.com