Kenya Medical Research Institute

Tonix Pharmaceuticals Receives MCDC Grant to Advance TNX-801 Vaccine Against Smallpox and Mpox

2 months ago

• Tonix Pharmaceuticals has secured funding from the Medical CBRN Defense Consortium to develop TNX-801, a recombinant horsepox virus-based vaccine targeting both mpox and smallpox. • The single-dose vaccine demonstrates improved tolerability compared to traditional vaccinia-based vaccines, with preclinical studies showing effectiveness against monkeypox amid ongoing global outbreaks. • The grant will support comprehensive market analysis, target market identification, and commercialization planning for both government and private sectors.

Novel Mango-Flavored Pill Shows Promise in Eradicating Intestinal Worms

4 months ago

• A new mango-flavored pill combining two anti-parasitic drugs demonstrates promising results in clinical trials for treating intestinal worms. • The fixed-dose combination of albendazole and ivermectin aims to improve efficacy and reduce the risk of drug resistance in treating soil-transmitted helminths. • Clinical trials involving children in Ethiopia, Kenya, and Mozambique showed the pill's effectiveness, with regulatory decisions expected in early 2025. • Further trials are planned in Kenya and Ghana to assess the pill's impact on a larger population, potentially aiding WHO goals for disease elimination.

Largest-Ever Study Launched to Track Chikungunya Burden in East Africa

5 months ago

• A large-scale study, ACHIEVE, has been launched in East Africa to investigate the burden of chikungunya in Kenya and Tanzania. • The study will screen patients with fever or neurological symptoms for chikungunya at healthcare facilities across both countries starting in 2025. • Supported by USD 10.3 million from CEPI, the study aims to improve understanding of chikungunya and inform disease control strategies. • The research will also provide important data to advance the development and deployment of chikungunya vaccines in affected regions.

Kenya urged to approve Cabotegravir and Lenacapavir for HIV prevention

5 months ago

• Researchers in Kenya are advocating for the approval of Cabotegravir and Lenacapavir, two highly effective drugs for HIV prevention, to reduce the country's HIV burden. • Cabotegravir, an injectable drug by GSK, requires two initial injections followed by injections every eight weeks and has shown superior prevention rates compared to oral PrEP. • Lenacapavir, developed by Gilead Sciences, is another injectable option providing protection with an injection every six months, boasting nearly 100% prevention rate. • While Cabotegravir has been registered in Kenya, Lenacapavir is yet to be submitted for approval, and accessibility to both drugs remains a challenge due to high costs.

Tonix Pharmaceuticals' TNX-102 SL Awaits FDA Decision for Fibromyalgia Treatment

6 months ago

• Tonix Pharmaceuticals' TNX-102 SL, a non-opioid analgesic, has been assigned an FDA PDUFA goal date of August 15, 2025, for fibromyalgia treatment, potentially offering a new option for millions. • TNX-102 SL demonstrated significant pain reduction and improved sleep quality in Phase 3 trials, addressing key fibromyalgia symptoms with a well-tolerated safety profile. • The FDA previously granted Fast Track designation to TNX-102 SL, highlighting the urgent need for innovative treatments for fibromyalgia, a condition affecting mostly women. • If approved, TNX-102 SL could be the first in a new class of drugs for fibromyalgia in over 15 years, providing a novel approach to managing this chronic pain disorder.

Tonix Pharmaceuticals Seeks FDA Approval for TNX-102 SL in Fibromyalgia

6 months ago

• Tonix Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for TNX-102 SL for the treatment of fibromyalgia. • TNX-102 SL, a non-opioid analgesic, has shown statistically significant pain reduction in two Phase 3 trials for fibromyalgia. • The FDA is expected to decide on the NDA acceptance in December 2024, with a potential approval decision in 2025. • Tonix is also advancing its mpox vaccine candidate, TNX-801, with new data demonstrating tolerability in immunocompromised animals.

Ventyx Biosciences and Tonix Pharmaceuticals Report Pipeline Updates and Financial Results

6 months ago

• Ventyx Biosciences advances VTX3232 into Phase 2 trials for early Parkinson's and obesity, expecting topline results in H1 and H2 2025, respectively. • Tonix Pharmaceuticals submitted an NDA for TNX-102 SL for fibromyalgia, with a potential FDA decision expected in December 2024. • Tonix Pharmaceuticals secured a DoD contract worth up to $34 million for antiviral drug development and reported Q3 2024 product revenue of $2.8 million. • Ventyx Biosciences reported a cash balance of $274.8 million, expected to fund operations into at least H2 2026, while Tonix Pharmaceuticals reported $28.2 million in cash.

KEMRI Advocates for Approval of Cabotegravir and Lenacapavir for HIV Prevention in Kenya

6 months ago

• Kenya Medical Research Institute (KEMRI) urges the government to approve Cabotegravir and Lenacapavir, two highly effective HIV prevention drugs, to reduce the nation's HIV burden. • Clinical trials show Cabotegravir, an injectable drug by GlaxoSmithKline, surpasses oral PrEP efficacy, while Lenacapavir, from Gilead Sciences, offers near 100% prevention with six-month injections. • Despite FDA and EMA approvals, Kenya's Pharmacy and Poisons Board has been slow to approve Cabotegravir, hindering access to advanced HIV prevention methods. • With 1.6 million Kenyans living with HIV/AIDS, KEMRI emphasizes that approving these drugs could significantly decrease new infections and save lives.

Tonix Pharmaceuticals and KEMRI Partner to Advance TNX-801 Mpox Vaccine

7 months ago

• Tonix Pharmaceuticals collaborates with KEMRI to develop TNX-801, a live-virus vaccine, for mpox prevention. • A Phase I clinical study in Kenya will assess the safety, tolerability, and immunogenicity of TNX-801. • TNX-801 aligns with WHO's target product profile, offering single-dose, durable protection against mpox. • Preclinical data showed TNX-801's efficacy in animal models, preventing clinical disease and reducing viral shedding.